NCT03865485: RISE

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

Completed NA Last updated 19 May 2020

What this trial tests

NA trial testing Parenting for Lifelong Health (PLH) in Child Mental Disorder in 835 participants. Completed in 10 May 2020.

Timeline

1 March 2019

Primary endpoint
10 May 2020

10 May 2020

Quick facts

Lead sponsor	University of Bremen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	prevention
Enrollment	835
Start date	1 March 2019
Primary completion	10 May 2020
Estimated completion	10 May 2020
Sites	3 locations across Romania, North Macedonia, Moldova

Drugs / interventions tested

• Parenting for Lifelong Health (PLH)

Conditions studied

• Child Mental Disorder — all drugs for Child Mental Disorder →

Sponsor

University of Bremen

Who can join

18 and older, any sex, with Child Mental Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Preventing child mental health problems through parenting interventions in Southeastern Europe (RISE): Protocol for a multi-country cluster randomized factorial study.
   Lachman JM, Heinrichs N, Jansen E, Brühl A, et al · · 2019 · cited 15× · PMID 31669446 · DOI 10.1016/j.cct.2019.105855
2. Adverse event assessment in a parenting programme: experiences from a multisite randomised controlled trial.
   Frantz I, Foran HM, Lachman JM, Gardner F, et al · · 2024 · cited 1× · PMID 39154169 · DOI 10.1186/s13063-024-08357-6
3. Spillover mechanisms linking intimate partner violence and child maltreatment: a cross-sectional and longitudinal study among Eastern European mothers.
   Brühl A, Waller F, Foran HM, Jansen E, et al · · 2025 · PMID 41188856 · DOI 10.1186/s12889-025-24955-8