Family-Focused Adolescent &Amp; Lifelong Health Promotion Optimization Trial
FLOURISH
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)
1 other identifier
interventional
640
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2024
CompletedFirst Posted
Study publicly available on registry
August 20, 2024
CompletedStudy Start
First participant enrolled
October 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedDecember 6, 2024
December 1, 2024
7 months
August 16, 2024
December 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in levels of caregiver-reported emotional problems in adolescents: Child Behavior Checklist (CBCL) 6-18, "internalizing subscale"
The CBCL is an instrument from the Achenbach System of Empirically Based Assessment (ASEBA). Each problem item is rated 0=not true, 1=somewhat or sometimes true, and 2=very true or often true. Standardized scores can be computed with higher scores indicating more problems.
Pre-assessment and 6 - 8 weeks after pre-assessment
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"
The MOS-SSS includes 18 items with a response range from 1 (none of the time) to 5 (all of the time). The emotional support scale comprises 8 items. The Kidscreen-52, peers and social support subscale, includes 6 items with a response range from 1 (never) to 5 (always). This subscale assesses the quality of the child's relationships with peers and the support they receive from their social network.
Pre-assessment and 6 - 8 weeks after pre-assessment
Change in levels of family functioning in caregivers: Family Assessment Device (FAD), subscale "general functioning"
The general functioning subscale is one of the dimensions of the FAD and will be completed by caregivers. This scale has also been used as a single indicator to assess family functioning. The general functioning scale is made up of 12 items with six items that reflect healthy family functioning and the other six items reflecting unhealthy functioning. Scoring is on a 4-point scale (from 1 for strongly agree to 4 for strongly disagree) with the scoring for the negatively worded items reversed.
Pre-assessment and 6 - 8 weeks after pre-assessment
Attendance rate
Attendance will be assessed as the percentage of group PLH sessions attended out of 6 (individual attendance for adolescents and caregivers)
During the implementation of the intervention (6 - 8 weeks)
Secondary Outcomes (19)
Change in levels of family communication in adolescents: Child-Parent Communication Apprehension scale (CPA-YA), total score
Pre-assessment and 6 - 8 weeks after pre-assessment
Change in frequency of parenting practices: Alabama Parenting Questionnaire-APQ, subscale "involved parenting" and "positive parenting" (parent- and child-report), and subscale "corporal punishment" (parent-report)
Pre-Post (approximately 6 - 8 weeks after pre-assessment)
Change in levels of loneliness in adolescents: UCLA-8 Loneliness scale, total score
Pre-Post (approximately 6 - 8 weeks after pre-assessment)
Change in levels of social support in adolescents: Medical Outcome Study Social Support Survey (MOS-SSS), "affectionate subscale"
Pre-Post (approximately 6 - 8 weeks after pre-assessment)
Change in levels of well-being in adolescents and caregivers: World Health Organization-Five Well-Being Index (WHO-5), total score
Pre-Post (approximately 6 - 8 weeks after pre-assessment)
- +14 more secondary outcomes
Other Outcomes (11)
Adolescent healthy weight: BMI; adolescent and caregiver reports
Pre-assessment and 6 - 8 weeks after pre-assessment
Caregiver alcohol use: The Alcohol Use Disorder Identification Test (AUDIT), total score
Pre-assessment and 6 - 8 weeks after pre-assessment
Post-traumatic stress in caregivers: PTSD checklist for DSM-5 (PCL-5), short form, total score
Pre-assessment and 6 - 8 weeks after pre-assessment
- +8 more other outcomes
Study Arms (8)
HAT On, Peer Support On, High Engagement
EXPERIMENTALHAT 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).
HAT On, Peer Support Off, High Engagement
EXPERIMENTALHAT 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).
HAT On, Peer Support On, Low Engagement
EXPERIMENTALHAT 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.
HAT On, Peer Support Off, Low Engagement
EXPERIMENTALHAT 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.
HAT Off, Peer Support On, High Engagement
EXPERIMENTALHAT 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).
HAT Off, Peer Support Off, High Engagement
EXPERIMENTALHAT component: Off Peer Support: Off Engagement booster: High - Includes refreshments, certificates, and vouchers (10 EUR for adolescents, 5 EUR for caregivers).
HAT Off, Peer Support On, Low Engagement
EXPERIMENTALHAT 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.
HAT Off, Peer Support Off, Low Engagement
EXPERIMENTALHAT component: Off Peer Support: Off Engagement booster: Low - Refreshments and certificates
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.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Klagenfurtlead
- Institute for Marriage, Family and Systemic Practice - ALTERNATIVAcollaborator
- Cardiff Universitycollaborator
- Association for Systematic Therapy Education Centercollaborator
- Medical University of Viennacollaborator
- University Jaume I Castelloncollaborator
- Bielefeld Universitycollaborator
- Health for Youth Association, Moldovacollaborator
Study Sites (1)
Institute Alternativa
Skopje, North Macedonia
Related Publications (1)
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.
PMID: 39920046DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather M Foran, Prof
University of Klagenfurt
- PRINCIPAL INVESTIGATOR
Yulia Shenderovich, Dr
Cardiff University
- PRINCIPAL INVESTIGATOR
Marija Raleva, Prof
Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
- PRINCIPAL INVESTIGATOR
Galina Lesco, Dr.
Health for Youth Association, Moldova
- PRINCIPAL INVESTIGATOR
Graham Moore, Prof
Cardiff University
- PRINCIPAL INVESTIGATOR
Rhiannon Evans, Prof
Cardiff University
- PRINCIPAL INVESTIGATOR
Judit Simon, Prof
Medical University of Vienna
- PRINCIPAL INVESTIGATOR
Nina Heinrichs, Prof
Bielefeld University
- PRINCIPAL INVESTIGATOR
Nevena Calovska, Prof
Association of Systemic Therapists Education Centre
- PRINCIPAL INVESTIGATOR
Bojan Shimbov, Prof
University Jaume I Castellon, Spain
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2024
First Posted
August 20, 2024
Study Start
October 21, 2024
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
December 6, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- After completion of the study and publication of the main results.
- Access Criteria
- Prof. Heather Foran is responsible for data management of the FLOURISH project. For information related to data sharing, please contact her at heather.foran@aau.at
The project has a detailed data management plan (DMP) that defines data sharing procedures. The DMP was provided as a deliverable to the European Commission and is updated throughout the study funding period.