Understanding the relationship between child stimulation and brain function using neuroimaging techniques and behavioral measures: a study protocol

Abstract

Background

Cognitively stimulating environments are known to promote the intellectual, socio-emotional and language development of children. Little is known about the relation between cognition and brain structure in young children in low- and middle-income countries (LMICs), particularly in sub-Saharan Africa (SSA) where children are at risk of developmental delay. The overall objective of this study is to measure the association between child stimulation and brain function using neuroimaging techniques and neuropsychological measures.

Methods

The study will employ an observational follow-up design using a mixed-methods approach. Caregiver-child interaction profiles, children’s developmental scores (N = 980 children) and low-field magnetic resonance imaging (MRI) data (n = 343 children) will be analyzed to understand the relationship between stimulation, developmental outcomes, and brain structure. Associations among the various outcomes will be examined using univariable and multivariable linear regression adjusting for potential confounding factors.

Conclusion

The findings are expected to provide evidence on the association of the quality, extent and frequency of caregiver-child interactions (child stimulation) and child development with brain structure. The evidence generated will inform policy and practice in the childcare sector. Support, investments or revision of policies and practices will be needed to strengthen the quality of childcare in center-based care.

Trial registration

The study was registered under PACTR202408640904874 on 27th August 2024.

Background

The early years of a child’s life are marked by rapid brain development, shaping future educational, behavioral, and economic outcomes [1]. A cognitively stimulating environment - especially one with responsive caregiving - plays a vital role in fostering children’s intellectual, socio-emotional and language development. On the other hand, children’s cognitive development may be affected by biological [2], socio-economic [3], environmental [4], and psychosocial risk factors [5]. For instance, children who are exposed to suboptimal environments may not achieve their full developmental potential and may be less likely to enroll in and complete primary school [6]. In turn, these educational disadvantages may have long-term adverse effects on future outcomes in adulthood and result in lower incomes, high fertility rates, and sub-optimal care for their own children [7]. Further, evidence suggests that socioeconomically disadvantaged children tend to experience less stimulation from their caregivers and may report more stressful events than those from higher socio-economic status (SES) homes which may influence brain structure [8, 9]. It is important to note that long-standing cultural traditions and beliefs may discourage verbal engagement between caregivers and their young children [10]. Caregiver or parenting interventions, particularly those that promote nurturing care and optimal learning environments may mitigate the effects of early risk including exposure to adverse environments and positively influence development in children [11].

There is increasing appreciation of the clinical value of neuroimaging in low- and middle-income countries (LMICs) [12]. However, there is a dearth of imaging studies on cognition among young children in these settings [13], particularly in SSA where children are most at risk of developmental delays [14]. Available evidence on developmental effects of stimulation and other exposures is mainly based on studies that have used neuropsychological measures of cognitive function (e.g., Barros, Matijasevich [15–17]. Few studies have examined the direct relationships between child stimulation and brain function using neuroimaging approaches [18–20]. The use of imaging studies is particularly important in sub-Saharan African contexts where the neurological ramifications of the multiple risk factors that children are exposed to have not been well studied. It is also critical to ensure that participants are well informed about the study procedures that they will be subjected to, as this is likely to impact the feasibility and acceptability of the study. For example, a study conducted in Ghana revealed that most respondents were informed about magnetic resonance imaging (MRI) procedures by family and friends instead of their healthcare providers. Most of these families and friends were not necessarily as qualified as health personnel to sensitize others about the medical value of MRI which may explain the misconceptions participants had about the utility of MRI procedures [21]. The use of “cultural informants” such as family members or respected members of the community in determining what is culturally meaningful is also important.

MRI has significantly advanced our understanding of brain development by mapping structural, functional, and metabolic patterns. These insights have been crucial in identifying alterations linked to neurological, psychiatric, and intellectual disorders while also highlighting the impact of genomic, nutritional, and environmental factors [18]. Neuroimaging techniques can advance knowledge in the discipline of cognitive neuroscience which is mainly concerned with the factors (particularly the effects of a child’s environment and their early-life experiences) that shape the development of the brain [22]. However, despite its immense value, access to MRI remains a major challenge, particularly in LMICs, where approximately 70% of the global population has little or no access to this technology [23].

