Hand hygiene of kindergarten children—Understanding the effect of live feedback on handwashing behaviour, self-efficacy, and motivation of young children: Protocol for a multi-arm cluster randomized controlled trial

Glenda Dangis; Kirsi Terho; Joanna Graichen; Sebastian A Günther; Riitta Rosio; Sanna Salanterä; Thorsten Staake; Carlo Stingl; Anni Pakarinen

doi:10.1371/journal.pone.0280686

. 2023 Jan 24;18(1):e0280686. doi: 10.1371/journal.pone.0280686

Hand hygiene of kindergarten children—Understanding the effect of live feedback on handwashing behaviour, self-efficacy, and motivation of young children: Protocol for a multi-arm cluster randomized controlled trial

Glenda Dangis ^1,^*,^#, Kirsi Terho ^1,^2,^#, Joanna Graichen ^3,^#, Sebastian A Günther ³, Riitta Rosio ¹, Sanna Salanterä ^1,², Thorsten Staake ³, Carlo Stingl ³, Anni Pakarinen ^1,^#

Editor: Maiken Pontoppidan⁴

PMCID: PMC9873181 PMID: 36693062

Abstract

Early implementation of interventions at a young age fosters behaviour changes and helps to adopt behaviours that promote health. Digital technologies may help to promote the hand hygiene behaviour of children. However, there is a lack of digital feedback interventions focusing on the hand hygiene behaviour of preschool children in childhood education and care settings. This study protocol aims to describe a study that evaluates the effectiveness of a gamified live feedback intervention and explores underlying behavioural theories in achieving better hand hygiene behaviour of preschool children in early childhood education and care settings. This study will be a four-arm cluster randomized controlled trial with three phases and a twelve-month follow-up by country stratification. The sample size is 106 children of which one cluster will have a minimum number of 40 children. During the baseline phase, all groups will have automated monitoring systems installed. In the intervention phase, the control group will have no screen activity. The intervention groups will have feedback displays during the handwashing activity. Intervention A will receive instructions, and intervention B and C groups will receive instructions and a reward. In the post-intervention phase, all the groups will have no screen activity except intervention C which will receive instructions from the screen but no reward. The outcome measures will be hand hygiene behaviour, self-efficacy, and intrinsic motivation. Outcome measures will be collected at baseline, intervention, and post-intervention phases and a 12-month follow-up. The data will be analysed with quantitative and qualitative methods. The findings of the planned study will provide whether this gamified live feedback intervention can be recommended to be used in educational settings to improve the hand hygiene behaviour of preschool children to promote health.

The trial is registered with ClinicalTrials.gov (registration number NCT05395988 https://clinicaltrials.gov/ct2/show/NCT05395988?term=NCT05395988&draw=2&rank=1).

Introduction

Children’s development is motivated by their efforts to understand the unknown. They learn by experimenting and doing, it is when curiosity is stimulated, that children gain knowledge [1]. From birth to 12 years old, children are active, eager to connect, and motivated social learners, making this development stage ideal for enhancing essential attitudes and behaviours [2].

Educational settings are important places to instil healthful behaviours in children and they offer environments that impact children’s behaviour [3]. Early implementation of interventions at a young age fosters behaviour change and helps to adopt behaviours that promote health [4]. It is known that children’s behaviour can be carried out to adulthood [1,2]. The guidance supports the development of their learning abilities, thinking, habits, and behaviours, and find their independence.

Highly infectious illnesses rapidly spread in semi-close places such as in educational settings [5]. Children cared for in day-care and preschool education have higher risks of acquiring infections than those cared for at home [6]. Children’s bodies are vulnerable which make them susceptible to infections [5]. The common infectious illnesses of children are respiratory and gastrointestinal [3,5]. Illnesses that can be prevented through hand hygiene.

Hand hygiene is the most cost-effective method and fundamental behaviour to prevent the spread of infections in educational settings [5,7]. It also reduces infectious illnesses-related absences among children [7]. The commonly used method for hand hygiene promotion is through health education but promoting better hand hygiene practices is more effective [3]. Limited data are available on monitoring hand hygiene practices among children in educational settings and it is challenging because it demands time and resources.

Hand hygiene interventions are any form of techniques to be performed to promote hand hygiene behaviour [5,8]. Hand hygiene interventions that could enhance psychosocial variables such as behavioural capacity, attitudes, and subjective norms are widely used in educational settings [3,9]. Also, incorporating behaviour change techniques and play in hand hygiene interventions for children provide effective results in promoting hand hygiene behaviour [10,11] and building self-efficacy in handwashing [12,13]. Many of these studies that used hand hygiene interventions among children in educational settings evaluated effectiveness in reducing infectious related-absenteeism [5,11,14], decreasing infections [5,7], hand hygiene compliance [4,15,16] and microbiological effect [14].

Determining the mediating variables of health behaviours create a foundation for the success of the health behavioural change interventions [9,17]. One of these variables is self-efficacy, a belief in one’s capabilities to accomplish a certain task and could account for the effect of an intervention [18]. It is regarded that self-efficacy is one of the variables that influence the adoption and maintenance of health behaviour [12,19]. Motivation also plays a significant role in learning and behaviour changes [8,12]. Children with a higher sense of self-efficacy tend to have better motivation [12,20].

The use of gamification as interventions have been growing due to their enjoyable elements [21]. Gamification is the use of gamified elements in non-gaming settings [22]. Studies showed that users of gamified interventions appeared to have increased motivation to perform tasks and maintain healthy behaviours [21,23,24]. Enhancing children’s experiences with positive and enjoyable approaches can support them grow into healthy adults [25].

Young children’s experiences with technology are becoming part of the daily context of their lives(26). Appropriate frameworks for the use of technology and interactive media are tools that can help to promote effective learning and development [26,27]. Novel digital technologies adopted in the educational environment may help to promote sustainable handwashing behaviour of children across various settings [28]. However, current digital health technologies have been developed mainly for clinical settings [29]. This study will investigate the effect of gamified digital intervention with live feedback on preschool children aged three to six years old in early childhood education and care settings using a cluster randomized controlled trial.

Methods

Aim of the study

This article introduces the protocol for the Candy study: Improving children’s hand hygiene which aims to evaluate the effectiveness of a gamified live feedback intervention and explore underlying behavioural theories in achieving better hand hygiene behaviour of preschool children aged three to six years old in early childhood education and care setting to promote health.

Objective and Hypotheses

This study will evaluate the effect of the gamified live feedback intervention on promoting hand hygiene behaviour and increasing self-efficacy levels of preschool children, and if motivation crowding-out will happen. Crowding out is an effect where there is a decrease or lack of motivation to perform handwashing because the reward is already known or expected [30].

Hypotheses

Main effects: Control, Intervention A (instruction), Intervention B (instruction plus reward), and Intervention C (instruction plus reward and instruction in post-intervention phase) groups

H1: Feedback display will increase handwashing activity in the kindergarten (in the short term) during intervention phase
- For intervention A, B, and C groups
- For intervention B and C groups more than intervention A group
H2: Handwashing activity in the kindergartens will decline with time (while the display will still be turned on)
- For intervention A group less than intervention B and C groups during the beginning of the post-intervention phase
- For intervention B group less than intervention C group during post-intervention phase.
- For control group less than intervention A, B, and C groups in all phases.
- Motivation crowding out: Measurement-based
H3a: Effect will partially persist, when feedback display in kindergarten will be turned off during the beginning of post-intervention phase. For intervention C groups less than intervention A and B groups. (Explanation: habit will be formed, there will be partial motivation crowding out, impact in increased self-efficacy will be stronger)
H3b: Effect will vanish and handwashing will return to baseline behaviour for intervention B group in post-intervention phase. (Possible explanation: no habit will be formed, there will be no motivation crowding out)
H3c: Effect will vanish and handwashing activity will drop below baseline behaviour for intervention A group in post-intervention phase. (Possible explanation: there will be crowding out)
- Acquisition of competences and self-efficacy: Intervention A, B, and C groups
H4a: Feedback intervention will increase competences and self-efficacy level of children after the intervention phase–for intervention B and C groups stronger than for intervention A group
H4b: Feedback intervention will increase competences and self-efficacy level of children after post-intervention phase–for intervention C group stronger than for intervention B group and for intervention B group stronger than for intervention A group.

