Family-focused program for caregivers and young adolescents — Phase 3 of FLOURISH
Family-Focused Adolescent & Lifelong Health Promotion: Prevention of Adolescent Mental Health Problems in Eastern Europe
This trial will test whether an optimized Parenting for Lifelong Health program helps adolescents aged 10–14 and their caregivers in Moldova and North Macedonia improve mental health, family relationships, and well-being compared with a waitlist group.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1280 (estimated) |
| Ages | 10 Years to 14 Years |
| Sex | All |
| Sponsor | University of Klagenfurt Academic / other |
| Locations | 2 sites (Chisinau and 1 other locations) |
| Trial ID | NCT07240571 on ClinicalTrials.gov |
What this trial studies
This is a multi-country randomized waitlist-controlled trial delivering the optimized Parenting for Lifelong Health (PLH) for Parents and Teens package to caregiver–adolescent pairs in Moldova and North Macedonia. The optimized package was selected from a prior factorial trial under the Multiphase Optimization Strategy (MOST) framework. Local partners (Health for Youth Association in Moldova and ALTERNATIVA in North Macedonia) will deliver the program and data will be collected on adolescent and caregiver mental health, parenting and family functioning, implementation outcomes, and costs. The trial includes an economic analysis to examine cost-effectiveness and considerations for scalability in low-resource settings.
Who should consider this trial
Good fit: Ideal participants are primary caregivers aged 18 or older and their adolescents aged 10–14 who live together most nights, can speak one of the local program languages, and are willing to give consent/assent to participate.
Not a fit: Those unlikely to benefit include children outside the 10–14 age range, families not resident in the study locations, or individuals currently experiencing acute severe medical or psychiatric crises that would interfere with participation.
Why it matters
Potential benefit: If successful, the program could improve adolescent mental health and caregiver well-being while offering a scalable, low-cost parenting support model for similar low-resource settings.
How similar studies have performed: Related Parenting for Lifelong Health programs have shown positive effects on parenting and child outcomes in other low- and middle-income settings, though this exact optimized package is newly tested in these countries.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * No formal exclusion criteria have been established for the FLOURISH project. However, during the study 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 participation. The decision to participate will be made by the individual. If a potential participant indicates they are unable to take part due to acute health issues, the research team will provide appropriate referrals to other services.
Where this trial is running
Chisinau and 1 other locations
- Health For Youth Association — Chisinau, Moldova (Recruiting)
- Institute for Marriage, Family and Systemic Practice - ALTERNATIVA — Skopje, North Macedonia (Recruiting)
Study contacts
- Principal investigator: Heather M Foran, Prof — University of Klagenfurt
- Study coordinator: Heather M Foran, Prof
- Email: heather.foran@aau.at
- Phone: +4346027001641
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.