Deoni and colleagues [18] note that infrastructure demands, prohibitive costs of and specialized training required for MRI may limit its feasibility in resource-constrained settings, resulting in reduced participant numbers and restricted research scope. To address these challenges, researchers advocate for low-field strength systems that are more affordable and adaptable. These systems have cheaper component prices; reduced power, cooling, and maintenance costs; more portability; and smaller room requirements, making them particularly suited for settings with unreliable power supply, or limited resources for room modifications [24]. Portable MRI technology will play an important role in increasing the use of these techniques to track structural changes in the brain as young children develop and provide information that enhances the development of early and targeted interventions. Facilitating MRI research can improve understanding of brain development in the early years and help to create reliable and generalizable measurements of childhood development [25]. However, as noted by Abate and colleagues [12], “while brain imaging does not require cultural or language translation and may be sensitive to neurodevelopmental differences associated with cultural context and the social environment, even the most portable and user-friendly neuroimaging methods are inherently limited in scalability.”

Undertaking neuroimaging scans of young children may be challenging due to several factors including negative perceptions [26], community resistance, and limited cooperation and movement during the process (especially in children) [27]. Given these challenges, it is therefore important to incorporate contextual considerations when implementing MRI procedures. For instance, in many African settings, communities may place high value on a child’s obedience. As noted by Jasińska & Guei [28], in such situations, children may assent to participate in a study despite their unwillingness to do so because of cultural expectations. To address this, researchers should adopt a child-friendly approach that incorporates play in order to maximize comfort, enhance acclimatization to unfamiliar surroundings, put children at ease and reduce anxiety [29].

Wedderburn and colleagues [30] demonstrated the feasibility of undertaking neuroimaging scans during natural sleep without sedation or anesthesia by utilizing behavioral and play therapy techniques. This method is particularly beneficial in pediatric neuroimaging, where the ability to remain still is crucial for obtaining high-quality images. Careful preparation and engagement with participants can further reduce anxiety and increase willingness to undergo imaging procedures. Effective communication is another critical factor in ensuring acceptance of neuroimaging techniques. Misunderstandings about MRI procedures often stem from complex medical terminology that is not easily comprehensible to the public. Researchers must ensure that technical language is simplified and clearly translated for participants and community members, fostering greater understanding and reducing apprehension. Additionally, communities should be actively engaged in discussions to dispel myths and misconceptions surrounding neuroimaging, ensuring that those who participate do not experience stigma [30]. Context-specific engagement strategies, such as partnering with trusted community leaders, can aid in this effort.

Recent advances in noninvasive brain imaging techniques have improved our ability to link specific cognitive functions to changes in brain structure and function in healthy infants and children. Brain imaging techniques also provide a more subtle and sophisticated approach to assess finer grained differences in brain development at the structural and functional levels. Furthermore, neuroimaging enables the investigation of brain plasticity during the early years when the brain develops most rapidly and can reveal how future skills evolve [31]. These techniques have the advantage of enabling more direct examination of the brain, with less noise and confounding from environmental conditions which behavioral measures usually suffer from. A combination of neuroimaging methods and neuropsychological measures can advance our understanding of brain-behavior relations and identify the role that specific interventions have on childhood development [32].

