Prevention of Child Mental Health Problems in Southeastern Europe (RISE) - A Factorial Study (Phase 2 of MOST)

Summary

The aim of this study is to optimize an adapted version of a parenting program, Parenting for Lifelong Health for Young Children (PLH), to meet the specific needs of families in three low- and middle-income countries in Southeastern Europe (Romania, FYR of Macedonia and Republic of Moldova) using a cluster factorial experimental design to select the most efficacious, cost-effective, and scalable intervention components. This study is the second phase of a three-phase research project (www.rise-plh.eu).

The cluster factorial experiment will examine the effectiveness, cost-effectiveness, and implementation of three selected components of the PLH for Children program to inform the selection of the most effective, cost-effective, and implementable components to include in a prevention package prior to testing it in a subsequent RCT. The cluster factorial experiment will be conducted across three Southeastern European country sites. Each site will recruit families with children aged two to nine years who have elevated levels of child behavior problems, including specifically high-risk groups, such as minorities (e.g. Roma families). Program facilitators will be recruited from local agencies and schools. The factorial experimental trial will randomize 16 clusters in each country to one of 8 experimental conditions which consist of any combination of the three components (program length: 5 sessions/10 sessions; engagement booster: high/low; fidelity booster: high supervision/low supervision). The purpose of this factorial experiment is to estimate the main effects of the three intervention components and interactions between the components.

At the end of the cluster factorial experiment, we will develop an optimized version of the program by selecting components or component levels that have the highest level of effectiveness as based on effect size (rather than p-values). We will also take into consideration factors regarding cost-effectiveness and implementation outcomes when designing this optimized intervention package.

Conditions

• Child Mental Disorder

Interventions

BEHAVIORAL

Parenting for Lifelong Health (PLH)

The Parenting for Lifelong Health (PLH) initiative is focused on the development, evaluation, and dissemination of parenting programs to reduce violence against children and improve child wellbeing in LMIC. It was established to address the need to develop low-cost, evidence-based parenting programs that can be integrated within existing service delivery systems in LMIC. The PLH for Young Children from 2-9 y. (PLH 2-9) program includes general content like one-on-one time/child-led play; praising and rewarding children; instructions, household rules, and routines; managing difficult behaviours: ignore and consequences; reflection and moving on. Core activities during sessions include group discussions illustrated vignettes, role-plays, collaborative problem solving, practicing skills at home.

Sponsors & Collaborators

• University of Klagenfurt

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• Bangor University

  collaborator OTHER

• Babes-Bolyai University

  collaborator OTHER

• Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

  collaborator OTHER

• Health for Youth Association, Moldova

  collaborator OTHER

• University of Cape Town

  collaborator OTHER

• Georgia State University

  collaborator OTHER

• University of Bremen

  lead OTHER

Principal Investigators

• Heather Foran, Prof. · University of Klagenfurt

• Jamie Lachman, Dr. · University of Oxford

• Frances Gardner, Prof. · University of Oxford

• Judy Hutchings, Prof. · Bangor University

• Adriana Baban, Prof. · Babes Boylai University

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

• Galina Lesco, Dr. · Health for Youth Association, Moldova

• Catherine Ward, Prof. · University of Cape Town

• Xiangming Fang, Prof. · Georgia State University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-01

Primary Completion

2020-05-10

Completion

2020-05-10

Countries

• Moldova
• North Macedonia
• Romania

Study Locations