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-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 c.pdf
child protection; general medicine (see internal medicine); mental health; Child; Female; Humans; General Practitioners; Germany; Mental Disorders/therapy; Mental Health; Multicenter Studies as Topic; Parents/psychology; Parents/education; Psychotherapy/methods; Randomized Controlled Trials as Topic; Parenting; Refugees/psychology; Mental Disorders; Parents; Psychotherapy; Refugees; Medicine (all)
Résumé :
[en] [en] 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.
Disciplines :
Neurosciences & comportement
Auteur, co-auteur :
Zagha, Karim ; Faculty of Psychology, Mental Health Research and Treatment Center, Ruhr University Bochum, Bochum, Germany Karim.Zagha@ruhr-uni-bochum.de
Konietzny, Kerstin; Faculty of Psychology, Mental Health Research and Treatment Center, Ruhr University Bochum, Bochum, Germany
Brettschneider, Christian ; Department for Health Economics and Health Services Research, Universitatsklinikum Hamburg-Eppendorf, Hamburg, Germany
Chehadi, Omar; Department of Medical Psychology and Medical Sociology, Ruhr-Universität Bochum, Bochum, Germany
Chehadi-Köster, Angela; Department of Orthopedics and Trauma Surgery, Katholisches Klinikum Bochum Sankt Josef-Hospital, Bochum, Nordrhein-Westfalen, Germany
Chikhradze, Nino; Institute of General Practice and Family Medicine (AM RUB), Ruhr University Bochum, Bochum, Germany
Dababneh, Nesreen; Faculty of Psychology, Mental Health Research and Treatment Center, Ruhr University Bochum, Bochum, Germany
Hegerath, Flora-Marie; Institute of General Practice and Family Medicine (AM RUB), Ruhr University Bochum, Bochum, Germany
Heller, Lisa; Faculty of Psychology, Mental Health Research and Treatment Center, Ruhr University Bochum, Bochum, Germany
Dehnen, Alessia; University of Duisburg-Essen Faculty of Medicine, Essen, Germany
Hessbruegge, Martina; University of Duisburg-Essen Faculty of Medicine, Essen, Germany
In der Schmitten, Jürgen; University of Duisburg-Essen Faculty of Medicine, Essen, Germany
König, Hans-Helmut ; Department for Health Economics and Health Services Research, Universitatsklinikum Hamburg-Eppendorf, Hamburg, Germany
Krasko, Julia; Faculty of Psychology, Ruhr University Bochum, Bochum, Germany
KUMSTA, Robert ; University of Luxembourg > Faculty of Humanities, Education and Social Sciences (FHSE) > Department of Behavioural and Cognitive Sciences (DBCS) > Health and Behaviour ; Faculty of Psychology, Ruhr University Bochum, Bochum, Germany
Luhmann, Maike; Faculty of Psychology, Ruhr University Bochum, Bochum, Germany
Lukaschek, Karoline; Klinikum der Ludwig-Maximilians-Universität München, Muenchen, Germany
Margraf, Juergen; Faculty of Psychology, Mental Health Research and Treatment Center, Ruhr University Bochum, Bochum, Germany
Pflug, Verena; Faculty of Psychology, Mental Health Research and Treatment Center, Ruhr University Bochum, Bochum, Germany
Roesgen, David; Klinikum der Ludwig-Maximilians-Universität München, Muenchen, Germany
Sönnichsen, Andreas; Research Initiative Health for Austria, Vienna, Austria
Vollmar, Horst Christian ; Institute of General Practice and Family Medicine (AM RUB), Ruhr University Bochum, Bochum, Germany
Gensichen, Jochen; Klinikum der Ludwig-Maximilians-Universität München, Muenchen, Germany
Schneider, Silvia; Faculty of Psychology, Mental Health Research and Treatment Center, Ruhr University Bochum, Bochum, Germany
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.
This study is funded by the German Federal Ministry of Education and Research, grant number 01EF1801A. The funding source has no role in study design, data collection, analysis and interpretation of the data, or the writing and publication of results.
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