The impact of various biological and social exposures has been extensively examined among populations in LMICs. However, evidence of the association between the quality and quantity of caregiver-child interaction and children's brain development has yet to be examined in LMICs where culture and other unique background factors may modify the association. We cannot rely on evidence from high-income countries (HICs) where these factors differ in scope and magnitude. Further, the relationship between caregiver-child interaction and child outcomes in the context of multiple risks has mostly been measured using neuropsychological measures of development and functional imaging methods [18] despite their pitfalls. One of the concerns with using behavioral measures is that they are particularly prone to effects of various confounding factors such as SES. Neuropsychological measures also only show whether a child can perform a specific task but do not reveal the mechanisms and processes involved in the acquisition of specific skills. The use of neuroimaging techniques minimizes the effects of external factors and data from such an approach are also critical in revealing the neural processes that occur in performance of various tasks. However, one consideration is that brain measurement using neuroimaging in young children requires minimal body movement which can be difficult to achieve with young children compared to adults [20].

Our conceptual framework posits that a child’s early experiences are embedded within the caregiving environment. The interactions between the caregiver and the child contribute to specific changes in brain structure and function. Given that the basic wiring of the brain is already established by the time a child is born [33], early experiences further refine these primary circuits to become more efficient, with gradual improvement of other functional networks supporting various developmental functions [34]. For instance, high caregiver sensitivity has been associated with increased functional connectivity between those regions in the brain that are involved in emotion regulation, cognition, and communication [35]. On the other hand, adverse patterns of social experiences are associated with structural and functional brain atypicalities [36]. Caregiver positive affect during interactions with children is also associated with connectivity between different parts of the brain [37]. Children’s own behaviors also influence the interaction with the caregiver and how the caregiver behaves in turn [38]. Ultimately, the interactions are expected to improve the early childhood development (ECD) outcomes for young children living in informal settlements.

Our study therefore seeks to investigate the role of caregiver-child interaction and stimulation on child developmental outcomes (across the five domains) and brain development among infants attending childcare centers or being cared for at home. We will use low-field neuroimaging techniques alongside neuropsychological measures to assess the outcomes of interest. This project will also add to the existing knowledge on the relationship between childcare and brain development and structure using neuroimaging techniques. The specific objectives of this study are: (1) To understand community perceptions and acceptability towards brain imaging techniques for assessing child cognitive function and brain structure; (2) To profile the child stimulation provided through the interactions that children have with center caregivers in childcare centers in informal settlements and with their caregivers at home; (3) To examine the association between caregiver-child interactions and cognitive scores and school readiness using behavioral measures of child development and learning; (4) To examine the association between caregiver-child interactions and brain activity using brain imaging techniques; and (5) To examine the associations between cognitive/school readiness scores and brain structure as measured by MRI techniques.

Methods

Study design

The study will employ an observational prospective cohort/follow-up design with a mixed methods approach to examine the relationship between caregiver-child interactions, child development and brain function. A total of 980 children aged 0–3 years attending childcare centers or receiving care at home in informal settlements will be recruited. A sub-sample of 343 children will be randomly selected for neuroimaging assessments using low-field MRI scanners.

Study population and eligibility criteria

Our study population consists of children aged 0–3 years and their caregivers. Participants must meet the following inclusion criteria: the child and caregiver must be long-term residents of an urban informal settlement; childcare must be provided either in a childcare facility or at home; the caregiver must be willing to participate in the study. All participants who do not meet these criteria will be excluded. Children with neurodevelopmental disabilities (e.g., cerebral palsy or autism) will be included in the study but excluded from MRI scans due to the potential challenges in following instructions or remaining still during the imaging procedures.

Sample size calculation

The main outcome of this study is child development quantified using the Global Scales for Early Development (GSED; 39) score. In calculating the sample size for this study, the study assumes a confidence interval of 95%; a margin-of-error of 5%; statistical power of 80% (to reduce the likelihood of false negatives); a minimum detectable effect size (ES) of 0.2 (to raise a sufficient sample size for detecting tiny differences, as opposed to the requirement of small sample size when effect sizes are large); and a 20% attrition rate (to account for participant dropouts). Therefore, the required sample size will be estimated as follows:

1

Where;

is the sample size unadjusted for attrition

is the critical value of the standard normal distribution corresponding to . Setting , then = 1.96

is the critical value of the standard normal distribution corresponding to (power). Setting power to 80% then 0.84

is the minimum detectable effect size. We assumed an ES of 0.2.

