Prevention of Child Mental Health Problems in Southeastern Europe - Phase 3

Summary

The overall RISE project aims to adapt, optimise and test a low-cost parenting programme for families in three southeastern European countries (North Macedonia, Republic of Moldova, Romania). Therefore, the investigators apply the Multiphase Optimization Strategy (MOST) and conduct the study over 3 phases: during the first Phase (Preparation) the feasibility of the intervention and the assessment and implementation procedures were tested in a small pilot study. In the second Phase (Optimization), 8 different programme combinations were tested in order to identify the most effective and cost-effective combination in the three countries. Now, in the third Phase (Evaluation), the optimised intervention identified in Phase 2 will be tested in a randomised controlled trial. The investigators also apply dimensions of the RE-AIM framework to maximise the reach, effectiveness, adoption, implementation within the existing service infrastructure and maintained use of the new intervention.

For the current Phase 3, the investigators aim to recruit a total of 864 parents (n = 288 per country) of children with elevated child behaviour problems aged 2 to 9 years. After pre-assessment the families will be randomly assigned to the intervention group or the control group. Parents in the intervention group will receive a parenting programme (5 sessions, Parenting for Lifelong Health for Young Children, PLH-YC) and the parents in the control condition will receive one lecture on parenting (Raising Healthy Children). Parents will be asked to complete assessments after intervention completion (post-assessment) and 12 months after pre-assessment (follow-up assessment) in order to detect immediate and more longterm effects.

Conditions

• Child Mental Disorder

Interventions

BEHAVIORAL

PLH-YC

There will be 5 weekly 2-hour sessions. The optimised PLH-YC uses a participatory, non-didactic approach to engage parents. Parents learn positive parenting skills and how to manage child behaviour problems. The program includes Session 1: One-on-One Time and Say What You See, Session 2: Praise and Rewards, Session 3: Instructions, Redirect, Rules, and Routines, Session 4: Ignore and Consequences, Session 5: Reflection and Moving On. Core activities during sessions include group discussions illustrated vignettes, role-plays, collaborative problem solving, practicing skills at home.

BEHAVIORAL

Lecture

Lecture on parenting. This is a 26-slides power-point presentation that was developed by the University of Bremen for the purpose of this study. Duration: 1 to 1.5 hours. Content: 1) Stages of child development; (2) Potential risk factors for child emotional or behaviour problems; (3) Resources and protective factors; (4) Tips: What parents can do to promote children's development.

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

• Nina Heinrichs, Prof. · University of Bremen

• Heather Foran, Prof. · University of Klagenfurt

• Jamie Lachman, Dr. · University of Oxford

• Adriana Baban, Prof. · Babes-Bolyai University

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

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

• Frances Gardner, Prof. · University of Oxford

• Judy Hutchings, Prof. · Bangor University

• Catherine Ward, Prof. · University of Cape Town

• Xiangming Fang, Prof. · Georgia State University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-07

Primary Completion

2022-03-14

Completion

2022-03-14

Countries

• Moldova
• North Macedonia
• Romania

Study Locations