Randomized Controlled Trial of a Family-focused Intervention for Caregivers and Young Adolescents… (NCT07240571) | Clinical Trial Compass
RecruitingNot Applicable
Randomized Controlled Trial of a Family-focused Intervention for Caregivers and Young Adolescents (Phase 3 of FLOURISH)
Moldova, North Macedonia1,280 participantsStarted 2025-10-24
Plain-language 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.
Who can participate
Age range
10 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in levels of emotional and behavioral problems in adolescents (caregiver report): Pediatric Symptom Checklist (PSC-17), internalizing subscale
Timeframe: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
2
Change in levels of family functioning in caregivers: Family Assessment Device (FAD), subscale general functioning
Timeframe: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
3
Change in frequency of parenting practices in caregivers (caregiver-report): Alabama Parenting Questionnaire (APQ), subscales involved and positive parenting
Timeframe: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
4
Change in caregiver health-related quality of life: EQ-5D-5L
Timeframe: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
5
Change in adolescent health-related quality of life: EQ-5D-Y-3L
Timeframe: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up