Improve Mental Health (Improve-MH) in refugee families using a culturally adapted, general practitioner-delivered psychotherapeutic intervention combined with Triple P Online parenting programme: study protocol of a multicentre randomised controlled trial

TY - JOUR

T1 - Improve Mental Health (Improve-MH) in refugee families using a culturally adapted, general practitioner-delivered psychotherapeutic intervention combined with Triple P Online parenting programme: study protocol of a multicentre randomised controlled trial

AU - Zagha, Karim

AU - Konietzny, Kerstin

AU - Brettschneider, Christian

AU - Chehadi, Omar

AU - Chehadi-Köster, Angela

AU - Chikhradze, Nino

AU - Dababneh, Nesreen

AU - Hegerath, Flora-Marie

AU - Heller, Lisa

AU - Dehnen, Alessia

AU - Hessbruegge, Martina

AU - in der Schmitten, Jürgen

AU - König, Hans-Helmut

AU - Krasko, Julia

AU - Kumsta, Robert

AU - Luhmann, Maike

AU - Lukaschek, Karoline

AU - Margraf, Juergen

AU - Pflug, Verena

AU - Roesgen, David

AU - Sönnichsen, Andreas

AU - Vollmar, Horst Christian

AU - Gensichen, Jochen

AU - Schneider, Silvia

PY - 2024/9/24

Y1 - 2024/9/24

N2 - INTRODUCTION: Germany and the European Union have experienced successive waves of refugees since 2014, resulting in over 1.6 million arrivals, including families with young children. These vulnerable populations often face xenophobia, discrimination, substandard living conditions and limited healthcare access, contributing to a high prevalence of mental health problems (MHP). Our primary goal is to proactively address MHP in refugee parents and prevent its potential impact on their children through effective early interventions. Using a low-threshold, primary care-based approach, we aim to enhance parenting skills and address parental psychopathology, creating a supportive environment for parents and children.METHODS AND ANALYSIS: In this randomised controlled trial, 188 refugee parents of 6-year-old children or younger who meet the clinical cut-off on the MHP scale will participate. They are randomly assigned to either the experimental psychotherapeutic intervention, delivered by general practitioners (10-week Improve intervention), or treatment as usual, in a ratio of 1:1. The randomisation will be masked only for outcome assessors. Improve includes face-to-face sessions with general practitioners, an interactive online parenting programme (Triple P Online) and regular protocol-based telephone calls by psychologists. Primary outcomes will assess the intervention's effects on parental and child MHP and parenting skills, with secondary outcomes including psychosocial and physical health indicators. Outcomes will be assessed at pre, post and at 3-month and 6-month follow-ups. The study is scheduled to run from February 2019 to July 2025.ETHICS AND DISSEMINATION: The project Improve-MH (application number 602) was approved by the local ethics committee of Ruhr-University of Bochum and is being conducted in accordance with the Declaration of Helsinki. The study is also conducted in full accordance with the German Data Protection Act, and the Good Clinical Practice guideline (GCP) and is sensitive to specific ethical considerations. Results will be disseminated at scientific conferences, published in peer-reviewed journals and provided to consumers of healthcare.TRIAL REGISTRATION NUMBER: The trial was prospectively registered at the German Clinical Trials Register (Deutsches Register Klinischer Studien, DRKS-ID: DRKS00019072) on 16 March 2020.

AB - INTRODUCTION: Germany and the European Union have experienced successive waves of refugees since 2014, resulting in over 1.6 million arrivals, including families with young children. These vulnerable populations often face xenophobia, discrimination, substandard living conditions and limited healthcare access, contributing to a high prevalence of mental health problems (MHP). Our primary goal is to proactively address MHP in refugee parents and prevent its potential impact on their children through effective early interventions. Using a low-threshold, primary care-based approach, we aim to enhance parenting skills and address parental psychopathology, creating a supportive environment for parents and children.METHODS AND ANALYSIS: In this randomised controlled trial, 188 refugee parents of 6-year-old children or younger who meet the clinical cut-off on the MHP scale will participate. They are randomly assigned to either the experimental psychotherapeutic intervention, delivered by general practitioners (10-week Improve intervention), or treatment as usual, in a ratio of 1:1. The randomisation will be masked only for outcome assessors. Improve includes face-to-face sessions with general practitioners, an interactive online parenting programme (Triple P Online) and regular protocol-based telephone calls by psychologists. Primary outcomes will assess the intervention's effects on parental and child MHP and parenting skills, with secondary outcomes including psychosocial and physical health indicators. Outcomes will be assessed at pre, post and at 3-month and 6-month follow-ups. The study is scheduled to run from February 2019 to July 2025.ETHICS AND DISSEMINATION: The project Improve-MH (application number 602) was approved by the local ethics committee of Ruhr-University of Bochum and is being conducted in accordance with the Declaration of Helsinki. The study is also conducted in full accordance with the German Data Protection Act, and the Good Clinical Practice guideline (GCP) and is sensitive to specific ethical considerations. Results will be disseminated at scientific conferences, published in peer-reviewed journals and provided to consumers of healthcare.TRIAL REGISTRATION NUMBER: The trial was prospectively registered at the German Clinical Trials Register (Deutsches Register Klinischer Studien, DRKS-ID: DRKS00019072) on 16 March 2020.

U2 - 10.1136/bmjopen-2024-084080

DO - 10.1136/bmjopen-2024-084080

M3 - SCORING: Journal article

VL - 14

SP - e084080

JO - BMJ OPEN

JF - BMJ OPEN

SN - 2044-6055

IS - 9

M1 - e084080

ER -