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Youth co-production for sustainable engagement and empowerment in health (YiPEE): protocol for a cluster-randomised controlled trial of an intervention for mental health promotion among adolescents in schools in Chennai, India

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posted on 2025-08-19, 11:41 authored by V Raghavan, M Niemi, M Martens, J de Man, J Åhs, GJ Melendez-Torres, F Mathews, J van Olmen, A Linnansaari, CA Laurenzi, P Absetz, F Azariah, M Sinha, U Sharma, O O’Sullivan, YN Kim, A Rajesh, S Saravanan, N Vasanthan, NP Haritha, L Willem, M Tomlinson, C King
INTRODUCTION: Adolescence is a time of rapid physical, social and psychological development and many risk factors for mental disorders have their roots in this age period. Primary prevention through school platforms has been extensively used and evaluated, but many interventions have poor uptake, high dropout and limited long-term sustainability. Mental health is a complex phenomenon and may be best supported through multicomponent interventions that more holistically consider inner, social and environmental levels. Character education-focused interventions are effective for improving adolescent psychosocial functioning and mental well-being. Therefore, an intervention that focuses on developing these strengths and is delivered within a school environment, through an adolescent-informed approach using creativity-focused components, has the potential to improve adolescent mental health and well-being. METHODS AND ANALYSIS: This protocol describes the YiPEE cluster-randomised controlled trial with concurrent mixed-methods process evaluation and economic evaluation, which aims to determine the impact of a multilevel multicomponent intervention in schools in Chennai, Tamil Nadu, India. Clusters-defined as schools which include Grades 6-8 (ages 11-16 years), will be randomised to intervention (n=15) or control (n=15). The intervention consists of: an 8-week classroom-based component, a 12-week teacher-focused component and a board comprising members from across the whole school. All children attending Grade 7 (aged 12-15) will be exposed to the classroom component, and teachers who actively teach Grade 7 will be invited to participate in the teacher component. Within schools, students for the individual-level evaluation will be included if they are: (1) aged 12-15 years; (2) currently attending Grade 7; (3) competent to give consent and (4) have a legal guardian competent of giving consent. We aim to sample a minimum of 100 students from each school (n=3000). All teachers of Grades 6-8 will be recruited for the evaluation. The primary outcome is symptoms of anxiety and depression measured using an abbreviated version of the UNICEF MMAPP tool. The primary analysis will be intention-to-treat, comparing the mean change in mental health score between baseline and endline, between intervention and control clusters. In addition, we will record school monitoring data (student attendance, student grades). Individual interviews with students and teachers, focus group discussions with school staff, and ethnographic observations will provide data for the process evaluation. For the economic evaluation, the combined direct and non-direct costs will be compared with changes in mental health in the intervention arm. ETHICS AND DISSEMINATION: The trial is approved by the Ethics Council of the Schizophrenia Research Foundation, India, with approval number EC/NEW/INST/2023/TN/0329. We plan to publish the main impact, process and economic evaluation results as academic publications in international peer-reviewed journals in 2026. TRIAL REGISTRATION NUMBER: Clinical Trials Registry-India (CTRI/2024/07/070949).

Funding

101095659

European Union Horizon Europe

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© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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  • No

Submission date

2024-10-26

Notes

This is the final version. Available on open access from BMJ Publishing Group via the DOI in this record

Journal

BMJ Open

Publisher

BMJ Publishing Group

Place published

England

Version

  • Version of Record

Language

en

FCD date

2025-06-26T13:37:32Z

FOA date

2025-06-26T13:41:42Z

Citation

Vol. 15(6), article e095671

Department

  • Public Health and Sport Sciences

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