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

NCT07240571 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1280

Last updated 2025-11-21

No results posted yet for this study

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

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

Interventions

BEHAVIORAL

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

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.

Sponsors & Collaborators

  • Health for Youth Association, Moldova

    collaborator OTHER
  • Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

    collaborator OTHER
  • Cardiff University

    collaborator OTHER
  • Medical University of Vienna

    collaborator OTHER
  • Bielefeld University

    collaborator OTHER
  • University Jaume I Castellon

    collaborator UNKNOWN
  • Association of Systemic Therapists Education Centre

    collaborator UNKNOWN
  • University of Klagenfurt

    lead OTHER

Principal Investigators

  • Heather M Foran, Prof · University of Klagenfurt

  • Yulia Shenderovich, Dr · Cardiff University

  • Marija Raleva · Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

  • Galina Dr Lesco · Health for Youth Association, Moldova

  • Graham Moore, Prof · Cardiff University

  • Rhiannon Evans, Prof · Cardiff University

  • Judit Simon, Prof · Medical University of Vienna

  • Nina Heinrichs, Prof · Bielefeld University

  • Nevena Calovska, Prof · Association of Systemic Therapists Education Centre

  • Bojan Shimbov, Prof · University Jaume

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-24
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Moldova
  • North Macedonia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07240571 on ClinicalTrials.gov