Implementation of a Mental Health Literacy e-Curriculum (MHLeC) in Malawi Universities: a feasibility cluster randomised trial protocol

Abstract

Background

Mental health literacy (MHL) in Malawi is low. Mental illness is often attributed to substance abuse or spirit possession, resulting in stigma, maltreatment, and discrimination towards people with mental health problems. Inadequacies in Malawi’s mental health services and workforce increase limited treatment access, knowledge, and negative attitudes, causing an epidemic of substance use and suicides. MHL is foundational for mental health promotion, prevention of mental illness, and stigma reduction. Educational settings are ideal for implementing mental health promotion activities. We want to deliver a MHL e-curriculum (MHLeC) to first-year university students in Malawi to improve their MHL. The project aims to assess the feasibility of implementing MHLeC in four Malawian universities within a cluster randomised trial.

Methods

In this pragmatic, cluster randomised feasibility trial, we will approach four to eight public and private tertiary institutions about study participation. Clusters will be participating universities allocated to the mandatory MHLeC or the voluntary MHLeC group using stratified randomisation on a 1:1 ratio. University type (e.g. public or private) will be used as the stratification factor for randomisation, with two levels ensuring two universities per stratum. This approach is appropriate for the four-cluster design. Specific feasibility objectives include (1) estimating likely participation rates of universities and students, (2) establishing potential attendance/retention rates during MHLeC delivery, (3) assessing acceptability of the MHLeC through qualitative feedback after intervention delivery, (4) assessing appropriateness of chosen questionnaires for measuring student outcomes.

Data will be analysed descriptively. Outcomes from data collected will inform the feasibility of a future main trial including main trial design and recruitment strategies, sample size and power calculations for a full-scale cluster randomised trial.

Discussion

This trial will give us insights on how best to conduct the definitive trial. The intervention can be rolled out nationally within a full-scale trial in Malawi and tested in similar cohorts across Africa if positive results are obtained. More broadly, this research has the potential to significantly increase mental health awareness among young people in Malawi.

Trial registration

This study is registered on the Pan African Clinical Trials Registry (PACTR) website https://pactr.samrc.ac.za/ (PACTR202308849574524). Registered 31st August 2023.

Background

Depression is a serious healthcare problem that, if left untreated, contributes to premature mortality, increased morbidity, poor quality of life, and poor career progression for young people [1]. In Malawi, depression is common, with prevalence rates of up to 21% in adolescents [2, 3]. Several factors in Malawi contribute to low mental health literacy (MHL). Primarily, there is a lack of knowledge on how to tackle mental health problems in Africa, especially for young people, and Malawi is not exempt from this [4]. Many people in Malawi attribute the causes of mental health disorders to alcohol and drug abuse or spirit possession, resulting in stigma, maltreatment, and discrimination towards people with mental health issues [4, 5]. Additionally, the country’s lack of mental health services, facilities, and healthcare professionals amplifies limited treatment access, knowledge, and negative attitudes [6]. In 2011, only four psychiatrists were serving the entire country’s population of 15.7 million, and no child and adolescent psychiatrists [6, 7].

Malawi also has multifaceted development challenges that affect MHL. Eighty percent of development expenditure for Malawi’s health sector is donor-supported resulting in neglect of basic primary healthcare systems and preventive health services particularly in rural Malawi [8]. Further, the majority of youth in Malawi (82%) live in rural areas and are exposed to challenges such as poor-quality jobs, early marriages, and difficulties accessing healthcare [9]. These social inequalities such as youth unemployment are well-known risk factors and consequences for mental health problems, substance use, and suicide [4, 10, 11]. Malawi, like any other African country, needs to prioritise addressing depression and other mental illnesses among young people as a healthcare need [1].

In addition, the impact of COVID-19 on mental health in sub-Saharan Africa has been immense, given that uptake of treatment services is generally low, and communities rely on social resources [12]. Learning in Malawi and the rest of the world came to a standstill due to COVID-19 restrictions as such students became concerned about their future professional careers and studies and experienced boredom, anxiety, and frustration while waiting for normalcy [13, 14]. Although the COVID-19 pandemic brought with it massive global human suffering, it has presented an opportunity to assess successful technologies for education, the costs associated with them, and their potential to improve access to education for young people in sub-Saharan Africa [13].

MHL is foundational for mental health promotion, prevention of mental illness, stigma reduction, and care [7] if mental health problems are to be dealt with. Most young people spend most of their time in educational settings, making schools and universities ideal settings to implement mental health promotion activities. A study conducted by Kutcher and colleagues [1] in Malawi and Tanzania found that the application of a horizontally integrated pathway innovation that merges MHL development at the school and community level as well as linking schools to community support clinics showed positive impacts and was ready for mental health policy application. The study, however, emphasised the need for further study on the implementation process.