Trial design

In this article, we describe a clinical protocol for a study using a cluster randomized controlled trial following the Standard Protocol Items: Recommended for Interventional Trials (SPIRIT) guidelines [31] (S1 Table). The study design follows the CONSORT guidelines for cluster Randomized Controlled Trials [32]. The SPIRIT schedule enrolment is reported in Fig 1.

This study will be a four-arm cluster randomized controlled trial study with three phases and a twelve-month follow-up by country stratification. This study will evaluate the effectiveness of the gamified live feedback intervention on children’s handwashing behaviour, self-efficacy, and motivation in three different phases: the baseline, intervention, and post-intervention phases. In Finland, there will be a twelve-month follow-up after the baseline phase. This study will consist of four groups, the control group, and three different intervention groups. All the groups will have automated monitoring systems installed before the start of the baseline phase and will be available in all phases. The system will be de-installed after the post-intervention phase.

During the baseline phase, all the groups will have no screen activity. During the intervention phase, the control group will have no screen activity. The intervention A group will have a screen display providing handwashing instructions but no reward, and the intervention B and C groups will receive handwashing instructions and rewards from the screen display. During the post-intervention phase, all the groups will have no screen activity except the intervention C group which will receive handwashing instructions but no reward (Fig 2).

The design of this study is cluster randomized controlled, where one kindergarten serves as one cluster. Clustering will be used since the hand hygiene intervention is designed to be installed in certain areas to be used in groups. Kindergartens will be assigned as clusters rather than individuals to minimize the potential contamination among the groups, and to more accurately follow the process that will be taken at scale [33,34].

Theoretical framework

This study will use Albert Bandura’s Social Cognitive Theory (SCT) as the theoretical framework. According to this theory, the three factors: personal, environmental, and behavioural determine human behaviour and are mutually interacting among each other [18]. In this conceptual model, the human agency is functioning within the interactional causal structure to obtain and maintain a behaviour (Fig 3).

The reciprocal causation, action, cognitive, and other personal and environmental factors function as interacting determinants. This model states that individuals are not autonomous agents, but they are making a causal contribution to their motivation and action within the triadic reciprocal causation [35]. In addition, motivation is self-regulated by the influence of proactive and feedback mechanisms, but the adaptation of humans will depend on the forethought of feedback control of action [18].

The technology to be used in this study that provides live feedback (instructions and reward) when performing handwashing can build positive outcome expectations, enhance self-efficacy, and attain a goal (Fig 3). This kind of intervention can promote to maintain and improve hand hygiene behaviour by enhancing motivation and self-efficacy. Figs 3 and 4 show how the theory is applied using the live feedback intervention.

Study setting

This study will be conducted in kindergartens of different locations around Turku, Finland and Bamberg, Germany. In Germany and in Finland, kindergartens are under the supervision of Early Childhood Education and Care (ECEC) [36]. It is a part of Finnish and German education systems which support the children’s development and focus on learning through play. It is an essential stage on the child’s path of growing and learning. ECEC is a systematic and goal-oriented entity that includes upbringing, education, and care, specifically emphasizing pedagogy aiming to promote and support holistic growth, development, health, and wellbeing (Act on Early Childhood and Care). Groups of children in the kindergartens may be formed in various ways, considering the children’s ages or needs for support. Distribution on staffing and maximum group sizes are considered in forming the groups of children. The kindergarten staff are composed of preschool teachers and assistants who are responsible for the daily activities of the children [36–39].

Eligibility criteria

The kindergartens around Turku, Finland and Bamberg, Germany will be eligible to participate in the study. The criteria for the participants will be A) children enrolled in the kindergartens aged two years and six months to six years old, their parents or legal guardians, and kindergarten staff who will provide observational measures; B) give informed consent by both the child (verbal consent) and parents/legal guardians and kindergarten staff; C) can understand and communicate Finnish or German. The exclusion criteria will be participants that cannot answer the assessment data.

Outcome measures

The primary outcome is the hand hygiene behaviour of the children. The system will measure the hand hygiene activities which includes the start time of extraction, water volume, water temperature, and end time of extraction; from these data, the following data will be derived: average flow rates, approximation of energy consumption, quality and duration of handwashing, and time stamp of soap used.

The secondary outcomes are self-efficacy, intrinsic motivation, hand hygiene behaviour at home from parents’ survey, hand hygiene behaviour in kindergartens from kindergarten staff, and hand hygiene behaviour in the kindergarten by observation sessions. Self-efficacy and intrinsic motivation will be measured from the children’s one-on-one interview, a three-point Likert scale with open-ended questions. The children will be asked easy and simple questions about their hand hygiene performance, self-regulation on motivation, emotional states, and decisional in performing handwashing. They will respond by pointing their answer from the three smiley faces (sad, neutral, and happy). Colourful smiley faces will be constructed to catch the attention of the children. Each question is followed by open-ended questions to explore their opinions regarding the topic asked and to support their answers. The children interview includes introduction of the interviewer and asking simple questions regarding their day or regular activities for the children to feel comfortable. The parent survey will be an electronic survey composed of five-point Likert and open-ended questions about the observed hand hygiene behaviour of the children at home. The kindergarten staff interview will also include five-point Likert and open-ended questions, evaluating the hand hygiene behaviour of the children in the kindergartens. The assistant researchers will observe the hand hygiene behaviour of the children during the handwashing activity in the kindergartens. Observation sessions will include a checklist consisting of the phases of handwashing, the checklist will follow the hand hygiene guideline of the United Nations Children Fund (UNICEF).

The tertiary outcome is the number of sick leave days of the children and kindergarten staff (applies in Finland) considering the seasonal change.

Study participants

The population of the study will be the preschool children who are enrolled in kindergartens. The children aged between 2.6 to 6 years old, their parents, or legal guardians, and the kindergarten staff who will be providing the observational measures.

Sample size

The sample size is calculated based on the significant effects found during the pre-study. In the pre-study, 10,000 handwashing events were recorded over a period of 42 days in a treatment group (n = 82 children in two clusters) and a control group (n = 53 children in two clusters). Using Cohen’s power analysis with f² = 0,35 (large effect size) and power level of 0.8 and 2 predictors and a probability level of 0.05 leads to n = 31. However, since randomization is on a cluster level, the n must be increased. With the ICC from the pre-study of 0.062, and estimated cluster size (size of each kindergarten) of 40 children, we calculate the design effect:

D = 1 + (m - 1) * I C C = 1 + (40 - 1) * 0.062 = 3.418

Thus, we need to increase the sample size by 3.418 compared to individual randomization, due to cluster randomization leading to 106 participants (n = 31 * 4.418 = 106). With the assumption of a cluster size of 40 children per kindergarten, this leads to three kindergartens that need to participate in the study. Each kindergarten represents one cluster and gets assigned to be the control, the intervention A, B, and C groups. Two intervention groups will be covered by one cluster.

