Family-focused intervention programme to foster adolescent mental health and well-being: protocol for a multicountry cluster randomised factorial trial (FLOURISH Phase 2)
Introduction Adolescent mental health problems represent a significant global health issue, particularly in low- and middle-income countries, such as the Republic of North Macedonia and the Republic of Moldova. Effective and scalable interventions are urgently needed to address these challenges.Meth...
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BMJ Publishing Group
2025-02-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/2/e094085.full |
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| author | Heather M Foran Marija Raleva Nina Heinrichs Graham Moore Yulia Shenderovich Xiang Zhao Judith Simon Antonio Piolanti Viorel Babii Janina Mueller Franziska Waller Dennis Wienand Swetha Sampathkumar Ivo Kunovski |
| author_facet | Heather M Foran Marija Raleva Nina Heinrichs Graham Moore Yulia Shenderovich Xiang Zhao Judith Simon Antonio Piolanti Viorel Babii Janina Mueller Franziska Waller Dennis Wienand Swetha Sampathkumar Ivo Kunovski |
| author_sort | Heather M Foran |
| collection | DOAJ |
| description | Introduction Adolescent mental health problems represent a significant global health issue, particularly in low- and middle-income countries, such as the Republic of North Macedonia and the Republic of Moldova. Effective and scalable interventions are urgently needed to address these challenges.Methods and analysis This protocol outlines a multicountry cluster randomised factorial trial, implemented according to the multiphase optimisation strategy (Phase 2), which evaluates the effectiveness and costs of three add-on components for the Parenting for Lifelong Health for Parents and Teens programme: adolescent mental health tools based on UNICEFs Helping Adolescents Thrive comics, adolescent peer support based on UNICEFs ‘I Support My Friends’ intervention and engagement booster designed to enhance attendance and programme completion through incentives. The study will recruit 720 families and involve 64 clusters in North Macedonia and Moldova. Primary outcomes will include adolescent internalising problems and social support, family functioning and attendance during the programme. Secondary outcomes will assess broader aspects of mental health among caregivers and adolescents, as well as implementation and cost outcomes. Data will be collected at baseline and postintervention, approximately, 8 weeks later. Statistical analyses will include regression models to assess the main and interaction effects of the intervention components and cost analyses.Ethics and dissemination The study received ethical approval from the University of Klagenfurt in Austria (approval number: 2023–013), the Medical Faculty at St. Cyril and Methodius University in North Macedonia (approval number: 03-2144/4) and the National Committee of Ethical Expertise for Clinical Trials in Moldova (approval number: 1476). The results will be disseminated through peer-reviewed journals, conferences, webinars in multiple languages, regional forums, stakeholder meetings with policymakers and practitioners, public communication through media engagement and open access platforms, including data sharing and early release of findings.Trial registration details Trial registration: NCT06562244; Project page: https://www.flourish-study.org/about.html |
| format | Article |
| id | doaj-art-5849a9743c724f0f827301f743ef080c |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-5849a9743c724f0f827301f743ef080c2025-02-08T08:45:14ZengBMJ Publishing GroupBMJ Open2044-60552025-02-0115210.1136/bmjopen-2024-094085Family-focused intervention programme to foster adolescent mental health and well-being: protocol for a multicountry cluster randomised factorial trial (FLOURISH Phase 2)Heather M Foran0Marija Raleva1Nina Heinrichs2Graham Moore3Yulia Shenderovich4Xiang Zhao5Judith Simon6Antonio Piolanti7Viorel Babii8Janina Mueller9Franziska Waller10Dennis Wienand11Swetha Sampathkumar12Ivo Kunovski131 Department of Health Psychology, University of Klagenfurt, Klagenfurt, Austria7 Institute for Marriage, Family, and Systemic Practice - ALTERNATIVA, Skopje, North Macedonia2 Department of Psychology, Bielefeld University, Bielefeld, Germany5 Centre for Development, Evaluation, Complexity, and Implementation in Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, UK5 Centre for Development, Evaluation, Complexity, and Implementation in Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, UK1 Department of Health Psychology, University of Klagenfurt, Klagenfurt, Austria3 Department of Health