Family-Focused Adolescent &Amp; Lifelong Health Promotion Optimization Trial

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.

Conditions

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

  collaborator OTHER

• Cardiff University

  collaborator OTHER

• Association for Systematic Therapy Education Center

  collaborator UNKNOWN

• Medical University of Vienna

  collaborator OTHER

• University Jaume I Castellon

  collaborator UNKNOWN

• Bielefeld University

  collaborator OTHER

• Health for Youth Association, Moldova

  collaborator OTHER

• University of Klagenfurt

  lead OTHER

Principal Investigators

• Heather M Foran, Prof · University of Klagenfurt

• Yulia Shenderovich, Dr · Cardiff University

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

• Galina Lesco, Dr. · 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 I Castellon, Spain

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

10 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-10-21

Primary Completion

2025-06-30

Completion

2025-06-30

Countries

• North Macedonia

Study Locations