Family-Focused Adolescent &Amp; Lifelong Health Promotion Optimization Trial
Trial Parameters
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Brief Summary
The aim of this study is to conduct a multi-country, cluster-randomized factorial trial to optimize the Parenting for Lifelong Health (PLH) for Parents and Teens program in Moldova and North Macedonia. Specifically, this trial will evaluate the effectiveness and cost consequences of three additional intervention components: UNICEF's Helping Adolescents Thrive comics, adolescent peer support based on UNICEF's I Support My Friends intervention, and engagement boosters. ALTERNATIVA will deliver the program in North Macedonia and Health for Youth Association in the Republic of Moldova. This trial is implemented according to the Multiphase Optimization Strategy (MOST). MOST involves three phases. The preparation phase involves adapting and piloting the intervention (Phase 1). The optimization phase involves a factorial trial (Phase 2). Finally, the evaluation phase involves conducting a randomized controlled trial to assess the optimized intervention's effectiveness and cost-effectiveness (Phase 3). A Phase 2 factorial trial is the focus of this registration.
Eligibility Criteria
Inclusion Criteria: For Caregivers: Must be 18 years or older at the baseline assessment. Must be the primary caregiver of an adolescent aged 10-14 who has resided in the same household for at least four nights a week in the past month. Must be able to speak at least one of the local languages in which the program will be offered (Romanian, Macedonian). Must agree to participate in the program. Must provide consent for both themselves and their child to participate in the study. For Adolescents: Must be aged 10-14 at the baseline assessment. Must assent to participate in the study. Must have caregiver consent to participate in the study. Exclusion Criteria: No formal exclusion criteria have been established for the FLOURISH project. However, during the project introduction, the research team will guide participants through a consent form that asks whether they are currently experiencing acute distress or a mental or physical health condition that could interfere with their participatio