NCT04721730: RISE

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

Completed NA Last updated 22 March 2022

What this trial tests

NA trial testing PLH-YC in Child Mental Disorder in 823 participants. Completed in 14 March 2022.

Timeline

7 December 2020

Primary endpoint
14 March 2022

14 March 2022

Quick facts

Lead sponsor	University of Bremen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	823
Start date	7 December 2020
Primary completion	14 March 2022
Estimated completion	14 March 2022
Sites	3 locations across Romania, North Macedonia, Moldova

Drugs / interventions tested

• PLH-YC
• Lecture

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 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.

Publications & conference data

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

1. Primary-level and community worker interventions for the prevention of mental disorders and the promotion of well-being in low- and middle-income countries.
   Purgato M, Prina E, Ceccarelli C, Cadorin C, et al · · 2023 · cited 17× · PMID 37873968 · DOI 10.1002/14651858.cd014722.pub2
2. Prevention of child mental health problems through parenting interventions in Southeastern Europe (RISE): study protocol for a multi-site randomised controlled trial.
   Tăut D, Băban A, Frantz I, Dănilă I, et al · · 2021 · cited 5× · PMID 34961518 · DOI 10.1186/s13063-021-05817-1
3. 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