Randomized Controlled Trial of a Family-focused Intervention for Caregivers and Young Adolescents (Phase 3 of FLOURISH)

NCT07240571 | Recruiting DMC

• 1 other identifier: 20230135
• Study Type: interventional
• Target: 1,280
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Family Functioning; Well-Being, Psychological; Adolescent - Emotional Problem; Parent Child Relationship

Keywords

Multiphase Optimization Strategy (MOST); Family-based intervention; Adolescents; Mental health; Randomized trial

Outcome Measures

Primary Outcomes (5)

• Change in levels of emotional and behavioral problems in adolescents (caregiver report): Pediatric Symptom Checklist (PSC-17), internalizing subscale

  The PSC-17 (caregiver-report) includes 17 items, with responses from 0 (never) to 2 (often) and assesses adolescents' psychosocial functioning. The internalizing subscale includes 5 items. Higher scores indicate more emotional problems.

  Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up

• 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. It consists of 12 items. Scoring is on a 4-point scale (from 1 = strongly agree to 4 = strongly disagree). Higher scores indicate poorer family functioning.

  Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up

• Change in frequency of parenting practices in caregivers (caregiver-report): Alabama Parenting Questionnaire (APQ), subscales involved and positive parenting

  Parenting practices will be assessed with the caregiver-report version of the APQ. The APQ is a self-report measure of parenting behaviors designed to assess practices most related to children's behavioral adjustment. Items are rated on a 5-point scale from 1 (never) to 5 (always). Higher scores on the involved and positive parenting subscales indicate more positive parenting practices. It is completed by caregivers.

  Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up

• Change in caregiver health-related quality of life: EQ-5D-5L

  The EQ-5D-5L is a standardized instrument developed to measure health-related quality of life. It consists of five dimensions, each rated on a 5-point scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. Additionally, it includes a visual analogue scale (VAS) ranging from 0 (worst imaginable health) to 100 (best imaginable health). Higher dimension scores indicate more health problems; higher VAS scores indicate better self-rated health. It is completed by caregivers.

  Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up

• Change in adolescent health-related quality of life: EQ-5D-Y-3L

  The EQ-5D-Y-3L is a standardized instrument designed to measure health-related quality of life in children and adolescents. It consists of five dimensions, each rated on a 3-point scale: no problems, some problems, severe problems. It also includes a visual analogue scale (VAS) from 0 (worst imaginable health) to 100 (best imaginable health). Higher dimension scores indicate more health problems; higher VAS scores indicate better self-rated health. It is completed by adolescents.

  Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up

Secondary Outcomes (23)

• Change in levels of family communication in adolescents: Child-Parent Communication Apprehension scale (CPA-YA), total score

  Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up

• Change in levels of loneliness in adolescents: UCLA-8 Loneliness scale, total score

  Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up

• Change in frequency of parenting practices (adolescent-report): Alabama Parenting Questionnaire (APQ), subscales involved and positive parenting

  Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up

• Change in levels of emotional and behavioral problems in adolescents (adolescent-report): Pediatric Symptom Checklist (PSC-17), internalizing, externalizing and attention subscales, total score

  Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up

• Change in levels of well-being in adolescents: World Health Organization-Five Well-Being Index (WHO-5), total score

  Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up

Other Outcomes (13)

• Adolescent healthy weight: Body Mass Index (BMI), adolescent-report

  Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up

• Adolescent healthy weight: Body Mass Index (BMI), caregiver-report

  Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up

• Post-traumatic stress in caregivers: PTSD Checklist for DSM-5 (PCL-5), short form, total score

  Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up

Study Arms (2)

Optimized Parenting for Lifelong Health (PLH) for Parents and Teens

EXPERIMENTAL

Families assigned to this arm will receive the optimized Parenting for Lifelong Health (PLH) for Parents and Teens program. The intervention is delivered in groups of approximately 10 adolescent-caregiver pairs over a 7-week period. It includes one pre-program visit and six weekly group sessions (about two hours each), with a mix of joint and separate sessions for caregivers and adolescents. Sessions are facilitated by trained professionals under ongoing supervision to ensure fidelity. The program focuses on strengthening family relationships, improving communication, managing emotions, problem-solving, and promoting positive parenting.

Behavioral: Optimized Parenting for Lifelong Health (PLH) for Parents and Teens

Waitlist Control

NO INTERVENTION

Families assigned to this arm will not receive the intervention during the initial study period. They will complete all study assessments at baseline, post-intervention, and 6-month follow-up. After completion of the 6-month follow-up assessment, families in the waitlist control arm will be offered the optimized Parenting for Lifelong Health (PLH) for Parents and Teens program under the same delivery format as the intervention group.

Interventions

Optimized Parenting for Lifelong Health (PLH) for Parents and Teens BEHAVIORAL

The optimized Parenting for Lifelong Health (PLH) for Parents and Teens program is a group-based parenting and adolescent skills training intervention. It will be delivered to adolescent-caregiver pairs (ages 10-14 and their primary caregivers) in groups of about 10 families. The program lasts 7 weeks and includes one pre-program visit and six weekly group sessions of approximately two hours each. Sessions include both joint and separate modules for caregivers and adolescents, focusing on building positive relationships, managing emotions, establishing routines, problem solving, and strengthening family communication. The program is facilitated by trained professionals who receive two days of training and ongoing weekly supervision.

Optimized Parenting for Lifelong Health (PLH) for Parents and Teens

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Health for Youth Association, Moldova: collaborator
• Institute for Marriage, Family and Systemic Practice - ALTERNATIVA: collaborator
• Medical University of Vienna: collaborator
• Bielefeld University: collaborator
• University Jaume I Castellon: collaborator
• Association of Systemic Therapists Education Centre: collaborator
• University of Klagenfurt: lead
• Cardiff University: collaborator

Study Sites (2)

Health For Youth Association

Chisinau, Moldova

RECRUITING

Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

Skopje, North Macedonia

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Heather M Foran, Prof

  University of Klagenfurt

  PRINCIPAL INVESTIGATOR

• Yulia Shenderovich, Dr

  Cardiff University

  PRINCIPAL INVESTIGATOR

• Marija Raleva

  Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

  PRINCIPAL INVESTIGATOR

• Galina Dr Lesco

  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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather M Foran, Prof

CONTACT

+4346027001641; heather.foran@aau.at

Antonio Piolanti, Dr

CONTACT

antonio.piolanti@aau.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 21, 2025
• Study Start: October 24, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

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

Locations

MO (1); NO (1)