Mental health promotion which can target MHL, normalise mental health issues, and challenge negative perceptions of mental illness as a solely severe condition is uncommon. This leaves a substantial need and opportunity to address youth mental health literacy in Malawi and set the ground for interventions in this area. In a scoping review aimed at identifying and describing interventions that promote mental well-being among adolescents in Sub-Saharan Africa, only three countries: Uganda, Kenya, and South Africa made up more than 50% of the identified interventions, showing low prioritisation and few mental health promotion interventions in most other African countries [15]. Therefore, there is a need to invest in youth mental health promotion interventions and research in Malawi.

The feasibility trial in this protocol is the next step in building on Kutcher’s research and our previous study, which focused on engaging youth in Malawi to inform adaptation of a mental health literacy intervention [1, 4, 16] to develop and deliver an MHL e-curriculum to university students. Based on feedback on our prior research and pilot study from our youth-led advisory group of project partners and stakeholders called the intervention development group (IDG), the content of the e-curriculum will focus on increasing mental health awareness, demystifying mental illnesses, reducing mental illness stigma, promoting health-seeking behaviour, linkages to support services, and prevention of mental health issues by using a pragmatic blended course delivery approach. This study’s primary objective is, therefore, to assess the feasibility of implementing the MHLeC to first-year students in Malawi universities within a randomised feasibility trial. The secondary objectives of the study are to (1) assess the best recruitment strategies and retention; (2) assess the appropriateness of chosen pre and post-intervention outcome measures; (3) assess the feasibility of the online delivery format by collating information on numbers/percentages of students accessing and completing the MHLeC assessments online; (4) conduct a process evaluation to help us understand how the MHLeC impacted on specific outcomes (or not), including identifying key facilitators and barriers to implementation success; (5) evaluate the use of community engagement approaches to promote mental health discourse and disseminate research findings beyond youth in university settings. This work will be conducted as part of a PhD student project.

Methods

This is a mixed methods feasibility study [17] involving the delivery of an educational mental health literacy curriculum (MHLeC) to 1 st year university students, evaluation of attendees’ MHL (knowledge and attitudes), mental wellbeing, and substance use levels before and after receiving the curriculum. A pragmatic, cluster randomised controlled trial will be conducted with universities as the unit of randomisation (cluster). Universities will be allocated to the Mandatory MHLeC or Voluntary MHLeC group using stratified randomisation with a 1:1 ratio (see Fig. 1). We will also conduct a process evaluation to explore facilitators and barriers to the implementation of MHLeC which will include qualitative focus group discussions with participating students and MHLeC facilitators. Public engagement activities in community settings and on social media will be conducted alongside the implementation of the MHLeC in universities to increase the reach of mental health awareness among young people outside university settings.

Fig. 1.

MHLeC Feasibility Trial CONSORT Diagram (CONSORT - Consolidated Standards of Reporting Trials)

The eligibility criteria for the study participants are as follows: (1) a public or private university in Malawi with the curriculum taught in English (N.B: the main medium of delivery is English) and potential infrastructure for delivery of online teaching to students; (2) any first-year students, fully enrolled in a participating university (student identification (ID) numbers to be used for validation), able and willing to give written informed consent, committed to participate in 4 of 6 MHLeC sessions and engage with the online curriculum by themselves to complete assessments, and able to use smartphones, laptops, or computers with or without others’ support. The exclusion criteria include (1) those unwilling or unable to give consent independently; (2) inability to understand written and/or verbal English; and (3) people judged to be unsuitable for participation in this research by the research team due to severe mental or cognitive problems (memory problems, severe depression score on Patient Health Questionnaire-9 [PHQ9]).

Recruitment

The main motivation for conducting a cluster randomised study is to reduce contamination bias [18]. Our research project is being conducted in educational settings. If we used the individual randomisation approach in this setting where in each university we randomise individual students to receive either mandatory or voluntary MHLeC, bias (distortion or systematic error) could be caused by interactions between students in different study arms [18]. Another important reason for using cluster randomisation in our study is the fact that natural clusters exist in educational settings because learning is usually done in groups, for example, by degree programme. We will therefore take advantage of these naturally set groups when delivering our intervention, especially in the mandatory arm. Baseline data on university characteristics will be collected by the MHLeC study team prior to randomisation. Given that four universities will be randomised, we have simplified the stratification approach to a single factor (university type, e.g. public or private), which has two levels ensuring two universities per stratum. This allows one public and one private university to be allocated to each arm, maintaining meaningful balance while avoiding over-stratification. Four universities will be randomised in stratified block sizes of two clusters all at once. This randomisation will be conducted using an online software called Sealed Envelope [19]. The study team recruiting the universities will email an independent statistician with details of consented universities for allocation. The independent statistician will then perform the randomisation using the online software and then notify the study team of each university allocation by email.