Fixing the above information to Eq. (1) yields:

Accounting for an attrition rate of 20%, then:

Hence, we will recruit 490 children in each of the two study groups (childcare setting and homecare setting). Thus, a total of 980 children aged 0–3 years whose parents are willing to participate in the study will be recruited and followed up over a period of two years or until school entry.

For the neuroimaging study, we will adopt a consecutive sampling approach where we will recruit only participants who explicitly consent to participate. The sample for the neuroimaging study will be drawn from the main sample. About 343 children (229 from childcare centers and 114 from homecare settings) from two counties (Nairobi City and Kisumu) will be randomly selected and invited to participate in the neuroimaging study. We expect to complete the recruitment process by 15th July 2025.

We will randomly select the facilities from a sampling frame of all childcare facilities in the study areas and allocate the number of participants proportionately in the two counties. Within the centers selected for inclusion into the study across the two counties, we will recruit consecutively until the target sample size is achieved.

Study outcomes

The primary outcomes for this study focus on neurodevelopmental outcomes and neuroimaging findings, aiming to assess how early stimulation influences brain structure and function. These measures will provide critical insights into the relationship between caregiver-child interactions and cognitive development. The secondary outcomes include school readiness scores which will help determine how early cognitive stimulation affects children’s preparedness for formal education. Additionally, the study will examine negative deviance / resilience as a secondary outcome. While a positive correlation between stimulation and cognitive scores is expected, we are particularly interested in cases where children exhibit high developmental scores despite low stimulation levels. Identifying such instances will provide valuable insights into resilience factors that enable children to thrive despite limited environmental stimulation.

Study site

The study will take place in informal settlements within two counties (Nairobi City and Kisumu) in Kenya. These counties have been purposely selected because we and our partners have previously had research projects on childcare in these counties. We are therefore familiar with the settings based on prior experience, and we will leverage the established community relationships. There is a high demand for childcare services in the informal settlements, making these communities ideal for studying early stimulation and development.

The informal settlements in Ruaraka sub-County in Nairobi City County, and Nyalenda, Arina, Obunga, and Manyatta in Kisumu County have been selected as they are in close proximity to where the MRI machines are located ensuring accessibility for participants. Finally, we selected the communities within the informal settlements in these two counties because these populations face the greatest challenge of suboptimal parenting care and child development and they are most likely to benefit from this study.

Data collection tools and procedures

At the onset of this work, we will carry out a rapid review to synthesize results from relevant research studies to understand existing evidence with regards to child stimulation and development and links to imaging profiles.

Qualitative data component

Perceptions to MRI approaches

Before conducting any interviews, we will have engagements at the community level to understand community attitudes to, experiences and perceptions of neuroimaging approaches. Community sensitization sessions in Nairobi City and Kisumu Counties will be led by key community opinion leaders, selected representatives of the policy makers and implementers, and the research team, with. We intend to employ culturally relevant awareness and sensitization avenues such as community dialogues and perform a mock MRI scan with a few participants so that they familiarize themselves with the procedure before the actual scans are done. Further, we will consult community gatekeepers and ensure that all community entry and sensitization activities are aligned with the communities’ aspirations and norms. We will purposefully map out the venues for sensitization through consulting the community leaders within all the informal settlements in the study sites. Whereas our research team will be present to respond to the questions about the use of neuroimaging techniques, we will ensure the radiologists are also present to provide responses to some of the technical questions on the use of these techniques and the safety considerations.

Participants for the qualitative interviews will be selected purposively. We will conduct 4–6 focus group discussions (FGDs) in venues that are accessible to the participants and free from external distraction. The FGDs will each include about 6–8 participants. We will stratify the study participants into different participant groups – mothers, fathers, and childcare center providers – to delineate their understanding and knowledge of, attitudes towards, and previous experiences with the use of low-field MRI procedures. We will interview 6–8 sub-county and county officials and policy implementers using key informant interviews (KIIs). We anticipate that these numbers will be adequate, and will adjust them depending on when saturation on key emerging themes is achieved.