Recruitment

The recruitment process was started through the kindergartens’ software platforms, email, presenting a short demo video on the platforms regarding the study, and information leaflets. A website link of the study’s information, recruitment, and registration was provided in the medium used in the kindergartens. In Finland, the registration will be through a webropol link and emails. In Germany, the registration will be through emails. The anonymity of the participants from the research team will be secured during the process.

Randomization

The cluster randomization will be at the kindergarten level. Kindergartens will be randomly assigned to control or intervention groups by two researchers that are not members of the research team and are stratified by country. One kindergarten serves as one cluster. Simple randomization will be used which will be drawing lots, where each cluster will be assigned a number in a piece of paper. The parents will enrol their children for participation in the study within the time set through the website link provided and email.

No information will be given regarding the allocation. Allocation will be about four weeks before the start of the baseline phase and will be conducted by the two non-member researchers. They will generate the allocation sequence, enroll the participants, and assign them to control or intervention groups. There will be complete concealment of the allocation from the members of the research team and the participants, to exclude the possibility of predicting the next allocation [33].

Blinding

Due to the intervention’s design and purpose, the research team and the participants will have the possibility to know the assignment. Thereby, this study will use double-blinding in which the children, parents, and kindergarten staff, and the statistician will be unaware of which group will receive the content of the intervention. In the informational letters, the feedback display will not be mentioned, the children and kindergarten staff will only know during the intervention phase. Assistant researchers will also be hired to interact with the participants. They will be given limited information, will be unaware of the study’s design, and which group received the content of the intervention.

Intervention development

The technology for the gamified digital feedback intervention was developed in Germany and the content was developed by the whole research team. It is a child-centred smart hand hygiene intervention. The installations at each washbasin are IoT-based. Each installation will consist of a touchless faucet powered by a digital power box (a), a soap sensor (b), a feedback display (only for treatment groups) (c), and a gateway (d), which connects to the devices (a-c) via Bluetooth and relays data to a cloud infrastructure (e). Connected Information Systems (f), such as dashboards to monitor hand hygiene, can access the system via this cloud infrastructure [40] (Fig 5).

The digital power box is a device developed by Amphiro AG that equips faucets with digital functionalities. The device will be installed between the water wall outlet and the faucet in the kindergartens. It measures, processes, and sends the individual water withdrawal data to an LTE Gateway. The energy required for its operation will be generated by an integrated micro-turbine, which eliminates the need for an external power supply (often unavailable at the installation site) or batteries (which need to be replaced regularly and are therefore impractical for many maintenance processes).

This study will use a well-tested technology. It is currently used in clinical settings to improve the hand hygiene of health care professionals. The technology was tested during a pre-study conducted in spring of 2021. This kind of similar live feedback approach used in the field studies has shown larger effects on routine behaviour [41]. The screen display will provide an educational video showing instructions on how to do handwashing when hands are dirty for the children to follow (Fig 6). The handwashing instruction was guided by the World Health Organization’s “How to Handwash” poster. When the handwashing is done correctly (based on the water and soap usage), a reward of animal animation will appear on the screen display (Fig 7). The live feedback display will enhance the children to do handwashing correctly, thus improving hand hygiene practices.

Implementation

This study will be composed of three phases, the baseline, intervention, post-intervention, and a twelve-month follow-up (Fig 2). The first phase will be the baseline which will last for three weeks. The systems will be installed in the kindergarten sinks which will collect data from the handwashing activities, but it will not provide any feedback or screen activity. A “how-to” teaching session (video-based training) will be held in each kindergarten in the middle of the baseline phase for all children to learn the same hand hygiene information. The second phase will be the treatment and will last for three weeks. The third phase will be the post-intervention, and it will also last for three weeks. After this phase, the systems will be de-installed from all the kindergarten sinks. In Finland, there will be a twelve-month follow-up after the intervention.

The control group will have no screen display next to the sink throughout the study. The intervention A (instruction) group will receive instructions from the screen display next to each sink where handwashing instructions are shown during the handwashing activity but no reward after. The intervention B (reward) and intervention C (reward plus instruction) groups will receive instructions and rewards shown on a screen display right next to the sink during the intervention phase. In these groups, handwashing instruction is shown during the handwashing activity and if handwashing is done correctly (based on time and soap usage), a reward of animal animation is shown on the screen, see Figs 6 and 7. During the post-intervention phase, the intervention C group will remain to have the screen display receiving instructions with no reward. In Finland, sick leave days of the children and kindergarten staff will be tracked (Fig 8).

To improve the adherence of the participants to the study, the research team will maintain the engagement, encourage retention, and thank the kindergarten managers, staff, children, and parents. Named persons from the researcher team call and pay visits to the study settings every now and then if the kindergarten personnel permits. Contact information of the research team will be provided to the kindergarten staff and parents before the trial. The participants will be reminded through email about the oncoming surveys and interviews, and they will be updated about the progress of the study.

Data collection

This study will start in mid-year of 2022 and will last for a year. The data will be analysed using quantitative and qualitative methods. The child’s age and gender will be collected. The implementation phases and timeline of the data collection are shown in Figs 1 and 2.

The handwashing activity data from the system will be recorded every day during the baseline, intervention, and post-intervention phases. The parent survey data will be given and collected within the last week of the intervention phase. The kindergarten staff interview data will be collected during the last week of the intervention phase and right in the beginning week of the post-intervention phase to evaluate the observed effect of children’s hand hygiene behaviour and reactions towards the removal of the instructions and reward. The children’s observation sessions and interviews will be collected during the last weeks of the baseline, intervention, and post-intervention phases. The number of sick leave days will be collected from the sick leave records provided by the kindergarten staff one year before and after the start of the baseline phase.

The follow-up strategy will include sending updates of the study phases through email to the kindergarten managers and staff. The email includes the details of reminding how and when the participants will be contacted for follow-up. It will also include updates on the contact information of the participants.

Data analyses

Data will be analysed using qualitative and statistical methods. All eligible participants will be included in the analysis. The statistical analyses will be performed with R. The categorical and numerical data will be analysed using one-way analysis of variance (ANOVA). Qualitative analysis will be presented thematically [42].

For the measurement data from the system:

Data pre-processing: Data will be investigated where water and soaping data are combined to single handwashing procedures. Data points that are not valid (outside of kindergarten opening hours) will be removed. The descriptive statistics of the clusters, randomization checks, ICC (intracluster correlation) will be calculated. The data will be analyzed using linear fixed-effect regression model for panel data, and dependent variable soaping time. The four groups will be compared in baseline, intervention, and post-intervention phases.

For the survey and staff interview data:

The comparison among the groups will be implemented using random effects regression, allowing for the clustered nature of the data, and adjusted using the covariates of the adjusted analyses (when a small number of clusters are present) [43]. Simple bias analysis will be used to quantify the uncertainty of the biases such as confounding variables [33]. The qualitative results of the survey and kindergarten staff interview will be analysed and compared thematically. The four groups will be compared after intervention phase.

For the children interview and observation data:

The analyses will be compared among groups based on the complete data only. The comparative analyses approach used to calculate the observation, survey, and staff interview will be used. The self-efficacy measurement scale will be developed and evaluated for its psychometric properties [44,45]. The qualitative result of the observation and interviews will be analysed and compared thematically [42]. Children who will participate the interview at one time point will be considered as missing data, these will be excluded from the analysis. The four groups will be compared in baseline, intervention, and post-intervention phases.

