Optimizing a parenting program for adolescent mental health in Moldova and North Macedonia
A Family-focused Intervention Program to Foster Adolescent Mental Health and Well-being: Protocol for a Multi-country Cluster Randomized Factorial Trial (FLOURISH Phase 2)
This study is testing a parenting program in Moldova and North Macedonia to see if adding comics and peer support can help improve the mental health of adolescents aged 10-14 and their caregivers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 640 (estimated) |
| Ages | 10 Years to 14 Years |
| Sex | All |
| Sponsor | University of Klagenfurt Academic / other |
| Locations | 1 site (Skopje) |
| Trial ID | NCT06562244 on ClinicalTrials.gov |
What this trial studies
This trial aims to enhance the Parenting for Lifelong Health (PLH) program by evaluating additional components such as UNICEF's Helping Adolescents Thrive comics and peer support for adolescents. Conducted in Moldova and North Macedonia, it utilizes a multi-country, cluster-randomized factorial design to assess the effectiveness and cost-effectiveness of these interventions. The study follows the Multiphase Optimization Strategy (MOST), which includes phases for preparation, optimization, and evaluation of the intervention. The goal is to improve mental health outcomes for adolescents aged 10-14 and their caregivers in low-resource settings.
Who should consider this trial
Good fit: Ideal candidates include caregivers aged 18 and older of adolescents aged 10-14 who reside together and can communicate in the local languages.
Not a fit: Patients currently experiencing acute distress or health conditions that interfere with participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve adolescent mental health and family dynamics in low-income countries.
How similar studies have performed: Previous studies have shown promise in similar family-based interventions for adolescent mental health, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: For Caregivers: Must be 18 years or older at the 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 (Romanian, Macedonian). Must agree to participate in the program. Must provide consent for both themselves and their child to participate in the study. For Adolescents: Must be aged 10-14 at the baseline assessment. Must assent to participate in the study. Must have caregiver consent to participate in the study. Exclusion Criteria: No formal exclusion criteria have been established for the FLOURISH project. However, during the project 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 their participation. The decision will be made by the potential participant. If the participant decides they are unable to take part due to acute health issues, the research team will follow up and provide referrals to other services.
Where this trial is running
Skopje
- Institute 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: +4346327001641
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.