For student recruitment, the MHLeC research team will go to participating universities to approach all first-year students about the study. This will involve an introductory talk with the whole cohort (facilitated by university leads). They will watch a study information video (co-designed by our youth-led project advisory group) that will inform them that their university is participating in the MHLeC project and requires first-year students to complete the MHLeC. Students will be told that completion of the MHLeC is mandatory or voluntary based on the arm of the trial that their university is randomised into. We have opted to not have a control arm because the MHLeC is adapted from an evidence-based MHL intervention that has been tested across the globe and shown to be effective [1, 11]. In this feasibility trial, our focus is to test implementing the intervention in different ways (online vs. face to face), directly to university students in Malawi using a mandatory versus a voluntary approach. Feasibility trials commonly involve new, unestablished interventions. In our case, it is beneficial to have as many participants as possible receiving the intervention to align with our feasibility aim, which is focused on gaining experience of delivering the intervention in different ways to find out which ways work best.

Students in the mandatory arm will be told that their attendance to MHLeC sessions is obligatory while interested students of the voluntary arm will be told to join a mental health club where they can participate in the MHLeC sessions. MHLeC registration for both arms will include reading through the participant information sheet (PIS) again, providing online or paper informed consent, and completing baseline questionnaires that will include basic demographic questions, two MHL questionnaires, PHQ9 and CRAFFT either by using the printed or online questionnaires based on their preference. Students will be encouraged to seek clarification from the research team where necessary and will be given the Principal Investigator’s (SJ) contacts to ask questions over the study duration.

In-person assessments for this feasibility study consist of completing self-reported questionnaires (see ‘study measures’ section for details). The research team will conduct in-person assessments with participants in their natural settings, i.e. classroom format. We envisage the MHLeC intervention being delivered as a taught classroom module. Similar to how the baseline questionnaires were completed in our pilot study, the research team will hand out paper copies of the questionnaires’ booklet to each participating student during the introductory MHLeC session and then collect them during the session once completed. Once the baseline questionnaires are completed and the study team has ensured that the students meet the eligibility criteria, they will be classed as fully registered onto MHLeC and subsequently receive a confirmation email a few days later containing a date for their first MHLeC classroom or online session and subsequent planned five classroom sessions. Those who successfully complete the MHLeC sessions will receive a certificate of completion. Participating students will be contacted again 3 months after their last MHLeC session to complete post-MHLeC questionnaires, which will be used to assess long-term retention of mental health knowledge and overall changes in MHL, mental wellbeing, and substance use.

Figure 2 shows the phases of the MHLeC feasibility trial schedule of enrolment, interventions, and assessments in accordance with SPIRIT guidelines.

Fig. 2.

SPIRIT figure for MHLeC feasibility trial

Sample size

The average annual intake numbers of students across Malawi’s public and private universities are estimated at between 40,000 and 50,000 [20]. The Ministry of Education 2022 report on ‘Malawi Education Statistics’ states enrolment figures of 56,624 students into Malawi universities of which 34,964 were from public universities and 21,660 were from private universities. As there are roughly 20 universities in Malawi, we will recruit four universities in this feasibility trial for pragmatic reasons which will leave at least 16 universities for the main future full-scale trial [21]. We plan to randomise clusters at the university level, ensuring we have a balance between private and public universities by using stratification, along with student cohort sizes to minimise significant variation in cluster sizes.

This sample size calculation is based on our previous study [16]. Teare and colleagues, for example, suggest that usually, a sample size of 70 is enough to determine a precise enough standard deviation that can then be used in a full trial sample size calculation [22], that is, 35 participants in each arm for a continuous outcome like a questionnaire. For our study, the proposed primary outcome for the main trial would be a mental health questionnaire. One of our aims is to calculate attrition across clusters; if we anticipate a 40% dropout rate based on our prior research, where only 20 out of the initial 35 participating students completed their post-assessment questionnaires. We therefore propose 20 students in each university class, which is a total of 80 students across the four classes per university (university cluster). Considering a 40% dropout rate, that is 80/0.6 [i.e. 80/60 multiplied by 100], this gives a total sample of 134 first-year students per university. Multiplied by four universities, that gives 536 1 st year students [23] which is about average for a cluster randomised feasibility study average cluster sizes 32 IQR [14 to 82]. [24]

We anticipate variation in student participant numbers within and between the university clusters due to differences in first-year student enrolment numbers between public and private universities in Malawi. Specifically, private universities have typically smaller numbers and therefore smaller classes per program. We will document these differences and use the information in a pragmatic sample size power calculation for the main trial.