For the sickness day data:

The total sick leave days are compared among the groups one year before and after the start of the baseline phase.

The statisticians of the two universities will validate the statistical results of the data.

Data management

The anonymity of the participants using the faucets will be preserved as no person-specific data is collected. The experimental setup and data collection will not allow the collection of personal data and draw conclusions about the individuals. However, since this study will be a cluster randomized trial, the data collected will be the summary data for each arm. In addition, consent will be asked for the collection and storing of the observation, survey, interview, and sick leave data from the participating children, parents, and kindergarten staff. The behavioural data of the experiments will be stored in associated databases. All the data CSV files will be used anonymously. The data collected will be stored in both universities.

Research results will only be published in an anonymized form that does not allow conclusions to be drawn about each child. To ensure that behavioural data is protected from being captured by a third party, access to all critical infrastructure services will require authentication and authorization. In case a third party steals a faucet, the faucet’s access to the server will be remotely disabled. The documentation and the software components will be stored in git-repositories which have a version control functionality. The data communication and data storage will comply with GDPR accordingly.

Data monitoring

The data will be handled in a safe environment and will not be distributed among groups. This behavioural intervention poses a very low risk, it does not require trial steering or data monitoring committee [46].

Auditing

No auditing will be planned.

Access to data

Only authorized members of the research team will have access to the collected data.

Ethical considerations

This study Candy–Hand hygiene for children, full-scale study was reviewed and granted ethical approval by the Health Care Division of the Ethics Committee for Human Sciences of the University of Turku (S1 File) in November 2021 and Ethics Committee of the University of Bamberg (S2 File) in January 2022. This study will comply with the ethical principles for research with human participants involving minors provided by the German Research Foundation [47] and Finnish National Board on Research Integrity [48]. This study will involve minors, and will strictly follow the ethical research involving children [49], which have the right to be informed about the study in a way that they can understand and give their consent to participate in the study. The participants will give their informed consent to voluntarily participate or refuse to participate and to withdraw at any time during the study without any negative consequences. The participants will receive information letter about the contents and truthful aims of the study and any potential harms and risks. Inform consent and information letters will be in electronic and paper forms. The children will be informed about the study in an understandable manner and will give their consent verbally to participate in the study. The participation of the children will be primarily decided by the parent or legal guardian. The researchers will always respect the autonomy and voluntary participation of the participants. There will be no personal data collected during the study, the identity of the participants will remain anonymous. The data collected will be used and kept confidentially for research purposes only. The data will be stored for at least 10 years after the study has been completed.

Dissemination and protocol amendments

The results from this study will be published in a peer-reviewed journal irrespective of the study results. Authorship of publications will be granted according to the criteria of the International Committee of Medical Editors. We plan to make the anonymized data set, including the data from the published articles, available as a supplementary file of the main publication.

Discussion

The gamified live feedback intervention aims to improve the hand hygiene practices of preschool children in kindergartens. By giving real-time feedback (handwashing instructions and rewards) during the handwashing activity, the self-efficacy and motivation of the children are enhanced, attitude and confidence are boosted which leads to improvement of hand hygiene behaviour. A promising hand hygiene behaviour change intervention should include “demonstration of behaviour”, “instruction on how to perform the behaviour”, and “adding objects to the environment” such as installing handwashing stations and providing soap [10]. It is important for the children to understand how to perform handwashing in a correct way and provide the right tools to be able to do so [10]. Digital technologies such as computer games, videos, and video cameras have shown to improve and monitor handwashing behaviour, self-efficacy, and hygiene knowledge among young children in educational settings over a short period of time [28]. However, combinations of sensor and digital feedback technology have not been used in the studies. Another challenge is the lack of behavioural theories used in previous studies in the design stage. To our knowledge, this study will be the first to implement a gamified live feedback display focusing on improving the hand hygiene behaviour of children aged three to six years old in early childhood education and care setting.

This study will use multiple measurements such as a monitoring system, survey, interview, and observation to assess hand hygiene behaviour, self-efficacy, and motivation. This will provide versatile data to support the effectiveness of the intervention. It will also provide information if self-efficacy and motivation play important roles in attaining hand hygiene behaviour. Another is to provide further evidence if preschool children’s self-efficacy is a significant variable in determining the effectiveness of the intervention and obtaining hand hygiene behaviour. In this study, hand hygiene self-efficacy for preschool children will be developed and evaluated which up to these days none have been developed. This study will also measure the sick leave days of the children and kindergarten staff which could give information if using the intervention is effective in reducing the number of sick leave days. Hand hygiene interventions in educational settings showed to decrease the spread of infectious illnesses [3,7] and reduce absenteeism [3]. This study will use a cluster randomized controlled design which includes larger participants and a long follow-up period. Systems will be installed in all the groups which can provide concrete data on the handwashing activities. Another strength of this study will be assessing the children’s self-reports as there are few interventional studies that measured this. Evaluating the effectiveness of the gamified live feedback intervention will enable the research team to determine if this kind of approach is worth implementing to improve handwashing practices in various settings i.e., clinical, and educational settings.

Limitations

The intervention, technology and experimental setup were evaluated in a pre-study. The pre-study showed promising results with regards to main effects: a statistically significant increase in handwashing time was observed in the treatment kindergarten. Minor issues and challenges that were encountered in the pre-study are considered and improved in the presented study here diminish existing limitations. Especially the technical hardware was improved to diminish the risk of hardware failures and outages. Furthermore, a research member is assigned to address the technical issues during the study immediately, if any issues happen. A possible limitation is the Hawthorne effect when observing the handwashing activity, as individuals might change their behaviour when knowing that they are being observed. To manage this, the observers will not be informed the participants when and where the observation sessions take place, and during the observations, they will be informed that the focus is on hand hygiene in general. Another limitation is the ongoing Covid-19 pandemic, as it can affect the collection of sick leave days for the children and kindergarten staff. To minimize this, sick leave data one year before the baseline phase will be obtained from the record of the kindergarten. Covid-19 also affect the children’s hand hygiene behaviour and performance. Thus, there will be four different groups to be compared in three timepoints and a 12-month follow-up.

Supporting information

S1 Table. SPIRIT checklist.

(PDF)

Click here for additional data file.^{(240.9KB, pdf)}

S1 File. Ethical approval, finland (finnish original version and english translation).

(PDF)

Click here for additional data file.^{(2.6MB, pdf)}

S2 File. Ethical approval, germany (german original version and english translation).

(PDF)

Click here for additional data file.^{(115.6KB, pdf)}

S3 File

(PDF)

Click here for additional data file.^{(475.9KB, pdf)}

Acknowledgments

The authors acknowledge the participating kindergartens in Turku, Finland and Bamberg, Germany for their willingness to take part in this study.

Data Availability

No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.

Funding Statement

Business Finland and the Oras Group partly funded this study. The funders did not influence the study design, data collection, data analysis, decision to publish, or manuscript preparation. No additional external funding was provided for this study. The Grant number of the award is not available. NO.

