Randomized Controlled Trial of a Family-focused Intervention for Caregivers and Young Adolescents (Phase 3 of FLOURISH)
NCT07240571 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1280
Last updated 2025-11-21
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.
Conditions
- Adolescent - Emotional Problem
- Parent Child Relationship
- Family Functioning
- Well-Being, Psychological
Interventions
- BEHAVIORAL
-
Optimized Parenting for Lifelong Health (PLH) for Parents and Teens
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.
Sponsors & Collaborators
-
Health for Youth Association, Moldova
collaborator OTHER -
Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
collaborator OTHER -
Cardiff University
collaborator OTHER -
Medical University of Vienna
collaborator OTHER -
Bielefeld University
collaborator OTHER -
University Jaume I Castellon
collaborator UNKNOWN -
Association of Systemic Therapists Education Centre
collaborator UNKNOWN -
University of Klagenfurt
lead OTHER
Principal Investigators
-
Heather M Foran, Prof · University of Klagenfurt
-
Yulia Shenderovich, Dr · Cardiff University
-
Marija Raleva · Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
-
Galina Dr Lesco · Health for Youth Association, Moldova
-
Graham Moore, Prof · Cardiff University
-
Rhiannon Evans, Prof · Cardiff University
-
Judit Simon, Prof · Medical University of Vienna
-
Nina Heinrichs, Prof · Bielefeld University
-
Nevena Calovska, Prof · Association of Systemic Therapists Education Centre
-
Bojan Shimbov, Prof · University Jaume
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 10 Years
- Max Age
- 14 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-10-24
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
Countries
- Moldova
- North Macedonia
Study Locations
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