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)
Abstract :
[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 & behavior
Author, co-author :
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.
United Nations High Commissioner for Refugees (UNHCR). n.d. Global Trends Forced Displacement in 2018. Available: https://www.unhcr.org/statistics/unhcrstats/5d08d7ee7/unhcr-global-trends-2018. html
Bundesamt für Migration und Flüchtlinge (BAMF). n.d. Aktuelle Zahlen zu Asyl (11/2022). Available: https://www.BAMF.de/SharedDocs/Anlagen/DE/Statistik/AsylinZahlen/aktuelle-zahlennovember-2022.html?nn=284722
Richter K, Lehfeld H, Niklewski G. Warten auf Asyl: Psychiatrische Diagnosen in der zentralen Aufnahmeeinrichtung in Bayern. Gesundhwesen 2015;77:834-8.
Shawyer F, Enticott JC, Block AA, et al. The mental health status of refugees and asylum seekers attending a refugee health clinic including comparisons with a matched sample of Australian-born residents. BMC Psychiatry 2017;17:76.
Huemer J, Karnik N, Voelkl-Kernstock S, et al. Psychopathology in African unaccompanied refugee minors in Austria. Child Psychiatry Hum Dev 2011;42:307-19.
Jakobsen M, Demott MAM, Heir T. Prevalence of psychiatric disorders among unaccompanied asylum-seeking adolescents in norway. Clin Pract Epidemiol Ment Health 2014;10:53-8.
Kirmayer LJ, Narasiah L, Munoz M, et al. Common mental health problems in immigrants and refugees: general approach in primary care. Can Med Assoc J 2011;183:E959-67.
World Health Organization. Mental health action plan 2013-2020. Plan d'action Global Pour La Santé Mentale 2013-2020. Geneva: World Health Organization, 2013. Available: https://iris.who.int/handle/10665/89966
Paunovic N, Ost LG. Cognitive-behavior therapy vs exposure therapy in the treatment of PTSD in refugees. Behav Res Ther 2001;39:1183-97.
Jeon S, Lee J, Jun JY, et al. The Effectiveness of Cognitive Behavioral Therapy on Depressive Symptoms in North Korean Refugees. Psychiatry Investig 2020;17:681-7.
Turrini G, Purgato M, Acarturk C, et al. Efficacy and acceptability of psychosocial interventions in asylum seekers and refugees: systematic review and meta-analysis. Epidemiol Psychiatr Sci 2019;28:376-88.
Wang PS, Aguilar-Gaxiola S, Alonso J, et al. Use of mental health services for anxiety, mood, and substance disorders in 17 countries in the WHO world mental health surveys. The Lancet 2007;370:841-50.
Namer Y, Freţian A, Podar D, et al. Asylum seeking and refugee adolescents' mental health service use and help-seeking patterns: a mixed-methods study. Npj Ment Health Res 2022;1:18.
Asfaw BB, Beiersmann C, Keck V, et al. Experiences of psychotherapists working with refugees in Germany: a qualitative study. BMC Psychiatry 2020;20:588.
Lebano A, Hamed S, Bradby H, et al. Migrants' and refugees' health status and healthcare in Europe: a scoping literature review. BMC Public Health 2020;20:1039.
Chiarenza A, Dauvrin M, Chiesa V, et al. Supporting access to healthcare for refugees and migrants in European countries under particular migratory pressure. BMC Health Serv Res 2019;19:513.
Kadir A, Battersby A, Spencer N, et al. Children on the move in Europe: a narrative review of the evidence on the health risks, health needs and health policy for asylum seeking, refugee and undocumented children. BMJ Paediatr Open 2019;3:bmjpo-2018-000364.
Nowak AC, Namer Y, Hornberg C. Health Care for Refugees in Europe: A Scoping Review. Int J Environ Res Public Health 2022;19:1278.
Radez J, Reardon T, Creswell C, et al. Why do children and adolescents (not) seek and access professional help for their mental health problems? A systematic review of quantitative and qualitative studies. Eur Child Adolesc Psychiatry 2021;30:183-211.
