Prevention of Child Mental Health Problems in Southeastern Europe

NCT03552250 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2018-12-04

No results posted yet for this study

Summary

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).

Conditions

  • Child Mental Disorder

Interventions

BEHAVIORAL

Parenting for Lifelong Health for Young Children

In this study, the 12 sessions-PLH version for parents of young children (2-9 years) will be delivered. The PLH (2 - 9) programme is delivered in groups of parents and includes the following general content 1) One-on-one time, 2) Say what you see, 3) Talking about feelings, 4) Praising and rewarding our children, 5) Giving positive, specific, and realistic instructions, 6) Establishing household rules and routines, 7) Redirecting negative behavior, 8) Ignoring negative attention seeking and demanding behavior, 9) Using consequences to support compliance, 10) Using Cool-down as a consequence for aggressive behavior, 11) Avoiding and resolving conflicts, 12) Reflection celebration, and moving on.

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
  • Technische Universitaet Braunschweig

    lead OTHER

Principal Investigators

  • Heather Foran, Prof. · Adria-Adria-University Klagenfurt

  • Jamie Lachman, Dr. · University of Oxford

  • Frances Gardner, Prof. · University of Oxford

  • Judy Hutchings, Prof. · Bangor University

  • Adriana Baban, Prof. · Babes Boylai University

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

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

  • Catherine Ward, Prof. · University of Cape Town

  • Xiangming Fang, Prof. · Georgia State University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-26
Primary Completion
2018-11-19
Completion
2018-12-02

Countries

  • Moldova
  • North Macedonia
  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03552250 on ClinicalTrials.gov