Quantitative data component

Demographic and medical history data

Sociodemographic data will be captured at baseline through interviews with mothers and childcare providers using validated questionnaires. Measures of socioeconomic status will be used to capture information on income, education, marital status, occupation and use of childcare services. Information on child age, gender, medical history and schooling will also be collected. We will also capture information on household assets which will be used to develop a household wealth index.

Caregiver-child interactions

We will assess caregiver–child interactions using the Caregiver Interaction Profile (CIP) [40] or the Infant-Toddler Environment Rating Scale (ITERS) [41]. ITERS scores the number of times a particular behavior with the child happens. Whereas past studies in high-income settings have shown that the ITERS-R and CIP are appropriate tools to use in examining childcare provider-child interactions (e.g., 40), it is important to recognize the need for tailoring an assessment for a particular context. We will minimize cultural bias in the testing materials by ensuring that the test items assess stimulation practices that are meaningful to the population under study. We will also ensure that the observations are made objectively based on the context of the community.

We will use the Language ENvironment Analysis (LENA) System to record verbal interactions (communication) between the caregiver and child. The LENA has been validated and used extensively in studies in low-income contexts to show variance in child language output based on various factors [42]. We assume that use of the CIP, ITERS and LENA tools will minimize the Hawthorne effect across the measures.

Developmental and school readiness assessments

Developmental outcomes will be measured using the GSED [39] and the Communicative Development Inventory (CDI; 43) specifically for assessing language development. School readiness will be assessed using the Measurement of Early Learning and Quality Outcomes (MELQO) [44] tool. All the child assessments will be conducted at the baseline during the initial recruitment of the study participants, midline (about nine months after the baseline data collection) and endline (about 18 months after the baseline data collection). In SSA, the GSED was initially validated in Tanzania as a metric that countries with similar contexts could use to track progress of child development among populations of young children [39]. The validation was conducted in six countries outside Africa with multiple linguistic, cultural, and socio-economic backgrounds [39]. The reliability and validity of the CDI have been established among populations in contexts where children have multiple caregivers and where respondents have low literacy levels [43]. The MELQO was developed specifically for low- and middle-income settings and its psychometric properties are well established.

Neuroimaging

The neuroimaging procedures will be done using portable (field type) low-field MRI scanners. We will identify suitable locations for the MRI procedures within the field. The assessments will be done at the centers or any other suitable locations within the communities, at recruitment (baseline), and bi-annually over the course of the two years of the study implementation period. The scanning procedures will take approximately 30 min to complete. We have developed a manual of standard operating procedures to ensure standardization of the process.

Recruitment and training of the field team

Data collection will be done by a team of field interviewers who will be recruited from the target communities. The field interviewers will be those who have a bachelor’s degree and experience in conducting quantitative and qualitative interviews. They will be trained in administering the tools and will be supervised by the Research Officer and the Project Manager.

Prior to the data collection, a quick pilot of the tools will be done in the two counties and necessary modifications to the tools or their administration effected. We will ensure that all the study participants taking part in the pilot exercise are consented prior to engagement. For the qualitative component of the pilot testing, we will engage about eight mothers, eight fathers, and eight center providers in each county. For the quantitative component, we will engage about 30 participants, 15 from each study county. We will triangulate our results using different tools concurrently to measure child outcomes. The pilot testing will enable us to validate and make cultural adaptations to our tools to ensure that they are meaningful for use among populations living in informal settlements. We will make the necessary modifications to the study tools after the pilot to align with the research questions.

Data processing and analysis

Analytical plan and data management plan

First, we will describe the MRI scan success rate using the procedure outlined by Wedderburn and colleagues [30]. Scan success will be categorized as a full scan, part successful scan or no scan. We will measure associations between scan success and children’s developmental scores, age and sex using Analysis of Variance (ANOVA)/Chi-square test depending on the variable type. In line with APHRC’s data protection and privacy policy, we will destroy any records of participants who may wish to withdraw their participation after the study has commenced. All incomplete data from unsuccessful MRI scans will be scrutinized for quality by our data team and the radiologists and an appropriate decision will be made on a case-by-case basis.

