Randomized Controlled Trial of a Family-focused Intervention for Caregivers and Young Adolescents (Phase 3 of FLOURISH)

Recruiting now · Not applicable

Conditions studied: Adolescent - Emotional Problem, Parent Child Relationship, Family Functioning, Well-Being, Psychological

In brief

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.

Key facts

Study ID

NCT07240571

Run by

University of Klagenfurt

People needed

1280

Starts

2025-10-24

Expected to finish

2026-11-30

Last updated by the study team

2026-06-02

Who can join

Age: 10 and older, up to 14. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Health For Youth Association — Chisinau, Moldova (enrolling)
• Institute for Marriage, Family and Systemic Practice - ALTERNATIVA — Skopje, North Macedonia (enrolling)

Full record on ClinicalTrials.gov

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