NCT03552250: RISE

Prevention of Child Mental Health Problems in Southeastern Europe

Completed NA Last updated 4 December 2018

What this trial tests

NA trial testing Parenting for Lifelong Health for Young Children in Child Mental Disorder in 140 participants. Completed in 2 December 2018.

Timeline

26 April 2018

Primary endpoint
19 November 2018

2 December 2018

Quick facts

Lead sponsor	Technische Universitaet Braunschweig
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	140
Start date	26 April 2018
Primary completion	19 November 2018
Estimated completion	2 December 2018
Sites	3 locations across Romania, North Macedonia, Moldova

Drugs / interventions tested

• Parenting for Lifelong Health for Young Children

Conditions studied

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

Sponsor

Technische Universitaet Braunschweig

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 develop an adapted version of a low-cost parenting program (Parenting for Lifelong Health for Young Children, PLH) to the specific needs of families in three low- and middle income countries (LMICs) in southeastern Europe (Romania, FYR of Macedonia and Republic of Moldova). The investigators want systematically evaluate key barriers and facilitators at the local, national and international levels that impact prevention of child behavioral disorders.

The investigators will prepare training materials adapted to Romanian, Moldovian, Albanian, Macedonian, and Russian and train facilitators and mentor coaches in the delivery of the PLH program in each country. Also, a pre-post study will be conducted testing the feasibility of the program and the evaluation and implementation methods with 40 families at each country site. This includes examination of outcomes related to implementation fidelity, program acceptability, and preliminary program effectiveness on reducing child behavior problems and associated risk factors.

This feasibility study is part of a larger implementation project. Developed on the MOST framework (the multiphase optimization strategy), this specific study will reflect the implementation of the first phase. There are two more phases to come: the Parenting for Lifelong Health for Young Children program will be optimized within the three countries by determining which components are most efficacious and cost-effective (phase 2). The optimized PLH programs will be tested in three RCTS in the countries (phase 3).

Publications & conference data

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

1. Prevention of child mental health problems in Southeastern Europe: a multicentre sequential study to adapt, optimise and test the parenting programme 'Parenting for Lifelong Health for Young Children', protocol for stage 1, the feasibility study.
   Frantz I, Foran HM, Lachman JM, Jansen E, et al · · 2019 · cited 10× · PMID 30782760 · DOI 10.1136/bmjopen-2018-026684
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