You are here

  • Home
  • Archive
  • Volume 14, Issue 9
  • 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

Article Text

Article menu
Mental health
Protocol
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
  1. Karim Zagha1,
  2. Kerstin Konietzny1,
  3. Christian Brettschneider2,
  4. Omar Chehadi3,
  5. Angela Chehadi-Köster4,
  6. Nino Chikhradze5,
  7. Nesreen Dababneh1,
  8. Flora-Marie Hegerath5,
  9. Lisa Heller1,
  10. Alessia Dehnen6,
  11. Martina Hessbruegge6,
  12. Jürgen in der Schmitten6,
  13. Hans-Helmut König2,
  14. Julia Krasko7,
  15. Robert Kumsta7,
  16. Maike Luhmann7,
  17. Karoline Lukaschek8,
  18. Juergen Margraf1,
  19. Verena Pflug1,
  20. David Roesgen8,
  21. Andreas Sönnichsen9,
  22. Horst Christian Vollmar5,
  23. Jochen Gensichen8,
  24. Silvia Schneider1
  1. 1Faculty of Psychology, Mental Health Research and Treatment Center, Ruhr University Bochum, Bochum, Germany
  2. 2Department for Health Economics and Health Services Research, Universitatsklinikum Hamburg-Eppendorf, Hamburg, Germany
  3. 3Department of Medical Psychology and Medical Sociology, Ruhr-Universität Bochum, Bochum, Germany
  4. 4Department of Orthopedics and Trauma Surgery, Katholisches Klinikum Bochum Sankt Josef-Hospital, Bochum, Nordrhein-Westfalen, Germany
  5. 5Institute of General Practice and Family Medicine (AM RUB), Ruhr University Bochum, Bochum, Germany
  6. 6University of Duisburg-Essen Faculty of Medicine, Essen, Germany
  7. 7Faculty of Psychology, Ruhr University Bochum, Bochum, Germany
  8. 8Klinikum der Ludwig-Maximilians-Universität München, Muenchen, Germany
  9. 9Research Initiative Health for Austria, Vienna, Austria
  1. Correspondence to Karim Zagha; Karim.Zagha{at}ruhr-uni-bochum.de

Abstract

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.

  • mental health
  • general medicine (see internal medicine)
  • child protection
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2024-084080

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Supplementary materials

    • Supplementary Data

      This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

    Footnotes

    • X @DrChrisBrett, @@hcvollmar

    • Contributors SS, JG, ML, JM, CB, H-HK, RK and AS collaborated on the study design and jointly drafted the grant proposal. KZ and KK formulated the study protocol. SS is the guarantor. JG, ML, KZ, KK, HCV, KL, NC, JK, AC-K, OC and VP all made significant contributions to the implementation of the study. In terms of study coordination, SS, KK, HCV, LH and JidS played essential roles. KZ, ND, KL, NC, JK, LH and DR were instrumental in the meticulous process of data collection. F-MH, KL, DR, AD and MH supervised the process of participant recruitment. All authors reviewed and approved the final version of the manuscript. KZ is the first and corresponding author. SS is the guarantor.

    • Funding 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.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.