Protocol for process evaluation of ARTEMIS cluster randomised controlled trial: an intervention for management of depression and suicide among adolescents living in slums in India

IntroductionThere are around 250 million adolescents (10–19 years) in India. The prevalence of mental health-related morbidity among adolescents in India is approximately 7.3%. Vulnerable subpopulations among adolescents such as those living in slum communities are particularly at risk due to poor l...

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Published inBMJ open Vol. 14; no. 5; p. e081844
Main Authors Mukherjee, Ankita, Yatirajula, Sandhya Kanaka, Kallakuri, Sudha, Paslawar, Srilatha, Lempp, Heidi, Raman, Usha, Kumar, Ashok, Essue, Beverley M, Sagar, Rajesh, Singh, Renu, Peiris, David, Norton, Robyn, Thornicroft, Graham, Maulik, Pallab Kumar
Format Journal Article
LanguageEnglish
Published England British Medical Journal Publishing Group 20.05.2024
BMJ Publishing Group LTD
BMJ Publishing Group
SeriesProtocol
Subjects
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ISSN2044-6055
2044-6055
DOI10.1136/bmjopen-2023-081844

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Summary:IntroductionThere are around 250 million adolescents (10–19 years) in India. The prevalence of mental health-related morbidity among adolescents in India is approximately 7.3%. Vulnerable subpopulations among adolescents such as those living in slum communities are particularly at risk due to poor living conditions, financial difficulty and limited access to support services. Adolescents’ Resilience and Treatment nEeds for Mental Health in Indian Slums (ARTEMIS) is a cluster randomised controlled trial of an intervention that intends to improve the mental health of adolescents living in slum communities in India. The aim of this paper is to describe the process evaluation protocol for ARTEMIS trial. The process evaluation will help to explain the intervention outcomes and understand how and why the intervention worked or did not work. It will identify contextual factors, intervention barriers and facilitators and the adaptations required for optimising implementation.MethodsCase study method will be used and the data will include a mix of quantitative metrics and qualitative data. The UK Medical Research Council’s guidance on evaluating complex interventions, the Reach, Efficacy, Adoption, Implementation and Maintenance Framework and the Affordability, Practicability, Effectiveness and cost-effectiveness, Acceptability, Safety/Side Effects and, Equity criteria will be used to develop a conceptual framework and a priori codes for qualitative data analysis. Quantitative data will be analysed using descriptive statistics. Implementation fidelity will also be measured.DiscussionThe process evaluation will provide an understanding of outcomes and causal mechanisms that influenced any change in trial outcomes.Ethics and disseminationEthics Committee of the George Institute for Global Health India (project number 17/2020) and the Research Governance and Integrity Team, Imperial College, London (ICREC reference number: 22IC7718) have provided ethics approval. The Health Ministry’s Screening Committee has approved to the study (ID 2020-9770).Trial registration numberCTRI/2022/02/040307.
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ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2023-081844