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PLoS One. doi: 10.1371/journal.pone.0280686.r001

Decision Letter 0

Maiken Pontoppidan

20 Sep 2022

PONE-D-22-16014Hand hygiene of kindergarten children - understanding the effect of live feedback on handwashing behaviour, self-efficacy, and motivation of young children: protocol for a multi-arm cluster randomized controlled trialPLOS ONE

Dear Dr. Dangis,

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Reviewers' comments:

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Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

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Reviewer #1: Yes

Reviewer #2: Yes

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Partly

Reviewer #2: Yes

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: No

Reviewer #2: No

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Reviewer #1: Yes

Reviewer #2: No

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Reviewer #1: Yes

Reviewer #2: Yes

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6. Review Comments to the Author

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(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Thanks for the opportunity to review this trial protocol paper; this seems like an interesting and potential impactful trial. However, I find some aspects of the design and analysis to be quite unclear in the manuscript (and a couple of aspects I find concerning if accurate) and have outlined comments to this effect below:

1. The hypotheses section is unclear as to what comparisons are being made and in what phases of the trial (and this doesn’t appear to be explained elsewhere). I think it is important to pre-state these in a multi-arm trial, if not here, then in the analysis section. For example, for H1, I assume this is a comparison of the A and B groups pooled versus the control group to test superiority of the display intervention over nothing (control) in the intervention phase? H2 is then presumably a comparison of B versus A in the post and long term phase? I suggest making this clearer for all the hypotheses. The hypotheses section also doesn’t seem to mention the intervention C arm at all; I assume this arm is included in some of the comparisons.

2. In the eligibility criteria, it says the criteria will be “children enrolled in the kindergartens aged three to six years old, in single cases 2,5 years old can be included”. I don’t understand the latter part of that sentence, what does “in single cases” mean here? Surely either 2.5 year olds are eligible or they are not?

3. It is stated that the primary outcome is the hand hygiene behaviour of the children but then a number of measures are listed (“It will be measured from the system that will be supported by the parent survey, kindergarten staff interview, and children’s observation session. The system will measure the hand hygiene activities which includes the start time of extraction, water volume, water temperature, and end time of extraction; from these data, the following data will be derived: average flow rates, approximation of energy consumption, quality and duration of handwashing, and time stamp of soap used”). Will these all be reported as separate measures, or is there some composite measure that will be constructed (if so, how?)? I note later in the data analyses section it says “water and soaping data are combined to single handwashing procedures;” but I think needs more clarity as this only seems to cover some of the above mentioned measures.

4. Following on from the previous point, if there are multiple measures for the “primary outcome” and not composite, how are you interpreting these measures? In most trials, you would have a single primary outcome measure which is the most important measure and the headline result as to whether trial shows effectiveness of the intervention. I don’t believe this is always necessary, but I do think your primary outcome and subsequent interpretation needs to be clearer. Are you using a frequentist approach and using p-values to interpret “statistically significant” results (that is my assumption based on your sample size calculation)? If you are, how will you interpret these if some measures are statistically significant (and clinically significant), and some are not? I am not necessarily an advocate of correcting p-values for multiple comparisons, but I think there needs to be some indication of how will interpret these multiple measures as showing whether trial shows effectiveness of the intervention. Is there some hierarchy of which are most important to show benefit?

5. In the sample size section, you say “With a cluster size of 40, this means 3 clusters/kindergartens”. Do you mean 3 clusters of 40 participants per arm? This needs to be made clear. (I assume can’t be 3 clusters total, as you have 4 arms…). I also think you need to state target sample size (participants and clusters) in the abstract.

6. In the randomisation section, you say that “The participants will be allocated randomly to control, intervention A (instruction), intervention B (reward), and intervention C (reward plus instruction) groups”. I don’t understand this – surely it is the clusters that are being randomised and not the participants as you will be applying each intervention to a whole cluster/kindergarten? Please clarify.

7. There needs to be a bit more information about the randomisation algorithm to assure the reader that this process is not biased. How will the researcher randomly assign the clusters (assume it is clusters as per above comment)? Will they write/use an algorithm in some software package, use some online randomisation service/tool? Presumably they will use stratified block randomisation to ensure equal number of clusters across arms/strata?

8. The manuscript says “this study will use double-blinding in which the children, parents, kindergarten staff, and the statistician will be unaware of which group received the content of the intervention”. I don’t understand how it is possible to blind the children and the kindergarten staff, will they not be able to tell based on the installation? For example, your manuscript says that “The control group will have no screen display next to the sink throughout the study.”

9. It is not 100% clear from the data management section how the quantitative hand washing measures will be collated for purpose of data analysis; it says no person-specific data will be collected, presumably this will be anonymised individual data (which can’t be linked to child specific data) or will it be summary data from the cluster? This then affects the quantitative analysis section presumably.

10. The quantitative analysis part of the data analyses section needs more detail. Some of this is because it is not clear what measures form part of the primary outcome or which comparisons are being made (as per previous comments). The protocol doesn’t need to include the full statistical analysis plan, but at minimum I’d expect this section to include the analysis strategy for the primary outcome including the analytic model, which covariates (fixed or random effects) will be included, what groups will be compared at which timepoints and how missing data will be treated.

11. “The intervention groups are Intervention A is the instruction group; Intervention B is the reward group; and Intervention C is the instruction plus reward group”. I find this sentence misleading. The diagram you have provided seems clear, and my understanding is Intervention B does include instructions in the intervention phase but not in the post-phase. I suggest editing this sentence to reflect that.

12. I don’t necessarily agree with the argument that you don’t need a Data Monitoring Committee or other independent oversight, just because there are no perceived safety risks. This is not the only reason to have one; ensuring good study design, good clinical practice and data quality is another. Is there a Trial Steering Committee or other independent oversight? I suggest stating if there is. (If not, I recognise that this is probably not something you can change at this stage).

Reviewer #2: Thank you for the opportunity to review this protocol paper. This is a very important and valuable study understanding the effects of hand washing behaviour of kindergarten children through an intervention of live feedback, observations, and interviews/survey. I would be very interested to hear your study outcomes in the next 12 or so months! While this paper is well written, overall, some areas of the protocol need to be clearer. I have provided some comments that authors might like to consider.

Introduction:

• Paragraphs 2 to 5: suggest rearranging, i.e. start with the importance of education settings for child development (this will link to the first paragraph), then high infectious disease transmission in these educational settings (problem), then the importance of hand hygiene (solution), but how this is difficult to monitor and currently data around this are limited etc.

• Since the theme of your study is based on gamification and feedback (live feedback in particular) I think you need to include current literature on how gaming and feedback can impact change in behaviour.

Methods:

• Objective and Hypotheses

o Unclear in the study how you will measure increase self efficacy and motivation crowding-out

• Hypotheses

o Intervention C seemed to have been left out of this section – this needs to be included in your hypotheses

o Crowding-out – not familiar with this term – can you provide an example and/or more explanation?

• Trial design

o Second paragraph, Line 7, page 7 ‘… Intervention B is the reward group;…’ Doesn’t intervention B include instruction as well as reward, but Intervention C include instructions post intervention?

o Page 8, line 1 ‘… which will receive instructions but no reward.’ Interested to know authors’ thoughts on this – will children be disappointed seeing instructions but receiving no reward? Will this result in the decrease in hand hygiene?

o I’m wondering if a true control would be a group with no screens installed, just the monitor system; would having screens installed have any effects (the very least curiosity in children) on their behaviour?

• Eligibility criteria

o Not sure what ‘2,5 years old’ meant? Is that 2 to 5 years, or 2 and 5? Or do you mean 2.5?

o Unclear who is to give informed consent – children or their parents/guardians? Can a 3 or 4, even 5 yo give informed consent?

o Page 10, line 4 ‘The hand hygiene behaviour of the children will be observed…’ Who will be doing the observation? Will the kindergarten centre staff have time to observe and record their behaviour? How will be observations be recorded?

o Children interviews – can you provide the types of sample questions? These can be quite complex for a 3yo. And will it be a group discussion or a one-on-one interview? How will you engage those ‘shy’ and perhaps non cooperative children? If you ‘exclude’ them, will you be introducing bias in the study?

