Abstract

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 multi-country cluster randomized factorial trial, implemented according to the Multiphase Optimization Strategy (Phase 2), which evaluates the effectiveness and costs of three add-on components for the Parenting for Lifelong Health for Parents and Teens program: adolescent mental health tools based on UNICEF’s Helping Adolescents Thrive comics, adolescent peer support based on UNICEF’s I Support My Friends intervention, and engagement booster designed to enhance attendance and program completion through incentives. The study will recruit 720 families and involve 64 clusters in North Macedonia and Moldova. Primary outcomes will include adolescent internalizing problems and social support, family functioning, and attendance during the program. 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 post-intervention, approximately eight 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.

Registration details

Trial registration: NCT06562244; Project page: https://www.flourish-study.org/about.html