Caregiver-child interactions will be used as the proxy for child stimulation and will be summarized using means and standard deviations. Developmental scores will be calculated as standardized domain scores and described using means and standard deviations. Similarly, MRI profiles will be standardized and described using means and standard deviations.

We will examine correlations between caregiver-child interaction and developmental scores, followed by multivariable linear regressions adjusting for age, sex, site, and childcare facility type and maternal sociodemographic characteristics to establish the role of child stimulation in child development. We will also examine the associations between caregiver-child interactions and neuroimaging profiles using simple and multiple linear regression methods adjusting for the same confounding variables. Both models will account for clustering due to the study site.

All the qualitative interviews will be recorded and transcribed verbatim. Qualitative data will be thematically analyzed to understand the perceptions and acceptability of MRI techniques in the study communities.

The Principal Investigator, project manager and data statistician will manage the data. This core research team is responsible for ensuring the integrity, confidentiality and quality of the data throughout the project life cycle. They will also grant permission for access to the data by other researchers or collaborators. This will occur particularly during key validation phases or during stakeholder engagements at community, county and national levels when data-driven insights need to be shared or interpreted collaboratively.

Data from this study will be under an embargo for two years after closing out of this study to allow for use by the research team. Thereafter, once all planned knowledge products have been completed, it will become publicly available to other researchers. All the study data will be permanently destroyed after five years.

Discussion

Despite the growing recognition of the clinical value of neuroimaging procedures, imaging studies exploring cognition among young children in LMICs remain scarce. While neuropsychological measures have provided valuable insights, direct investigations using neuroimaging techniques – particularly low-field MRI – are crucial to understanding the relationship between child stimulation and brain function. However, challenges such as high costs, limited accessibility, and negative community perceptions about MRI procedures hinder widespread use in LMICs. By integrating low-field MRI scans with behavioral assessments, this study seeks to offer a comprehensive understanding of early brain development and learning trajectories. The findings will contribute to evidence-based strategies for improving childcare practices and fostering optimal developmental outcomes in young children.

Community perceptions of neuroimaging are crucial in determining the feasibility and acceptance of such studies, especially in LMICs like Kenya. Misconceptions about MRI procedures often stem from informal sources like family and friends rather than healthcare providers, which can lead to hesitancy and resistance. To improve awareness and acceptance of neuroimaging techniques, it is essential to engage local leaders and employ culturally sensitive approaches. The sensitization sessions led by opinion leaders, policymakers, and researchers will be critical in demystifying MRI procedures. The use of mock MRI scans and culturally relevant dialogues will help improve acceptability among caregivers. However, challenges such as fear of radiation exposure and concerns about child safety may linger, requiring continued education and trust-building. We will target men in our efforts to build trust given the cultural and social dynamics in many settings where they are considered the main decision makers at the household level. We are aware that men play a pivotal role in shaping perceptions and supporting research efforts and it will therefore be critical to involve them to foster community acceptance.

Portable MRI technology offers promising potential to track structural brain changes in early childhood and inform targeted interventions, contributing to a deeper understanding of brain development in diverse contexts. In informal settlements, children often experience limited stimulation, which may have long-term effects on cognitive function and educational outcomes. By integrating neuroimaging techniques with behavioral assessments, the study will provide unique insights into the relationship between early experiences and brain structure.

Childcare is a core priority of the two counties where the project will be located as they are in the process of firming up their childcare regulations. The findings from this study could therefore inform policy changes aimed at improving early childhood care. Investments in training caregivers to engage more in verbal and responsive interactions could enhance brain development and learning outcomes in children.

