Study protocol for a Critical Realist pilot cluster-randomised controlled trial of a whole-school-based mindfulness intervention (SBMI) promoting child and adolescent mental wellbeing in Rwanda and Ethiopia

Background This research uses a critical realist approach to understand how and why school-based mindfulness interventions designed to promote child and adolescent mental wellbeing work or do not. Poor mental wellbeing is the leading cause of illness among children and adolescents in sub-Saharan Africa, with an estimated prevalence of 1 in 7. There is evidence that school-based mindfulness interventions promote child and adolescent wellbeing. Still, few interventions have been trialled in SSA, and none have examined how and why mindfulness interventions work. Methods Using a Critical Realist pilot cluster-randomised controlled trial; we will evaluate a school-based mindfulness intervention compared to the regular curriculum over one school year. Incorporating mindfulness into the primary school curriculum will provide proactive reach to all CA. The intervention will be codesigned by teacher educators, schoolteachers, policy actors and community members, including CAs. In each country, three schools will be selected and randomised as pilot, intervention, or control/waitlist. The mindfulness intervention will be integrated into the school curriculum and taught to all children attending the schools by classroom teachers trained to deliver it. Quantitative research will be used to measure the outcome of the intervention, and qualitative research to answer how and why questions. The primary outcome is improved mental wellbeing of pupils measured by the Acholi Psychological Assessment Instrument. Secondary outcomes will include subjective quality of life, school 'climate', school performance, and satisfaction with school. Pupils, teachers and main carers in intervention and control/waitlist schools will fill in questionnaires before and after the intervention and process evaluation will be carried out in intervention schools. The cost-effectiveness of the mindfulness intervention will be assessed. Discussion The evaluation will provide new interdisciplinary knowledge, and methods, to understand and sustainable impacts on CA mental wellbeing in these settings. Independent research and intervention teams will run the trial. Registration of Project : Research Registry 8799, Mar 31 2023 ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial Research Registry 8799 ### Funding Statement The research is funded by the National Institute for Health and Care Research (NIHR133712) using UK aid from the UK Government to support global health research. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethical Approval for the proposed study has been obtained through the ethical review procedures of the University of Aberdeen, The University of Rwanda and Addis Ababa University I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The data sets that the project generates will be deposited with the UK National Data Archive within six months of the completion of the project under a Creative Commons Attribution 4.0 Unported (CC BY 4.0) license.