• Study participants

o You need to explain figure 5 in more detail or move (Fig 5) to a more relevant section. It doesn’t seem to fit currently.

• Sample Size

o You have mentioned a pilot study a couple of times throughout the manuscript; however, you haven’t provided any details. Details and how this study relates to the pilot study is needed to provide context.

o For those who struggles with sample size calculations and just pass this onto their statisticians (�), can you please, in simpler terms, tell us how many in each group i.e how many kindergartens in control/intervention groups (3 each?) and how many children needed to participate in each kindergarten? Will the numbers be similar across groups and within groups? Expected numbers at baseline, dropouts, and minimum numbers needed to provide significance in the study?

• Randomization

o Page 11, paragraph 2: It is important to be consistent when you use the term ‘participants’ – do you mean kindergarten or children? If participants refer to kindergarten, please say that, as participants are usually referred to as individuals. If this is referred to as individuals, i.e. children participating in this study, how will you allocate them randomly in each group at the same kindergarten and monitor them?

o Page 13: as the study is based on the volume or water and soap used and children are not always observed, is it possible for the children to leave the tap running or use a large amount of soap wasted onto the sink without washing their hands? Will that be a limitation?

o Is the purpose for the children to imitate the screen instruction while washing hands?

• Ethics and dissemination

o Page 18, line 3: ‘Consent forma’ should be ‘Consent forms’? �

o In the eligibility criteria section, you mentioned children giving informed consent (see comment above), but here, you say it is decided by parent or legal guardian – can you please make this clearer who is to provide consent, and how is informed consent be given by the children?

• Limitations

o Technical issues are not a limitation of your study design, but a risk that you need to mitigate, and have a backup plan.

o COVID-19 pandemic is a curve ball no one really see coming! In our study, we found that through COVID-19, children have been taught hand washing and hygiene so well, it impacted our study/game design! So COVID-19 is a positive for the children as it increased the hand hygiene knowledge, but not great for us researchers!

• Fig 1

o Your schedule doesn’t include any follow-up except deinstallation of faucets. Will you have 12 month follow up, observation and interviews? Where possible, please include any follow up to measure the effects of your study and whether it sustained the hand hygiene habit in participating children

o Shouldn’t you be including sick leave days at baseline, post interventions and follow up?

**********

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Reviewer #1: No

Reviewer #2: Yes: Ruby Biezen

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PLoS One. 2023 Jan 24;18(1):e0280686. doi: 10.1371/journal.pone.0280686.r002

Author response to Decision Letter 0

16 Nov 2022

Response to the Reviewers on PONE-D-22-16014

Dear Editor and Reviewers,

Thank you for your kind words and insightful review of our submission. We have addressed your important points, comments, and suggestions raised. The responses are documented in the table below.

Academic Editor’s comments and author’s responses:

1. Please include the following items when submitting your revised manuscript:

-A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.

-A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.

-An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

Response: In the current revision, the rebuttal letter was uploaded as a separate file named “Response to Reviewers”. The marked-up copy of the manuscript is also uploaded as a separate file named “Revised Manuscript with Track Changes”. The unmarked version of the revised manuscript without track changes is also uploaded as separate file named “Manuscript”

2. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future.

Response: Thank you for the suggestion. This study is not a laboratory protocol, but rather a study protocol of a cluster randomized controlled trial. Hence, we cannot deposit in protocol.io.

3. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at

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Response: The manuscript has been edited following PLOS ONE’s style requirements, thank you for the comment.

4. We note that you have stated that you will provide repository information for your data at acceptance. Should your manuscript be accepted for publication, we will hold it until you provide the relevant accession numbers or DOIs necessary to access your data. If you wish to make changes to your Data Availability statement, please describe these changes in your cover letter and we will update your Data Availability statement to reflect the information you provide

Response: Thank you for this comment. This manuscript is a study protocol, and we cannot provide repository information. However, we correct this and stated this information in the Data availability statement in the cover letter.

5. Please include your full ethics statement in the ‘Methods’ section of your manuscript file. In your statement, please include the full name of the IRB or ethics committee who approved or waived your study, as well as whether or not you obtained informed written or verbal consent. If consent was waived for your study, please include this information in your statement as well.

Response: Thank you for your comment, the full ethics statement in the method section and the full name of the ethics committees are included in the manuscript. Informed written consent from the parents and kindergarten staff will be obtained and verbal consent will be obtained from the children. These statements have been added in the ethical considerations section which can be found on pages 19 and 20.

6. We note that the original protocol that you have uploaded as a Supporting Information file contains an institutional logo. As this logo is likely copyrighted, we ask that you please remove it from this file and upload an updated version upon resubmission.

Response: This was left unnoticed, thank you for your comment. The institutional logos in the supporting information files are deleted.

Comments from Reviewers 1 and 2:

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

Response: Thank you for the kind words, I hope that the revised manuscript is even better.

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

Reviewer #1: Partly

Reviewer #2: Yes

Response: I acknowledge that there are sections in the manuscript which have insufficient details and some sections especially in statistical analyses should have been described clearly. The comments of the editor and the reviewers are addressed accordingly, and the responses are found below.

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Reviewer #1: No

Reviewer #2: No

Response: Agreed. The methodology has insufficient details and is not described clearly. The editor’s and reviewers’ comments and suggestions are considered. In the current revision, the important points that were raised have been corrected and explained clearly.

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

Reviewer #1: Yes

Reviewer #2: No

Response: Thank you. The manuscript has been edited and provided sufficient details. I hope that the current revision is better organized.

5. Is the manuscript presented in an intelligible fashion and written in standard English?

Reviewer #1: Yes

Reviewer #2: Yes

Response: Thank you, the current version has been checked and edited for any typographical or grammatical errors using grammar software.

6. Review Comments to the Author:

Reviewer #1 comments:

Response: Indeed, the intervention C group was missing in the hypotheses section. We also added the comparisons of the four groups (control and intervention groups A, B, and C) at different timepoints (baseline, intervention, post-intervention phase and follow-up in Finland). This section can be found on pages 6 and 7.

Response: Yes, you are right this statement could have been made clearer. Children aged two years and six months old are eligible to participate in the study. This has been edited. This section can be found on page 10.

Response: Thank you for the in-depth analysis of this part. The team considered your comments, and we decided that there will be only one measurement for the primary outcome which will be the data from the system. In addition, the other measurements that will be used in the secondary and tertiary outcomes will also give support to the primary outcome’s result. This section can be found on pages 10 and 11 in the outcome measures section.

Response: Yes, thank you for the detailed explanation of the statistical analysis. As the team decided, we will only use one measurement for the primary outcome which will be the data from the system. There will also be five secondary outcomes: (1) Self-efficacy – children’s one-on-one interview after baseline, intervention, and post-intervention, (2) intrinsic motivation – children’s one-on-one interview after baseline, intervention, and post-intervention, (3) hand hygiene behaviour at home – parent’s survey after intervention phase, (4) hand hygiene behaviour in kindergarten based on kindergarten staff – kindergarten staff interview after intervention phase, (5) hand hygiene behaviour based on direct observation – research member’s observation sessions after baseline, intervention, and post-intervention. The tertiary outcome will be the same, sick leave absences comparing one year before and after the baseline phase. This section can be found on pages 10 and 11.

