Family-Focused Adolescent &Amp; Lifelong Health Promotion Optimization Trial
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)
University of Klagenfurt
640 participants
Oct 21, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The PLH program is the core intervention and will be delivered over 6 sessions with adolescents and caregivers, focusing on building positive parent-child relationships, problem-solving skills, stress management, effective limit-setting, and emotional regulation. There will also be a pre-program visit with the facilitator and families prior to the group sessions. Sessions will include both separate and joint activities between adolescents and caregivers. Engagement boosters will be provided during the PLH sessions and are part of the PLH intervention.
UNICEF's Helping Adolescents Thrive (HAT) comics will be used to guide adolescents through content on improving relationships, handling conflict, understanding emotions, and problem solving. These sessions will be group-based and cover the content in the HAT manual with the adolescents in an interactive format.
An adapted version of UNICEF's "I Support My Friends" program will be provided to adolescents by a facilitator in a group-based workshop format over the course of 1 day.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06562244