Biddle L, Hintermeier M, Mohsenpour A, et al. Monitoring the health and healthcare provision for refugees in collective accommodation centres: Results of the population-based survey RESPOND. J Health Monit 2021;6:7-29.
Dean K, Stevens H, Mortensen PB, et al. Full spectrum of psychiatric outcomes among offspring with parental history of mental disorder. Arch Gen Psychiatry 2010;67:822-9.
Ruf M, Schauer M, Elbert T. Prävalenz von traumatischen Stresserfahrungen und seelischen Erkrankungen bei in Deutschland lebenden Kindern von Asylbewerbern. Z Klin Psychol Psychother 2010;39:151-60.
Gäbel U, Ruf M, Schauer M, et al. Prävalenz der Posttraumatischen Belastungsstörung (PTSD) und Möglichkeiten der Ermittlung in der Asylverfahrenspraxis. Z Klin Psychol Psychother 2006;35:12-20.
Knerr W, Gardner F, Cluver L. Improving positive parenting skills and reducing harsh and abusive parenting in low- and middle-income countries: a systematic review. Prev Sci 2013;14:352-63.
Scharpf F, Kaltenbach E, Nickerson A, et al. A systematic review of socio-ecological factors contributing to risk and protection of the mental health of refugee children and adolescents. Clin Psychol Rev 2021;83:S0272-7358(20)30118-5.
Chan M. Linking child survival and child development for health, equity, and sustainable development. Lancet 2013;381:1514-5.
Lake A, Chan M. Putting science into practice for early child development. Lancet 2015;385:1816-7.
Kessler RC, Berglund P, Demler O, et al. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry 2005;62:593-602.
Shonkoff JP. Building a new biodevelopmental framework to guide the future of early childhood policy. Child Dev 2010;81:357-67.
Sanders MR, Kirby JN, Tellegen CL, et al. The Triple P-Positive Parenting Program: a systematic review and meta-analysis of a multi-level system of parenting support. Clin Psychol Rev 2014;34:337-57.
Arif A, Van Ommen C. The utility of the Positive Parenting Program (Triple P) for refugee background parents. J Fam Stud 2023;29:506-24.
van Santvoort F, Hosman CMH, Janssens JMAM, et al. The Impact of Various Parental Mental Disorders on Children's Diagnoses: A Systematic Review. Clin Child Fam Psychol Rev 2015;18:281-99.
Goodman SH, Gotlib IH. Risk for psychopathology in the children of depressed mothers: a developmental model for understanding mechanisms of transmission. Psychol Rev 1999;106:458-90.
Mattejat F, Remschmidt H. The children of mentally ill parents. Dtsch Arztebl Int 2008;105:413-8.
Garber J, Ciesla JA, McCauley E, et al. Remission of depression in parents: links to healthy functioning in their children. Child Dev 2011;82:226-43.
Pilowsky DJ, Wickramaratne P, Talati A, et al. Children of depressed mothers 1 year after the initiation of maternal treatment: findings from the STAR*D-Child Study. Am J Psychiatry 2008;165:1136-47.
Pilowsky DJ, Wickramaratne P, Poh E, et al. Psychopathology and functioning among children of treated depressed fathers and mothers. J Affect Disord 2014;164:107-11.
Weissman MM, Pilowsky DJ, Wickramaratne PJ, et al. Remissions in maternal depression and child psychopathology: a STAR*D-child report. JAMA 2006;295:1389-98.
Wickramaratne P, Gameroff MJ, Pilowsky DJ, et al. Children of depressed mothers 1 year after remission of maternal depression: findings from the STAR*D-Child study. Am J Psychiatry 2011;168:593-602.
Siegenthaler E, Munder T, Egger M. Effect of preventive interventions in mentally ill parents on the mental health of the offspring: systematic review and meta-analysis. J Am Acad Child Adolesc Psychiatry 2012;51:8-17.
Compas BE, Champion JE, Forehand R, et al. Coping and parenting: Mediators of 12-month outcomes of a family group cognitive-behavioral preventive intervention with families of depressed parents. J Consult Clin Psychol 2010;78:623-34.