Several risks were identified that could affect the feasibility of the study. The study team may experience low participant response rates as caregivers in informal settlements often relocate, making long-term follow-up difficult. Participants may have negative perceptions of MRI scans due to misconceptions about neuroimaging, and this may lead to community resistance. Younger children may struggle with remaining still during scans, which could affect data quality. Strategies such as intensive community sensitization, continual engagement with policy stakeholders, and non-invasive imaging techniques have been considered to mitigate these challenges.

Abbreviations

ANOVA

Analysis of variance

APHRC

African Population and Health Research Center

CDI

Communicative Development Inventory

CIP

Caregiver Interaction Profile

ECD

Early childhood development

ES

Effect size

ESRC

Ethics and Scientific Review Committee

FGD

Focus group discussion

GSED

Global Scales for Early Development

HICs

High-income countries

ISERC

Institutional Scientific Ethics Review Committee

ITERS

Infant-Toddler Environment Rating Scale

JOOTRH

Jaramogi Oginga Odinga Teaching and Referral Hospital

KII

Key informant interview

LENA

Language Environment Analysis

LMICs

Low- and middle-income countries

MELQO

Measurement of Early Learning and Quality Outcomes

MRI

Magnetic resonance imaging

NACOSTI

National Commission for Science, Technology and Innovation

SES

Socio-economic status

SRC

Scientific Review Committee

SSA

Sub-Saharan Africa

Author contributions

PK-W and MN made substantial contributions to the conceptualization of the study, shaping its research objectives and conceptual framework; NL contributed to structuring the study design, ensuring methodological rigor and alignment with the research goals; PK-W, MN, LO, SO, NL and PO collaborated in drafting the different sections of the manuscript, refining its presentation and coherence. All authors have reviewed and approved the final manuscript and have agreed to be personally accountable for their contributions. They commit to addressing any concerns related to the accuracy or integrity of any part of the work.

Funding

Funding for this work was provided by the Gates Foundation under agreement number INV-062467.

Data availability

No datasets were generated or analysed during the current study.

Declarations

Ethics approval and consent to participate

To ensure scientific integrity, participant safety, and adherence to ethical principles, the study underwent a rigorous multi-level ethical review and approval process. The protocol was first submitted to the African Population and Health Research Center’s (APHRC) internal Scientific Review Committee (SRC) which assessed its scientific soundness and ensured that the study promotes the safety and well-being of human participants and adheres to ethical principles. Following internal review, the protocol was submitted to and approved by Amref Health Africa’s Ethics and Scientific Review Committee (ESRC: Approval number P1665/2024). Additionally, it was reviewed for further ethical scrutiny and approved by the Jaramogi Oginga Odinga Teaching and Referral Hospital’s Institutional Scientific Ethics Review Committee (JOOTRH ISERC: Approval number ISERC/JOOTRH/077/24). After securing ethics approvals, the study team obtained a research permit from the National Commission for Science, Technology and Innovation (NACOSTI) ensuring compliance with national research regulations. Final approvals were granted by Nairobi and Kisumu Counties, allowing the study to proceed within these counties.

To ensure transparency and ethical integrity, we will provide a comprehensive explanation to study participants of the research purpose, procedures, potential risks, benefits and data usage before obtaining consent. Firstly, the consent procedures will include a section explaining that children will undergo scanning at a convenient time, preferably while asleep to minimize movement and enhance scan quality. We will explain that the procedure will last approximately 20–30 min, and that only the child’s head will be scanned to ensure minimal discomfort. Secondly, we will include a section informing the caregivers about the potential risks associated with the scanning process such as possible anxiety due to the confined space of the MRI scanner. We will also mention that the scans will be conducted by radiographers while explaining every step to the caregiver before the procedure begins. Strategies such as play-based acclimatization techniques will be used to help children feel comfortable. Thirdly, we will detail the indirect benefits of the MRI scan for their children including sharing our results with caregivers and stakeholders to inform better policies and practices that promote positive caregiver-child interactions. We will highlight that if an abnormal finding is detected, the child will be referred to appropriate care for further evaluation and support. Written informed consent will be obtained from eligible participants, ensuring they fully understand the study and voluntarily agree to participate. Complex medical terms will be translated into simple, accessible language to enhance understanding.