Response: We agree with you that this statement should have been made clearer. Since the sample size needed is 106 children, there will be 3 clusters with a size of 40 children, of which one cluster will be divided into two intervention arms. Hence, the number size of the two intervention arms will be 20 children. The other two groups control and one intervention group will consist of 40 children. A detailed explanation can be found on page 12. We also added the target sample size in the abstract section on page 3.

Response: Agreed. This statement needs to be corrected. The correct statement is that the kindergartens will be randomised to control and to three intervention groups. This section can be found on page 13.

Response: Thank you for pointing this out, we agree that we have not stated the details of the randomization process in the manuscript. The team decided to use simple randomization by drawing lots. Where each cluster will be given a number written on a small piece of paper which will be folded. The two personnel who will not be part of the team will be the ones to conduct the randomization. This section can be found on page 13 in the randomization section.

Response: Thank you for your comment. The statement could have been explained clearly. The study will use double-blinding however, a more detailed statement could have been added. The content of the informational letter to be dispersed to children, parents, and kindergarten staff will be only the faucet and the system that collects data. The live feedback display will not be mentioned. The children and the staff will be unaware if they are receiving the intervention or not. This section can be found on page 13 in the blinding section.

Response: This section would have been made clearer. It is correct that the collection of data will be done anonymously However, since this study will be a cluster randomized trial, the data collected will be the summary data for each arm. This statement is added and can be found on page 18.

Response: As we have decided that we will use one measure for the primary outcome (data from the system). The outcomes will be compared among the groups in three timepoints which will be after the baseline, intervention, and post-intervention phases. Statements are also added regarding the analysis. This section can be found on pages 17 and 18.

Response: Indeed, this statement is misleading. This was left unnoticed. The intervention B and C groups will receive instruction plus a reward in the intervention phase and during the post-intervention phase, the intervention C group will receive instructions. The statement has been corrected and it’s found on page 8 in the trial design section and page 15 in the implementation section.

Response: Yes, we agree with you, this part should be explained clearer. This study will not have Data Monitoring Committee or Trial Steering Committee. This behavioural intervention poses a very low risk, it does not require trial steering or data monitoring committee (Sydes 2004). This section can be found on page 19.

Reviewer #2 comments:

1. Introduction:

Response: Thank you for your comments and suggestions. We have made changes according to your suggestions and added statements about the importance of hand hygiene. This can be found on pages 4 – 6.

Since the theme of your study is based on gamification and feedback (live feedback in particular) I think you need to include current literature on how gaming and feedback can impact change in behaviour.

Response: We agree with you that gamification and feedback should be added in the introduction part. We have added one paragraph regarding this. This can be found on page 5 in the introduction section.

2. Methods:

• Objective and Hypotheses

o Unclear in the study how you will measure increase self efficacy and motivation crowding-out

Response: Thank you for noticing this. Statements are added for further details on how to measure the self-efficacy level and motivation crowding out. The measurements for these will be children’s one-on-one interviews done by the assistant researchers. The children will answer by pointing out their answer from the three smiley faces (sad, neutral, and happy) then after will be followed by open-ended questions. This can be found in the outcome measures section on pages 10 and 11.

3. Hypotheses

o Intervention C seemed to have been left out of this section – this needs to be included in your hypotheses

Response: This part was left unnoticed, thank you for the comment. Intervention C was included in the hypotheses section which can be found on pages 6 and 7.

4. Crowding-out – not familiar with this term – can you provide an example and/or more explanation?

Response: Thank you for the comment. According to Gagner 2014, crowding out is an effect where there is a decrease or lack of motivation to perform a task because the reward is already known or expected. A brief statement is added in the objectives and hypotheses section on page 6.

5. Trial design

Response: Agreed, this was left unnoticed. It is correct that interventions B and C included instruction plus reward in the intervention phase and during the post-intervention phase intervention C includes instructions. This part has been corrected and it can be found on pages 8 and 9.

6. Page 8, line 1 ‘… which will receive instructions but no reward.’ Interested to know authors’ thoughts on this – will children be disappointed seeing instructions but receiving no reward? Will this result in the decrease in hand hygiene?

Response: Thank you, you made a good point on this. This is one part we wanted to investigate in this study if receiving instructions plus a reward is more effective in hand hygiene than receiving only instructions. Also, in the informational letters, the feedback display will not be mentioned, and the participants will not know about it until the intervention phase. This statement is added on page 13 in the blinding section.

7. I’m wondering if a true control would be a group with no screens installed, just the monitor system; would having screens installed have any effects (the very least curiosity in children) on their behaviour?

Response: A very good point on this but since the feedback display is not mentioned in the informational letter then the children in the control group would not have known that there will be a real-time feedback display. This statement is added in the blinding section in page 13. Installing the display without any activity in the control group might affect the children’s behaviour, but unfortunately this will not be investigated in this study.

8. Eligibility criteria

o Not sure what ‘2,5 years old’ meant? Is that 2 to 5 years, or 2 and 5? Or do you mean 2.5?

Response: You are right this statement could have been made clearer. So, children aged two years and six months old are eligible to participate in the study. This has been edited. This section can be found on page 10.

9. Unclear who is to give informed consent – children or their parents/guardians? Can a 3 or 4, even 5 yo give informed consent?

Response: We agree that this section could have been explained more clearly. The study will be explained to the children in a manner that they can understand, and they will be asked if they want to participate in the study. Children will provide verbal consent if they want to participate or not, but it is the parent’s decision if they want their children to participate in the study or not. This statement can be found on page 10 in the eligibility criteria section and pages 19 and 20 in the ethical considerations section.

10. Page 10, line 4 ‘The hand hygiene behaviour of the children will be observed…’ Who will be doing the observation? Will the kindergarten centre staff have time to observe and record their behaviour? How will be observations be recorded?

Response: Thank you for asking about this part. We acknowledge that we have not provided complete details about the observation. Assistant researchers will be hired to interact with the children, parents, and kindergarten staff. They will do the observations at the last week of each phase. And due to the limited resources, video recording cannot be realized. This section can be found on pages 10 and 11 in the outcome measures section.

11. Children interviews – can you provide the types of sample questions? These can be quite complex for a 3yo. And will it be a group discussion or a one-on-one interview? How will you engage those ‘shy’ and perhaps non cooperative children? If you ‘exclude’ them, will you be introducing bias in the study?

Response: Thank you for having an interest in the children’s questions. It will be a one-on-one interview; we also have provided further details in the manuscript. These interview questions will be short, and easy to understand, and questions will be pre-tested. During the interview, the interviewer will introduce herself/himself first and ask simple questions regarding their day or regular activities. Simple instructions and a sample question will be given for the children to feel comfortable. This part can be found on pages 10 and 11.

●Sample questions: (1) Do you think that you can wash your hands properly? (2) Do you like washing your hands? (3) Do you feel like it is easy to wash your hands?

For shy children, assistant researchers will try their best to let them participate in the study. But in case there will be non-cooperative children, they can be excluded. In these types of cases, researchers cannot intervene more, hence we acknowledge that bias will exist.

12. Study participants

o You need to explain figure 5 in more detail or move (Fig 5) to a more relevant section. It doesn’t seem to fit currently.

Response: Indeed. Figure 5 has been moved to a more relevant section which can be found on page 15 in the implementation section. The figure is updated to figure 8, a flowchart of the cluster randomization.

13. Sample Size

Response: Agreed. Thank you for your comment. This was corrected to a pre-study. A brief statement has been added regarding the pre-study and can be found on page 12 in the sample size section and pages 21, and 22 in the limitations section.