MHLeC intervention

The MHLeC content is based on the Canadian school mental health curriculum resource which was already adapted for use in Malawi for teachers, adolescents, and youth [7]. We have further refined this resource for use with university students, aligning our goals with the World Health Organisation’s (WHO) action plans to support the Sustainable Development Goals 3, 4 and 10 by promoting good mental health whilst reducing inequalities around health literacy within Malawi. We conducted three intervention development group (IDG) workshops with our stakeholders to help shape the general content for our target population and get practical-level insights on things that need to be adapted for the Malawi audience, e.g. Malawian lived experiences, local sources of mental health support (see Table 1).

Table 1.

MHLeC course outline

Module	Topics	Resources/assignments	Session length
Module 1: Stigma of mental health	• Defining stigma • Stigma: myths and realities about mental illness • Digital stories on mental health in Malawi	Group task: how one can reduce mental illness stigma every day	60 min
Module 2: Mental health and mental illness	• Mental health and mental illness: the common bias • The interrelationship of health states: language matters	Resources: • Brain growth and development infographic • Malawi Quick Guide to Mental Health link	65 min
Module 3: Information on specific mental illness	• What happens when the brain gets sick? • Common mental illnesses • Exploring mental illness	Resources and tasks • Reflective questions for each topic • Type of mental disorder quiz in Vignettes video	75 min
Module 4: Experiences of mental illnesses	• Experiences of mental illness and the importance of family communication • Mental health experiences in Malawi videos • Importance of family communication	Resources: video discussion sheet and 2 family communication hand outs Group discussions: on mental health experience videos Group task: (1) on family communication about mental health. Groups to act out in class	80 min
Module 5: Getting help and finding support	• Treatment and recovery • Guided ‘Getting help’ group task • Signposting to local support organisations for youth in Malawi	Resources: • Recovery handout • Support strategies	65 min
Module 6: Prevention	• Stress management • Suicide prevention	Group discussions: 1) Why do students experience stress? (10 min) 2) Reflect on stress triggers and coping strategies (15 min)	60 min

The MHLeC content has been uploaded onto Millennium University’s digital platform (MyMU), which can accommodate both internal and external students through a secure login system. All registered students of the trial will access the online MHLeC content using a unique ID and password provided by MyMU.

The MHLeC will be delivered in a blended format (mix of classroom and online delivery) depending on participating universities’ needs. Due to the unpredictable nature of electricity supply in Malawi, in cases where there are electricity problems, the curriculum can still be delivered if using the classroom modality. Universities could subsequently opt to use both modalities or just one depending on their situation. The pragmatic blended approach will ideally have both the classroom in-person mode of delivery with online access to the MHLeC throughout the implementation or completely digital.

Study measures

Primary outcome

Intervention completion rate

We will calculate the completion rate of classroom session attendees by dividing ‘the number of study participants who attended four or more classroom sessions’ by ‘the total number of people registered to the study in each university cohort’. The proportion of students completing the online MHLeC will be calculated by dividing ‘the number of study participants who complete the final MHLeC online assessment’ by ‘the number of people registered to this study’.

Secondary outcomes

Recruitment rates

Recruitment rates of universities will be noted by calculating the percentage of universities recruited from the total approached about the trial. We will calculate the student recruitment rate by dividing ‘the number of first-year students recruited to the trial’ by ‘the total number of first-year students approached about the study’.

Retention rates

Retention will be calculated by counting the number of consenting student participants that withdraw and/or dropout of the trial soon after intervention delivery and at 3 months follow-up point in each cluster/arm.

University-level (cluster) feasibility outcomes

Assessing institutional-level feasibility is a primary component of this study, given that universities are the unit of randomisation and act as gatekeepers for student participation. The following cluster-level feasibility metrics will be recorded and reported:

1. University recruitment rate: the proportion of approached universities that provide consent to participate in the trial, calculated as the number of consenting universities divided by the total number of universities approached.

2. University delivery completion rate: the proportion of randomised universities that successfully deliver the full MHLeC programme (all six modules) to their allocated student cohort, calculated as the number of universities completing full delivery divided by the total number of randomised universities.

3. Institutional data completeness rate: the proportion of participating universities that provide complete institutional data required for the trial (e.g. baseline university characteristics, student register data, and attendance records). These cluster-level outcomes will be reported separately from student-level outcomes in the data analysis (see Analysis of Quantitative Data section) and assessed against the pre-defined progression thresholds in Table 2.

Table 2.