Economics, Center for Public Health, Medical University of Vienna, Vienna, Austria1 Department of Health Psychology, University of Klagenfurt, Klagenfurt, Austria9 Asociatia Obsteasca Sanatate Pentru Tineri (Health for Youth Association), Chisinau, Republic of Moldova1 Department of Health Psychology, University of Klagenfurt, Klagenfurt, Austria1 Department of Health Psychology, University of Klagenfurt, Klagenfurt, Austria3 Department of Health Economics, Center for Public Health, Medical University of Vienna, Vienna, Austria5 Centre for Development, Evaluation, Complexity, and Implementation in Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, UK7 Institute for Marriage, Family, and Systemic Practice - ALTERNATIVA, Skopje, North MacedoniaIntroduction Adolescent mental health problems represent a significant global health issue, particularly in low- and middle-income countries, such as the Republic of North Macedonia and the Republic of Moldova. Effective and scalable interventions are urgently needed to address these challenges.Methods and analysis This protocol outlines a multicountry cluster randomised factorial trial, implemented according to the multiphase optimisation strategy (Phase 2), which evaluates the effectiveness and costs of three add-on components for the Parenting for Lifelong Health for Parents and Teens programme: adolescent mental health tools based on UNICEFs Helping Adolescents Thrive comics, adolescent peer support based on UNICEFs ‘I Support My Friends’ intervention and engagement booster designed to enhance attendance and programme completion through incentives. The study will recruit 720 families and involve 64 clusters in North Macedonia and Moldova. Primary outcomes will include adolescent internalising problems and social support, family functioning and attendance during the programme. Secondary outcomes will assess broader aspects of mental health among caregivers and adolescents, as well as implementation and cost outcomes. Data will be collected at baseline and postintervention, approximately, 8 weeks later. Statistical analyses will include regression models to assess the main and interaction effects of the intervention components and cost analyses.Ethics and dissemination The study received ethical approval from the University of Klagenfurt in Austria (approval number: 2023–013), the Medical Faculty at St. Cyril and Methodius University in North Macedonia (approval number: 03-2144/4) and the National Committee of Ethical Expertise for Clinical Trials in Moldova (approval number: 1476). The results will be disseminated through peer-reviewed journals, conferences, webinars in multiple languages, regional forums, stakeholder meetings with policymakers and practitioners, public communication through media engagement and open access platforms, including data sharing and early release of findings.Trial registration details Trial registration: NCT06562244; Project page: https://www.flourish-study.org/about.htmlhttps://bmjopen.bmj.com/content/15/2/e094085.full |
| spellingShingle | Heather M Foran Marija Raleva Nina Heinrichs Graham Moore Yulia Shenderovich Xiang Zhao Judith Simon Antonio Piolanti Viorel Babii Janina Mueller Franziska Waller Dennis Wienand Swetha Sampathkumar Ivo Kunovski Family-focused intervention programme to foster adolescent mental health and well-being: protocol for a multicountry cluster randomised factorial trial (FLOURISH Phase 2) BMJ Open |
| title | Family-focused intervention programme to foster adolescent mental health and well-being: protocol for a multicountry cluster randomised factorial trial (FLOURISH Phase 2) |
| title_full | Family-focused intervention programme to foster adolescent mental health and well-being: protocol for a multicountry cluster randomised factorial trial (FLOURISH Phase 2) |
| title_fullStr | Family-focused intervention programme to foster adolescent mental health and well-being: protocol for a multicountry cluster randomised factorial trial (FLOURISH Phase 2) |
| title_full_unstemmed | Family-focused intervention programme to foster adolescent mental health and well-being: protocol for a multicountry cluster randomised factorial trial (FLOURISH Phase 2) |
| title_short | Family-focused intervention programme to foster adolescent mental health and well-being: protocol for a multicountry cluster randomised factorial trial (FLOURISH Phase 2) |
| title_sort | family focused intervention programme to foster adolescent mental health and well being protocol for a multicountry cluster randomised factorial trial flourish phase 2 |
| url | https://bmjopen.bmj.com/content/15/2/e094085.full |
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