14. For those who struggles with sample size calculations and just pass this onto their statisticians (�), can you please, in simpler terms, tell us how many in each group i.e how many kindergartens in control/intervention groups (3 each?) and how many children needed to participate in each kindergarten? Will the numbers be similar across groups and within groups? Expected numbers at baseline, dropouts, and minimum numbers needed to provide significance in the study?

Response: Thank you for your comment. Since we based the sample size calculation on a pre-study, we must provide statistical figures. But we agree that this could have been explained in a clearer way. The calculated sample size will be 106 participants so there will be total of 3 clusters with a size of 40 children, of which one cluster will be divided into two intervention arms (Intervention B and C). These two interventions will be having instructions plus a reward during the intervention phase but during the post-intervention phase, intervention C will remain to have the instructions. Hence, the number size of the two intervention arms will be 20 children. This can be found on page 12.

15. Randomization

Response: Thank you for pointing this out, it really is important to be consistent with the term use. This statement has been corrected. The kindergartens will be randomized to control and intervention groups. This can be found on page 13.

16. Page 13: as the study is based on the volume or water and soap used and children are not always observed, is it possible for the children to leave the tap running or use a large amount of soap wasted onto the sink without washing their hands? Will that be a limitation?

Response: This is an interesting question. The faucets and soap dispensers are installed with sensors. The children can play and use a large amount of water or soap wasted onto the sink without washing their hands, but this can happen with a very small chance. Sinks are available in most kindergarten rooms where they can wash their hands aside from the toilets. In the toilets, kindergarten staff (preschool assistants) usually are on watch to help the children when needed.

17. Is the purpose for the children to imitate the screen instruction while washing hands?

Response: Thank you for your comment. Yes, the purpose is for the children to imitate the handwashing instructions during the handwashing activity. This statement is included and can be found on pages 13 and 14 in the intervention development section.

18. Ethics and dissemination

o Page 18, line 3: ‘Consent forma’ should be ‘Consent forms’?

Response: Thank you for noticing it. The typo error has been corrected.

19. In the eligibility criteria section, you mentioned children giving informed consent (see comment above), but here, you say it is decided by parent or legal guardian – can you please make this clearer who is to provide consent, and how is informed consent be given by the children?

Response: Thank you for your comment. We made corrections on this part to make it clearer. The children will be informed and explained about the upcoming study in an understandable manner. They will provide verbal consent to participate, however, it is the parents who will decide their participation. This part can be found on pages 10 in the eligibility criteria and pages 19 and 20 in the ethical considerations section.

20. Limitations

o Technical issues are not a limitation of your study design, but a risk that you need to mitigate, and have a backup plan.

Response: Thank you for correcting this statement, we considered your comment. We corrected and added statements regarding this. The backup plan for these technical issues would be to have spares of the hardware and a research member be assigned to address the technical issues whenever needed. This part can be found on pages 21 and 22.

21. COVID-19 pandemic is a curve ball no one really see coming! In our study, we found that through COVID-19, children have been taught hand washing and hygiene so well, it impacted our study/game design! So COVID-19 is a positive for the children as it increased the hand hygiene knowledge, but not great for us researchers!

Response: This is exactly true. This can be a limitation, but it is not always the case for very young children, they maybe have been taught handwashing and have the knowledge of why to wash their hands, but they may still not know the proper way to wash their hands.

22. Fig 1

o Your schedule doesn’t include any follow-up except the deinstallation of faucets. Will you have 12 month follow up, observation and interviews? Where possible, please include any follow up to measure the effects of your study and whether it sustained the hand hygiene habit in participating children

Response: Thank you for your suggestions. Including a 12-month follow-up for observation and interviews would be very helpful in our study. However, due to limited resources (financially), no other follow-up measurements will be conducted aside from the collection of sick leave absences.

23. Shouldn’t you be including sick leave days at baseline, post interventions and follow up?

Response: Thank you for your comment. Statement is added, the sick leave days are collected one year before and after the start of the baseline phase. This statement has been edited to be clearer which can be found on page 18 in the data collection part.

Attachment

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PLoS One. doi: 10.1371/journal.pone.0280686.r003

Decision Letter 1

Maiken Pontoppidan

6 Jan 2023

Hand hygiene of kindergarten children - understanding the effect of live feedback on handwashing behaviour, self-efficacy, and motivation of young children: protocol for a multi-arm cluster randomized controlled trial

PONE-D-22-16014R1

Dear Dr. Dangis,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Maiken Pontoppidan

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Congratulations! The paper is much improved and is now ready for publication.

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

Reviewer #1: Yes

Reviewer #2: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

Reviewer #1: Yes

Reviewer #2: Yes

**********

6. Review Comments to the Author

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Thanks to the authors for addressing my concerns and making clarifications in the manuscript. I am happy that all of my comments have been addressed and I have no further comments.

Reviewer #2: Thank you for the opportunity to review this manuscript revision. As mentioned in the first review, this is a very important study; the authors have now done a great job addressing the reviewers comments. I am satisfied that my concerns have been addressed appropriately.

My only comment/feedback is Figure 2, the design and data collection of the study. The figure is set out like a timeline, but of course, this is not proportional. It will be good to see the study designed displayed in another way or in a proportional timeline if possible.

Good luck with your study and would love to read the outcome when available!

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: Yes: Ruby Biezen

**********

PLoS One. doi: 10.1371/journal.pone.0280686.r004

Acceptance letter

Maiken Pontoppidan

16 Jan 2023

PONE-D-22-16014R1

Dear Dr. Dangis:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Maiken Pontoppidan

Academic Editor

PLOS ONE

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

S1 Table. SPIRIT checklist.

(PDF)

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S1 File. Ethical approval, finland (finnish original version and english translation).

(PDF)

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S2 File. Ethical approval, germany (german original version and english translation).

(PDF)

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S3 File

(PDF)

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Attachment

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Data Availability Statement

No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.

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PERMALINK

Hand hygiene of kindergarten children—Understanding the effect of live feedback on handwashing behaviour, self-efficacy, and motivation of young children: Protocol for a multi-arm cluster randomized controlled trial

Glenda Dangis

Kirsi Terho

Joanna Graichen

Sebastian A Günther

Riitta Rosio

Sanna Salanterä

Thorsten Staake

Carlo Stingl

Anni Pakarinen

Roles

Abstract

Introduction

Methods

Aim of the study

Objective and Hypotheses

Hypotheses

Trial design

Fig 1. Schedule of enrolment, intervention, and assessments.

Fig 2. The design and data collection of the study.

Theoretical framework

Fig 3. Illustration of the reciprocity of the factors determining hand hygiene behavior.

Fig 4. The application of the SCT using the live feedback intervention.

Study setting

Eligibility criteria

Outcome measures

Study participants

Sample size

Recruitment

Randomization

Blinding

Intervention development

Fig 5. Technical setup of the system.

Fig 6. The “How to handwash” content of the video on the screen display.

Fig 7. The animal animation as a reward.

Implementation

Fig 8. Flowchart of the cluster randomization.

Data collection

Data analyses

Data management

Data monitoring

Auditing

Access to data

Ethical considerations

Dissemination and protocol amendments

Discussion

Limitations

Supporting information

Acknowledgments

Data Availability

Funding Statement

References

Decision Letter 0

Maiken Pontoppidan

Roles

Author response to Decision Letter 0

Decision Letter 1

Maiken Pontoppidan

Roles

Acceptance letter

Maiken Pontoppidan

Roles

Associated Data

Supplementary Materials

Data Availability Statement

ACTIONS

PERMALINK

RESOURCES

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