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
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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. / Zagha, Karim; Konietzny, Kerstin; Brettschneider, Christian; Chehadi, Omar; Chehadi-Köster, Angela; Chikhradze, Nino; Dababneh, Nesreen; Hegerath, Flora-Marie; Heller, Lisa; Dehnen, Alessia; Hessbruegge, Martina; in der Schmitten, Jürgen; König, Hans-Helmut; Krasko, Julia; Kumsta, Robert; Luhmann, Maike; Lukaschek, Karoline; Margraf, Juergen; Pflug, Verena; Roesgen, David; Sönnichsen, Andreas; Vollmar, Horst Christian; Gensichen, Jochen; Schneider, Silvia.
In: BMJ OPEN, Vol. 14, No. 9, e084080, 24.09.2024, p. e084080.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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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 -