Preventing child mental health problems through parenting interventions in Southeastern Europe (RISE): Protocol for a multi-country cluster randomized factorial study

Jamie M Lachman; Nina Heinrichs; Elena Jansen; Antonia Brühl; Diana Taut; Xiangming Fang; Frances Gardner; Judy Hutchings; Catherine L Ward; Margiad Elen Williams; Marija Raleva; Adriana Båban; Galina Lesco; Heather M Foran

doi:10.1016/j.cct.2019.105855

Preventing child mental health problems through parenting interventions in Southeastern Europe (RISE): Protocol for a multi-country cluster randomized factorial study

Contemp Clin Trials. 2019 Nov:86:105855. doi: 10.1016/j.cct.2019.105855. Epub 2019 Oct 24.

Authors

Affiliations

¹ Centre for Evidence-Based Intervention, Department of Social Policy and Intervention, University of Oxford, Oxford, UK; MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK. Electronic address: jamie.lachman@spi.ox.ac.uk.
² Department of Psychology, Clinical Psychology, and Psychotherapy, University of Bremen, Bremen, Germany.
³ Institute for Psychology, Alpen-Adria-University Klagenfurt, Klagenfurt, Austria.
⁴ Department of Psychology, Babeș-Bolyai University, Cluj-Napoca, Romania.
⁵ School of Public Health, Georgia State University, Atlanta, GA, USA.
⁶ Centre for Evidence-Based Intervention, Department of Social Policy and Intervention, University of Oxford, Oxford, UK.
⁷ Centre for Evidence Based Early Intervention, School of Psychology, Bangor University, Bangor, UK.
⁸ Department of Psychology, University of Cape Town, Cape Town, South Africa.
⁹ Institute for Marriage, Family and Systemic Practice - ALTERNATIVA, Skopje, North Macedonia.
¹⁰ Health for Youth Association, Chișinău, Republic of Moldova.

PMID: 31669446
DOI: 10.1016/j.cct.2019.105855

Abstract

Background: Child mental health problems continue to be a major global concern, especially in low- and middle-income countries (LMICs). Parenting interventions have been shown to be effective for reducing child behavior problems in high-income countries, with emerging evidence supporting similar effects in LMICs. However, there remain substantial barriers to scaling up evidence-based interventions due to limited human and financial resources in such countries.

Methods: This protocol is for a multi-center cluster randomized factorial trial of an evidence-based parenting intervention, Parenting for Lifelong Health for Young Children, for families with children ages 2-9 years with subclinical levels of behavior problems in three Southeastern European countries, Republic of Moldova, North Macedonia, and Romania (8 conditions, 48 clusters, 864 families, 108 per condition). The trial will test three intervention components: length (5 vs. 10 sessions), engagement (basic vs. enhanced package), and fidelity (on-demand vs. structured supervision). Primary outcomes are child aggressive behavior, dysfunctional parenting, and positive parenting. Analyses will examine the main effect and cost-effectiveness of each component, as well as potential interaction effects between components, in order to identify the most optimal combination of program components.

Discussion: This study is the first factorial experiment of a parenting program in LMICs. Findings will inform the subsequent testing of the optimized program in a multisite randomized controlled trial in 2021.

Trial registration: NCT03865485 registered in ClinicalTrials.gov on March 5, 2019.

Keywords: Child behavior problems; Cost-effectiveness; Factorial; Optimization; Parenting.

Publication types

Clinical Trial
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Child
Child Behavior Disorders / therapy*
Child, Preschool
Cost-Benefit Analysis
Europe
Health Education / economics
Health Education / organization & administration*
Humans
Parenting*
Parents / education*

Associated data

ClinicalTrials.gov/NCT03865485