Randomized Controlled Trial of a Family-focused Intervention for Caregivers and Young Adolescents (Phase 3 of FLOURISH)
Family-Focused Adolescent & Lifelong Health Promotion: Prevention of Adolescent Mental Health Problems in Eastern Europe
University of Klagenfurt
1,280 participants
Oct 24, 2025
INTERVENTIONAL
Conditions
Summary
The aim of this study is to conduct a multi-country randomized waitlist controlled trial to evaluate the effectiveness, cost-effectiveness, and scalability of the optimized Parenting for Lifelong Health (PLH) for Parents and Teens program in Moldova and North Macedonia. In Phase 2 of the FLOURISH project, a factorial trial tested multiple intervention components and identified the optimized intervention package. In Phase 3, this trial will assess the implementation, outcomes, and economic impact of the optimized PLH program delivered to adolescents aged 10-14 and their caregivers. ALTERNATIVA will deliver the program in North Macedonia and the Health for Youth Association in the Republic of Moldova.
Eligibility
Inclusion Criteria9
- For Caregivers:
- Must be 18 years or older at 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 (e.g., Macedonian, Romanian, Russian, Ukrainian or Albanian)
- Must agree to participate in the program and provide informed consent for both themselves and their adolescent
- For Adolescents:
- Must be aged 10-14 at the baseline assessment
- Must provide assent to participate in the study
- Must have caregiver consent to participate.
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Interventions
The optimized Parenting for Lifelong Health (PLH) for Parents and Teens program is a group-based parenting and adolescent skills training intervention. It will be delivered to adolescent-caregiver pairs (ages 10-14 and their primary caregivers) in groups of about 10 families. The program lasts 7 weeks and includes one pre-program visit and six weekly group sessions of approximately two hours each. Sessions include both joint and separate modules for caregivers and adolescents, focusing on building positive relationships, managing emotions, establishing routines, problem solving, and strengthening family communication. The program is facilitated by trained professionals who receive two days of training and ongoing weekly supervision.
Locations(2)
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NCT07240571