Family-Focused Adolescent &Amp; Lifelong Health Promotion Optimization Trial (NCT06562244) | Clinical Trial Compass
CompletedNot Applicable
Family-Focused Adolescent &Amp; Lifelong Health Promotion Optimization Trial
North Macedonia1,316 participantsStarted 2024-10-21
Plain-language summary
The aim of this study is to conduct a multi-country, cluster-randomized factorial trial to optimize the Parenting for Lifelong Health (PLH) for Parents and Teens program in Moldova and North Macedonia. Specifically, this trial will evaluate the effectiveness and cost consequences of three additional intervention components: UNICEF's Helping Adolescents Thrive comics, adolescent peer support based on UNICEF's I Support My Friends intervention, and engagement boosters.
ALTERNATIVA will deliver the program in North Macedonia and Health for Youth Association in the Republic of Moldova.
This trial is implemented according to the Multiphase Optimization Strategy (MOST). MOST involves three phases. The preparation phase involves adapting and piloting the intervention (Phase 1). The optimization phase involves a factorial trial (Phase 2). Finally, the evaluation phase involves conducting a randomized controlled trial to assess the optimized intervention's effectiveness and cost-effectiveness (Phase 3). A Phase 2 factorial trial is the focus of this registration.
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 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.
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 caregiver-reported emotional problems in adolescents: Child Behavior Checklist (CBCL) 6-18, "internalizing subscale"
Timeframe: Pre-assessment and 6 - 8 weeks after pre-assessment
2
Change in levels of social support in adolescents: Medical Outcome Study Social Support Survey (MOS-SSS), "emotional support subscale", and Kidscreen-52, "peer and social support subscale"
Timeframe: Pre-assessment and 6 - 8 weeks after pre-assessment
3
Change in levels of family functioning in caregivers: Family Assessment Device (FAD), subscale "general functioning"
Timeframe: Pre-assessment and 6 - 8 weeks after pre-assessment
4
Attendance rate
Timeframe: During the implementation of the intervention (6 - 8 weeks)