Stop–go criteria for going forward with the main trial

Criteria	Stop (red)	Need changes in approach (amber)	Go (green)
University recruitment rate (cluster-level)	< 50% (i.e. 0–1 universities)	50–70% (i.e. 2 universities)	> 75% (i.e. 3–4 universities)
University delivery completion rate (cluster-level)	< 50% (i.e. 0–1 universities) of randomised universities complete full MHLeC delivery	50–75% (i.e. 2–3 universities) of randomised universities complete full MHLeC delivery	> 75% (i.e. 3–4 universities) of randomised universities complete full MHLeC delivery
Completion of primary outcome by students (individual-level)	< 40%	40–60%	> 60%
Adherence/attendance to MHLeC modules (individual-level)	< 2 session average	2–4 session average	4–6 session average

Questionnaires completion rate

Questionnaires’ completion proportion will be calculated by dividing ‘the number of people who have completed their questionnaires at baseline, immediately after the MHLeC intervention and 12 weeks later’ by ‘the total number of consenting student participants who have not withdrawn from this study at the relevant time point’. That is, the denominator at each assessment time point consists of only participants who remain actively enrolled in the study at that time and have not previously withdrawn or dropped out. The questionnaires to be completed are detailed below:

The Mental Health Literacy Questionnaire (MHLq) for Young Adults, which assesses general mental health knowledge in general populations, has shown strong evidence for content validity, internal consistency, and moderate reliability [16, 25, 26]. It measures MHL on four dimensions: (1) knowledge of mental health problems, (2) erroneous beliefs/stereotypes, (3) help-seeking and first aid skills, and (4) self-help strategies. Participants are asked to rate each item, ticking the option that indicates how much they agree or disagree using a five-point scale (ranging from 1 = strongly disagree to 5 = strongly agree) to respond to the items. We have translated this questionnaire into Chichewa and tested psychometric properties in urban and rural community settings in Malawi [16].

The School Mental Health Questionnaire (SMHQ) contains a series of surveys that measure mental health knowledge, attitudes toward mental health and mental illness (stigma against mental illness), and outlook toward help-seeking [26–28]. For the first 30 questions measuring mental health knowledge, respondents choose from one of three options: ‘true,’ ‘false,’ or ‘do not know.’ Each correct answer receives one point for a total possible score of 30. Participants are encouraged to choose ‘do not know’ to reduce the likelihood of guessing. Eight questions assess an individual’s attitudes toward mental health and mental illness (stigma of mental illness), using a 7-point Likert scale ranging from ‘strongly disagree’ to ‘strongly agree.’ Five questions that address participants’ attitudes about seeking help when concerns arise regarding their mental health or a friend/family member’s mental health are also answered based on a 7-point Likert scale ranging from ‘strongly disagree’ to ‘strongly agree.’ Overall higher scores reflect higher mental health knowledge, positive attitudes, and outlook toward help-seeking.

The Patient Health Questionnaire-9 (PHQ-9) is a nine-item questionnaire for measuring the severity of depressive disorder symptoms, and the verification of the reliability and validity of the Chichewa version has already been reported [29]. For the symptoms of the past 2 weeks, the items on PHQ-9 are rated on a 4-point Likert scale where 0 = never, 1 = several days, 2 = more than half the days, and 3 = almost every day. Obtaining 0–4 points implies that one does not exhibit symptoms of depression, 5–9 indicates mild symptoms of depression, 10–14 signifies moderate symptoms of depression, 15–19 points indicate that one exhibits moderate to severe symptoms/level of depression, and 20–27 points indicate severe symptom levels.

The Car, Relax, Alone, Forget, Friends, Trouble (CRAFFT) tool is a well-validated substance use screening tool for adolescents and young adults aged 12–21, typically used for preventive care screenings [30]. This questionnaire is a brief and effective screening tool with a series of 6 questions developed to screen for high-risk alcohol and other drug use disorders simultaneously. The CRAFFT has two parts: part A, composed of three questions referring to alcohol, marijuana, and other drugs consumed in the last 12 months; and part B with six questions about problems related to the consumption of such substances. The response format is dichotomous (yes/no). If the answers to the three questions from part A are “No”, only the first question from part B of the questionnaire is asked. In contrast, if “Yes” is answered to any of the three items of part A, part B of the scale is carried out, which is the only part where the score is given. In the case of a negative response (no), a score of zero is assigned, while an affirmative answer (yes) is assigned a score of one point. To evaluate the questionnaire, the scores of the six items of part B are added up. Scores equal to or greater than 2 suggest the presence of abusive consumption.

Fidelity of MHLeC delivery

To explore how well facilitators stuck to the course structure and content during delivery, we will audio record at least two sessions delivered per cluster. These recordings will be listened to by researchers who are not part of the MHLeC delivery team (e.g. Masters students) and cross-matched against the MHLeC course outline using a fidelity mapping checklist.

