Randomized Controlled Trial of a Family-focused Intervention for Caregivers and Young Adolescents (Phase 3 of FLOURISH)
NCT ID: NCT07240571
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1280 participants
INTERVENTIONAL
2025-10-24
2026-06-30
Brief Summary
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Detailed Description
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Building on prior research, the Family-Focused Adolescent \& Lifelong Health Promotion (FLOURISH) project aims to adapt, optimize, and evaluate a parenting intervention for adolescents aged 10-14 and their caregivers in North Macedonia and Moldova. The project focuses on improving adolescent mental health and well-being in both teens and caregivers, and it is implemented according to the Multiphase Optimization Strategy (MOST) framework.
Phase 1 of the project assessed the feasibility and cultural adaptation of the PLH for Parents and Teens program. In Phase 2, a multi-country factorial trial tested different combinations of three additional components (adolescent mental health tools from UNICEF's Helping Adolescents Thrive comics, adolescent peer support, and engagement boosters) and identified the optimized intervention package.
This protocol describes the evaluation (Phase 3) of the optimized FLOURISH intervention package. The randomized waitlist controlled trial will recruit adolescent-caregiver pairs (320 to 340 families per country, 640 to 660 total) to test the effectiveness, cost-effectiveness, and scalability of the optimized PLH program. Families assigned to the intervention group will receive the program over seven weeks (one pre-program visit and six weekly group sessions), while families in the waitlist control group will receive the intervention after the six-month follow-up assessment. The results of this study will inform the potential for scaling up the optimized intervention at the national level in both countries and contribute robust evidence on adolescent mental health promotion in LMICs.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Optimized Parenting for Lifelong Health (PLH) for Parents and Teens
Families assigned to this arm will receive the optimized Parenting for Lifelong Health (PLH) for Parents and Teens program. The intervention is delivered in groups of approximately 10 adolescent-caregiver pairs over a 7-week period. It includes one pre-program visit and six weekly group sessions (about two hours each), with a mix of joint and separate sessions for caregivers and adolescents. Sessions are facilitated by trained professionals under ongoing supervision to ensure fidelity. The program focuses on strengthening family relationships, improving communication, managing emotions, problem-solving, and promoting positive parenting.
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.
Waitlist Control
Families assigned to this arm will not receive the intervention during the initial study period. They will complete all study assessments at baseline, post-intervention, and 6-month follow-up. After completion of the 6-month follow-up assessment, families in the waitlist control arm will be offered the optimized Parenting for Lifelong Health (PLH) for Parents and Teens program under the same delivery format as the intervention group.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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.
10 Years
14 Years
ALL
Yes
Sponsors
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Health for Youth Association, Moldova
OTHER
Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
OTHER
Cardiff University
OTHER
Medical University of Vienna
OTHER
Bielefeld University
OTHER
University Jaume I Castellon
UNKNOWN
Association of Systemic Therapists Education Centre
UNKNOWN
University of Klagenfurt
OTHER
Responsible Party
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Principal Investigators
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Heather M Foran, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Klagenfurt
Yulia Shenderovich, Dr
Role: PRINCIPAL_INVESTIGATOR
Cardiff University
Marija Raleva
Role: PRINCIPAL_INVESTIGATOR
Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
Galina Dr Lesco
Role: PRINCIPAL_INVESTIGATOR
Health for Youth Association, Moldova
Graham Moore, Prof
Role: PRINCIPAL_INVESTIGATOR
Cardiff University
Rhiannon Evans, Prof
Role: PRINCIPAL_INVESTIGATOR
Cardiff University
Judit Simon, Prof
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Nina Heinrichs, Prof
Role: PRINCIPAL_INVESTIGATOR
Bielefeld University
Nevena Calovska, Prof
Role: PRINCIPAL_INVESTIGATOR
Association of Systemic Therapists Education Centre
Bojan Shimbov, Prof
Role: PRINCIPAL_INVESTIGATOR
University Jaume
Locations
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Health For Youth Association
Chisinau, , Moldova
Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
Skopje, , North Macedonia
Countries
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Central Contacts
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Facility Contacts
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Viorel Babii
Role: backup
Slavica Gajdadzis-Knezhevikj, Dr.
Role: backup
Other Identifiers
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20230135
Identifier Type: -
Identifier Source: org_study_id
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