Family-Focused Adolescent &Amp; Lifelong Health Promotion Optimization Trial
NCT ID: NCT06562244
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
640 participants
INTERVENTIONAL
2024-10-21
2025-06-30
Brief Summary
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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.
Detailed Description
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Building on prior research, the "Family-Focused Adolescent \& Lifelong Health Promotion" (FLOURISH) project aims to adapt, optimize, and evaluate a parenting intervention for adolescents aged 10-14 and their caregivers in North Macedonia and Moldova. The project focuses on improving adolescent mental health and well-being in both teens and caregivers, and it is implemented according to the Multiphase Optimization Strategy (MOST) framework. Phase 1 of the project assessed the feasibility of the adapted parenting intervention, which included three components to enhance participation, retention, and effectiveness. The three components were UNICEF's Helping Adolescents Thrive (HAT) comics, peer support, and engagement boosters.
This protocol describes the optimization (Phase 2) of the adapted FLOURISH intervention package which will assess the effectiveness and costs of HAT, adolescent peer support, and the engagement boosters, as well as their combinations. The factorial experiment will consist of eight conditions, stratified by country, with each condition reflecting a unique combination of the three components. The results of this study will be used to select the optimized intervention package which will be tested in a randomized trial in the next phase of the FLOURISH project (Phase 3).
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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HAT On, Peer Support On, High Engagement
HAT component: On - Two interactive sessions using UNICEF's Helping Adolescents Thrive comics, covering recognizing emotions, stress management, conflict resolution, and relationship building.
Peer Support: On - Half-day workshop from UNICEF's "I Support My Friends" program, teaching adolescents to identify distress in peers, develop listening skills, and seek additional support.
Engagement booster: High - Includes refreshments, certificates, and vouchers (10 EUR for adolescents, 5 EUR for caregivers).
Parenting for Lifelong Health for Parents and Teens (PLH)
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.
Helping Adolescents Thrive comics
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.
I Support My Friends
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.
HAT On, Peer Support Off, High Engagement
HAT component: On - Two interactive sessions using UNICEF's Helping Adolescents Thrive comics, covering recognizing emotions, stress management, conflict resolution, and relationship building.
Peer Support: Off
Engagement booster: High - Includes refreshments, certificates, and vouchers (10 EUR for adolescents, 5 EUR for caregivers).
Parenting for Lifelong Health for Parents and Teens (PLH)
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.
Helping Adolescents Thrive comics
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.
HAT On, Peer Support On, Low Engagement
HAT component: On - Two interactive sessions using UNICEF's Helping Adolescents Thrive comics, covering recognizing emotions, stress management, conflict resolution, and relationship building.
Peer Support: On - Half-day workshop from UNICEF's "I Support My Friends" program, teaching adolescents to identify distress in peers, develop listening skills, and seek additional support.
Engagement booster: Low - Refreshments and certificates.
Parenting for Lifelong Health for Parents and Teens (PLH)
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.
Helping Adolescents Thrive comics
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.
I Support My Friends
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.
HAT On, Peer Support Off, Low Engagement
HAT component: On - Two interactive sessions using UNICEF's Helping Adolescents Thrive comics, covering recognizing emotions, stress management, conflict resolution, and relationship building.
Peer Support: Off
Engagement booster: Low - Refreshments and certificates.
Parenting for Lifelong Health for Parents and Teens (PLH)
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.
Helping Adolescents Thrive comics
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.
HAT Off, Peer Support On, High Engagement
HAT component: Off
Peer Support: On - Half-day workshop from UNICEF's "I Support My Friends" program, teaching adolescents to identify distress in peers, develop listening skills, and seek additional support.
Engagement booster: High - Includes refreshments, certificates, and vouchers (10 EUR for adolescents, 5 EUR for caregivers).
Parenting for Lifelong Health for Parents and Teens (PLH)
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.
I Support My Friends
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.
HAT Off, Peer Support Off, High Engagement
HAT component: Off
Peer Support: Off
Engagement booster: High - Includes refreshments, certificates, and vouchers (10 EUR for adolescents, 5 EUR for caregivers).
Parenting for Lifelong Health for Parents and Teens (PLH)
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.
HAT Off, Peer Support On, Low Engagement
HAT component: Off
Peer Support: On - Half-day workshop from UNICEF's "I Support My Friends" program, teaching adolescents to identify distress in peers, develop listening skills, and seek additional support.
Engagement booster: Low - Refreshments and certificates.
Parenting for Lifelong Health for Parents and Teens (PLH)
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.
I Support My Friends
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.
HAT Off, Peer Support Off, Low Engagement
HAT component: Off
Peer Support: Off
Engagement booster: Low - Refreshments and certificates
Parenting for Lifelong Health for Parents and Teens (PLH)
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.
Interventions
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Parenting for Lifelong Health for Parents and Teens (PLH)
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.
Helping Adolescents Thrive comics
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.
I Support My Friends
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.
Eligibility Criteria
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Inclusion Criteria
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.
10 Years
14 Years
ALL
Yes
Sponsors
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Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
OTHER
Cardiff University
OTHER
Association for Systematic Therapy Education Center
UNKNOWN
Medical University of Vienna
OTHER
University Jaume I Castellon
UNKNOWN
Bielefeld University
OTHER
Health for Youth Association, Moldova
OTHER
University of Klagenfurt
OTHER
Responsible Party
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Principal Investigators
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Heather M Foran, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Klagenfurt
Yulia Shenderovich, Dr
Role: PRINCIPAL_INVESTIGATOR
Cardiff University
Marija Raleva, Prof
Role: PRINCIPAL_INVESTIGATOR
Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
Galina Lesco, Dr.
Role: PRINCIPAL_INVESTIGATOR
Health for Youth Association, Moldova
Graham Moore, Prof
Role: PRINCIPAL_INVESTIGATOR
Cardiff University
Rhiannon Evans, Prof
Role: PRINCIPAL_INVESTIGATOR
Cardiff University
Judit Simon, Prof
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Nina Heinrichs, Prof
Role: PRINCIPAL_INVESTIGATOR
Bielefeld University
Nevena Calovska, Prof
Role: PRINCIPAL_INVESTIGATOR
Association of Systemic Therapists Education Centre
Bojan Shimbov, Prof
Role: PRINCIPAL_INVESTIGATOR
University Jaume I Castellon, Spain
Locations
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Institute Alternativa
Skopje, , North Macedonia
Countries
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Central Contacts
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Facility Contacts
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Marija Raleva, M.D.
Role: primary
References
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Piolanti A, Mueller J, Waller F, Heinrichs N, Simon J, Shenderovich Y, Sampathkumar S, Wienand D, Raleva M, Kunovski I, Babii V, Zhao X, Moore G, Foran HM. Family-focused intervention programme to foster adolescent mental health and well-being: protocol for a multicountry cluster randomised factorial trial (FLOURISH Phase 2). BMJ Open. 2025 Feb 7;15(2):e094085. doi: 10.1136/bmjopen-2024-094085.
Other Identifiers
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1010955282
Identifier Type: -
Identifier Source: org_study_id