Process evaluation

Qualitative FGDs, either face-to-face or virtual depending on participants’ preferences, with students who participated in the trial and MHLeC facilitators will be conducted by the research team to assess the acceptability of the MHLeC content. The P.I. will manage the qualitative evaluation process along with research assistants from Millennium University (postgraduate research students). The script of questions to be asked by the research team will be developed with the IDG, as they will have been briefed on findings and challenges as the trial progresses. The research team will contact potential individuals who indicated their interest to be interviewed on their consent form to reconfirm their informed consent prior to commencing their participation. The qualitative study sample size estimates will be subsequently informed by ‘saturation point’, that is, a point where no new information is discovered in the data analysis process, providing reasonable assurance to the researchers that further data collection would yield similar results and serve to confirm emerging themes and conclusions [31, 32].

MHLeC facilitators will include university staff involved in the delivery and/or planning of logistical aspects of implementing the MHLeC into their existing curriculum, and the FGD will focus on their views on the mode of delivery and student engagement.

We have developed stop-go progression criteria to inform decision making about proceeding from this feasibility study to a larger more definitive trial (Table 2). These pre-defined quantitative thresholds serve as formal decision points rather than merely descriptive benchmarks: a red (stop) result on any criterion indicates that the trial is not feasible in its current form and cannot proceed to a full-scale trial without substantial redesign; an Amber result indicates that modifications are needed before proceeding; and a Green result indicates feasibility for a full-scale trial. Thresholds are defined at both the cluster (university) level and the individual (student) level, reflecting the dual structure of this cluster randomised trial. The criteria are based on discussions within the study team and are guided by progression criteria guidance in the literature [40], our study aims, the study team’s expertise in leading qualitative studies on barriers and facilitators to mental health services, [4, 33] in addition to feasibility and full-scale trials in mental health [34–36]. Student-level completion and attendance thresholds are informed by our previous pilot work, where 20 out of 35 students (57%) completed post-assessment questionnaires. Qualitative and quantitative data will be collected during this pilot to evaluate the progression criteria outlined in Table 2 which includes the feasibility of participant recruitment, retention rates, acceptability of the MHLeC and appropriateness of chosen questionnaires for measuring student outcomes.

The red (stop) category for each criterion indicates that a future full-scale trial is not feasible under current conditions without substantial redesign. The amber category indicates that modifications to recruitment strategies, intervention delivery, or study procedures are required before proceeding. The green category indicates that a future full-scale trial is feasible with minor refinements.

Public engagement activities

We will run community public engagement festivals yearly to connect with young people and their peers, to promote mental health discourse beyond universities. Alongside festival activities will be panel discussions and debates targeting MHL on social media and media channels (radio, TV). These events will be advertised on radio stations and social media.

Our local partners, including National Youth Council of Malawi (NYCOM), Drug Fight Malawi, . already have experience of working with young people, their peer groups, and families. They will facilitate the organisation of our outreach activities and be our link to the local community.

Data analysis

Analysis of quantitative data

We will use the Statistical Package for Social Sciences version 29 (SPSS-29) to analyse quantitative study data. Feasibility outcomes will be reported descriptively and narratively by allocation arm (mandatory MHLeC vs. voluntary MHLeC). Outcomes will be reported separately at the cluster (university) level and the individual (student) level to distinguish institutional-level feasibility from participant-level engagement. Descriptive statistics, such as means (standard deviation), counts and percentages will be used to characterise the sample using data from completed baseline demographic questionnaires. Feasibility outcomes regarding MHLeC implementation measures like recruitment and retention rates, i.e. number of universities recruited, number of first-year students recruited to the trial, number of MHLeC sessions delivered, withdrawal and dropout rates, will be reported using raw counts (%). Students’ attendance rates (at least 4 classroom sessions) and level of student engagement with the online MHLeC platform will be reported using raw counts (%) and narratives. University-level (cluster) feasibility outcomes including university recruitment rate, delivery completion rate, and institutional data completeness will be reported as counts and proportions and assessed against the pre-defined cluster-level stop–go thresholds in Table 2.

To compare questionnaire completion rates over time (baseline vs 3 months post-MHLeC delivery) to determine the appropriateness of their use as data collection tools for a main trial, means (standard deviation) for continuous data like MHL scores, with 95% confidence intervals will be reported. Medians (range) for ordinal data, and raw counts (%) for nominal data, will be reported. Due to the nature of this feasibility study, we will not conduct any efficacy statistical tests on MHL data as the trial is not powered for testing hypotheses about effectiveness.

We will look at differences between the two arms to carry out power calculations for the main trial. We will also calculate the intraclass correlation coefficient (ICC) across the participating universities to do the cluster randomised power calculation.