The study participants and the research team will sign the respective sections of the informed consent form. For individuals who cannot read or write, the consent form will be read and explained to them, and their thumbprint will be obtained in lieu of a written signature, witnessed by a designated witness. In cases where potential participants have disabilities that limit their ability to read or write, a witness will provide a written signature to confirm consent. A distinct consent process will be conducted for the neuroimaging component, ensuring that only those who explicitly agree will have their children undergo MRI scans. The study will utilize a low-field MRI machine which has been demonstrated to be safe for young children (Arnold et al., 2023). Brain measurements will be taken while the child is asleep to minimize movement and interruptions during the scan. Children will be accompanied by caregivers to reduce stranger anxiety and enhance comfort. We will encourage the caregivers to use soothing techniques as needed to help their children remain calm. Prior to MRI scanning, we will conduct sensitization and awareness meetings to ensure participants fully understand the procedure. Radiographers will provide step-by-step explanations to caregivers before the scan begins. If a child wakes up during the scan, the radiographers will request caregivers to soothe them back to sleep to ensure successful imaging.

The MRI scanning room will be restricted to study participants and authorized personnel, ensuring confidentiality and minimizing external interference. The radiographer will strive to complete each scan within the allocated 30-minute timeframe. After each scan, the radiographer will verify the quality of the images for accuracy before securely uploading them to the designated server. Strict data protection protocols will be followed to safeguard participant information.

All face-to-face interviews with study participants will be conducted in quiet, distraction-free locations, ensuring confidentiality and participant comfort. Efforts will be made to create a welcoming and secure environment, allowing participants to engage openly without external disruptions.

To ensure confidentiality, security and compliance with APHRC’s Data Protection and Privacy Policy we will implement a robust data management framework that safeguards participant information throughout the study. All collected data will remain private and will not be shared with anyone outside the research team. The data will be processed and shared exclusively through the shared analysis platform, ensuring controlled access. De-identification will be conducted at the initial data collection and entry stages, using unique codes for both MRI and behavioral datasets. Participant information will be assigned a randomized number instead of demographic details, ensuring anonymity. Only authorized researchers will have access to the coded data, which will be securely stored. This will ensure data integrity and prevent unauthorized use. All research data entered into computers and analysis software (FlyWheel) will be password-protected.

Participants will be informed that their data will be stored for five years post-study, in line with APHRC’s Data Protection and Privacy Policy. After five years, all study data will be permanently destroyed to uphold privacy standards. De-identified data will be shared with researchers upon reasonable request, ensuring ethical use while maintaining participant confidentiality.

Prior to any data collection activities in the two study counties, all research field interviewers and research team members will be required to sign a Data Confidentiality Agreement form. This measure will promote confidentiality, ethical compliance and data protection throughout the study.

Participants will be informed that participation is entirely voluntary, and they are not obligated to take part in the study if they do not wish to do so. If they choose not to participate, they will be assured that they can continue with their normal activities and will still receive all the regular community services. If a participant wishes to withdraw participation after enrolling, they will be informed that they may do so at any time by informing a research team member. Upon withdrawal, their data will no longer be collected, and any previously collected data will be permanently destroyed to uphold privacy and ethical standards.

Participants will be informed that the study does not provide direct benefits to them. However, the knowledge generated will be shared with the public to enhance understanding of caregiver-child interactions and brain development. The findings will contribute to improved policies and practices that support optimal early childhood development.

Participants will be informed that they will not receive direct financial compensation for their participation. However, we acknowledge that some individuals may need to travel long distances to attend scheduled interviews. To minimize financial burden, a standard transport reimbursement of Kenya Shillings 500 (equivalent to USD 4) will be provided to cover travel expenses for those who incur costs.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.