Analysis of qualitative data

Framework thematic analysis of focus group transcripts will be led by SJ, who is well experienced in this qualitative methodology, to identify patterns of meaning and themes across the data. A bottom-up inductive approach will be used when interpreting participant accounts. In accordance with Braun and Clarke’s thematic approach [31] we will follow the essential six stages for a thematic analysis. In line with outlined qualitative research recommendations, the proposed sample size is considered appropriate for a medium to large-scale thematic analysis study [37]. To increase rigour in the qualitative analysis process, ongoing feedback on themes will be sought from the research team to verify the analysis and general interpretation of data. The researchers will keep a reflective journal throughout the recruitment and data analysis process to increase the transparency of preconceptions in the research and to aid critical self-reflection of the research process [38].

Data collection and storage

Completed electronic questionnaires from study participants will go directly to a secure electronic database. This allows direct collection of data from the source, minimises human error when manually entering data, and ensures secure storage. The MyMU system allows for data collection using Android mobile devices. We will implement a system where data submission to an online server is possible even without an internet connection or mobile carrier service at the time of data collection. This would be ideal for our project when researchers are working in rural areas or offline. Paper-based questionnaires will be made available should the students choose to use them instead.

Data will be stored, managed, and archived by the data management team at Millennium University (MU). On completion of the study, a full data extract will be securely stored on a data drive at MU to enable data cleaning, analysis, and data sharing. Electronically signed participant consent forms will be held separately from new data generated on a secure server and paper records kept in a locked cabinet at Millennium University.

The study team will set up study-specific standard operating procedures for this project in line with existing standards to safeguard the secure storage of participants’ personal data. All researchers will have Good Clinical Practice (GCP) in Research training and Information Governance training.

Ethics and dissemination

We sought ethical review and approval from the National Research Committee on Social Sciences and Humanities (NRCSH) in Malawi. The Data Management and Statistical Analysis plans have been written in line with Millennium University’s (host institution) support services policies and relevant standard operating procedures on data management and information governance to ensure data generated within this project are of high quality and processing is well documented.

We will further seek informed consent from willing universities prior to approaching their students about the curriculum. In this cluster randomised trial, university administrators act as gatekeepers—individuals or bodies who are called upon to protect the interests of organisations or communities that are the setting for a cluster randomised trial [39]. Critically, assessing gatekeeper engagement and institutional feasibility is a primary and distinct component of this feasibility evaluation, not merely a precondition for student recruitment. Whether university administrations are willing and able to integrate the MHLeC into their existing curriculum structures is itself a key feasibility question, formally evaluated through the cluster-level feasibility outcomes and stop-go criteria described in the Study Measures section and Table 2.

Upon receiving consent and permission from the universities, we will approach students and explain the purpose of the research to them using both written participant information sheets and a video presentation (with subtitles) in both English and Chichewa to aid understanding and widen the participation of those with special needs, i.e. students with hearing or visual impairments. We will then take individual consent from student participants to use their data collected and follow them up as part of this research study. Participants will be told that they are free to withdraw any of their data collected at any time. We will then start implementing the MHLeC in line with the different recruited Malawian universities’ curriculums for first-year students. We will offer appropriate support to our participants throughout the study’s duration by signposting them to in-house university protocols for mental health support (if available) and other locally vetted mental health services.

For our academic audience, study results will be published in open-access peer-reviewed journals and presented at international meetings like Africa Health Agenda. We will also conduct research dissemination workshops virtually or in person with grassroots community organisations in Malawi to inform future mental health literacy interventions and research in the country.

For our non-academic audience, we have an official project website (https://mhlec.com/) for participants and the public to follow the study’s progress through newsletters and other digital content. We will provide the project website link to university students, partners, and stakeholders during meetings. Additionally, we will be socially media active via the project’s social media pages on Twitter, Facebook, LinkedIn, and Instagram where we will tag key stakeholders. A project YouTube channel has also been created to share video interviews, research dissemination workshops, and other relevant project outputs linked to youth mental health in Malawi.

To reach the rural masses, we will have community outreach programmes and annual festivals where information about the project and findings will be communicated in non-technical terms. We will have scheduled programmes and advertise the project through interviews on radio and TV stations if affordable.

Public involvement

This project has been developed following needs highlighted at the grassroots level. Since 2018, the Principal Investigator (PI) has been speaking to Malawian individuals and community groups with either lived experience of mental health problems or relatives/friends who have substance use problems and gained insights on the local contextual issues in this area.

The PI and co-researchers will continue to engage key community groups (youth leaders, local health and social organisations, schools, and youth groups) to discuss their knowledge and experiences of mental health in Malawi with the view to inform potential research agendas that align with local needs.

We have already begun the process of stakeholder mapping and have managed to identify and collaborate with key practitioners (researchers, teachers, and clinicians), policymakers and government agencies (Malawi’s Ministry of Education and National Council for Higher Education) and associated development actors, National Youth Council of Malawi and Drug Fight Malawi in Malawi among others, who have helped to develop this proposed work and previous work on mental health.

In one of our previously published research articles on mental health literacy in Malawi titled ‘We do not talk about it’ [4] we used online focus group discussions (FGDs) to obtain views from young people in Malawi on mental health issues. This method has since proven to be effective in not only acquiring views from youth on mental health but also in growing our stakeholder network, strengthening the potential for future community engagement activities and broader research dissemination. Following the initial pilot of MHLeC amongst first-year students at Millennium University, we conducted a series of workshops with our project stakeholders to further refine the MHLeC content to enhance the intervention’s cultural relevance. We also used these workshops to review our study design and recruitment strategies for the overall feasibility trial study design. We will therefore continue to use online FGDs, interviews, and workshops which will guarantee greater reach and public involvement with limited resources, just as we have already done with our IDG co-design workshops.

Discussion

Mental health literacy is assumed to be low in developing countries like Malawi. Understanding of mental illness is clouded by myths and misconceptions that result in stigma, maltreatment, and discrimination of people with mental health problems and their families. Malawi’s under-resourced mental health services and overburdened workforce exacerbate issues like limited access to treatment, limited knowledge, and negative attitudes regarding mental health issues. This paper provides a detailed overview of how we plan to implement a mental health literacy e-curriculum in universities and higher education colleges as part of a feasibility trial, alongside public engagement with stakeholders and youth in communities to further promote mental health literacy. This feasibility cluster randomised trial has been designed to provide evidence of whether a definitive trial of effectiveness could be undertaken. Alongside the study’s stop–go criteria in Table 2, a process for decision-making after pilot and feasibility trials, commonly known as ADePT will be used to classify and analyse problems arising from the feasibility study as an aid to identifying appropriate solutions, specifically, to clearly state whether the aims and objectives of our feasibility work have been met and are going to lead on to a future large-scale study [40].

Conclusion

This work is needed as it will make a significant difference to generating evidence regarding how to increase awareness of mental health literacy among young people in Malawi. According to our knowledge, this feasibility trial will be the first of its kind in Malawi universities and targeting the youth. If results are positive, our intervention can be rolled out nationally in Malawi and tested in similar cohorts in other parts of Africa.

Abbreviations

COVID-19

Coronavirus Disease 2019

CRAAFT

The Car, Relax, Alone, Forget, Friends, Trouble tool

FGDs

Focus Group Discussions

GCP

Good Clinical Practice

ICC

Interclass Correlation Coefficient

ID

Identification

IDG

Intervention Development Group

MHL

Mental Health Literacy

MHLeC

Mental Health Literacy e-Curriculum

MHLq

Mental Health Literacy Questionnaire

MU

Millennium University

MyMU

Millennium University’s Digital Platform

NCRSH

National Committee on Research in Social Sciences and Humanities

NYCOM

National Youth Council of Malawi

P.I

Principal investigator

PhD

Doctor of Philosophy

PHQ-9

Patient Health Questionnaire–9

PIS

Participant Information Sheet

SMHQ

School Mental Health Questionnaire

SPSS-29

Statistical Package for Social Science Version 29

WHO

World Health Organisation

Authors’ contributions

Contributors SJ, RH, CN, and GC contributed to the study conception and the design of the protocol development. SJ contributed to the intervention design. BC and JN developed the study materials for study participants’ recruitment. SJ is the project lead. SJ and GC developed the data analysis plan. GC wrote the first draft of the manuscript. SJ, RH, MU, and CN reviewed the manuscript and recommended critical revisions. All authors have approved the final version of the manuscript.

Funding

This document has been produced with the financial assistance of the European Union (Grant no DCI-PANAF/2020/420-028), through the African Research Initiative for Scientific Excellence (ARISE) pilot programme. ARISE is implemented by the African Academy of Sciences with support from the European Commission and the African Union Commission. The contents of this document are the sole responsibility of the author(s) and can under no circumstances be regarded as reflecting the position of the European Union, the African Academy of Sciences, and the African Union Commission.

Data availability

The datasets used and/or analysed during the current study, statistical code and the full protocol are available from the corresponding author on reasonable request.

Declarations

Ethics approval and consent to participate

The ethical aspects of the research protocol with reference number NCST/RTT/2/6 and protocol number P.07/23/782 have undergone review by the National Committee on Research in the Social Sciences and Humanities (NCRSH) in Malawi.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.