Thanhäuser M, Lemmer G, de Girolamo G, et al. Do preventive interventions for children of mentally ill parents work? Results of a systematic review and meta-analysis. Curr Opin Psychiatry 2017;30:283-99.
Christiansen H, Reck C, Zietlow A-L, et al. Children of Mentally III Parents at Risk Evaluation (COMPARE): Design and Methods of a Randomized Controlled Multicenter Study-Part I. Front Psychiatry 2019;10:128.
Chronis-Tuscano A, Clarke TL, O'Brien KA, et al. Development and preliminary evaluation of an integrated treatment targeting parenting and depressive symptoms in mothers of children with attention-deficit/hyperactivity disorder. J Consult Clin Psychol 2013;81:918-25.
Day JJ, Sanders MR. Do Parents Benefit From Help When Completing a Self-Guided Parenting Program Online? A Randomized Controlled Trial Comparing Triple P Online With and Without Telephone Support. Behav Ther 2018;49:1020-38.
Sanders MR, Baker S, Turner KMT. A randomized controlled trial evaluating the efficacy of Triple P Online with parents of children with early-onset conduct problems. Behav Res Ther 2012;50:675-84.
Chan A-W, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200-7.
Popp L, Schneider S. Attention placebo control in randomized controlled trials of psychosocial interventions: theory and practice. Trials 2015;16:150.
UNHCR. n.d. Convention and Protocol Relating to the Status of Refugees. Available: https://www.unhcr.org/media/convention-andprotocol-relating-status-refugees
Gensichen J, Hiller TS, Breitbart J, et al. Panic Disorder in Primary Care: The Effects of a Team-Based Intervention. Dtsch Ärztebl Int 2019.
Schneider S, Blatter-Meunier J, Herren C, et al. Disorder-specific cognitive-behavioral therapy for separation anxiety disorder in young children: a randomized waiting-list-controlled trial. Psychother Psychosom 2011;80:206-15.
Wennig R. Potential problems with the interpretation of hair analysis results. Forensic Sci Int 2000;107:5-12.
Dettenborn L, Tietze A, Kirschbaum C, et al. The assessment of cortisol in human hair: associations with sociodemographic variables and potential confounders. Stress 2012;15:578-88.
Hollifield M, Toolson EC, Verbillis-Kolp S, et al. Effective Screening for Emotional Distress in Refugees: The Refugee Health Screener. J Nerv Ment Dis 2016;204:247-53.
Margraf J, Schneider S. Lehrbuch Der Verhaltenstherapie. Bd. 1, Grundlagen, Diagnostik, Verfahren, Rahmenbedingungen. 3., Vollständig Bearbeitete Und Erw. Aufl. Springer Medizin: Heidelberg, 2009.
Margraf J, Schneider S. Lehrbuch Der Verhaltenstherapie. Band 2, Störungen Im Erwachsenenalter - Spezielle Indikationen - Glossar. 3., Vollständig Bearbeitete Und Erw. Aufl. Heidelberg: Springer Medizin, 2009.
Gensichen J, Hiller TS, Breitbart J, et al. Evaluation of a practice team-supported exposure training for patients with panic disorder with or without agoraphobia in primary care - study protocol of a cluster randomised controlled superiority trial. Trials 2014;15:112.
Cuijpers P, Donker T, van Straten A, et al. Is guided self-help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies. Psychol Med 2010;40:1943-57.
Lewis C, Pearce J. Efficacy, cost-effectiveness and acceptability of self-help interventions for anxiety disorders: systematic review. Br J Psychiatry 2012;200:15-21.
Seekles W, Cuijpers P, Kok R, et al. Psychological treatment of anxiety in primary care: a meta-analysis. Psychol Med 2013;43:351-61.
Hof E van, Cuijpers P, Stein DJ. Self-Help and Internet-Guided Interventions in Depression and Anxiety Disorders: A Systematic Review of Meta-Analyses. CNS Spectr 2009;14:34-40.
Rathod S, Kingdon DG, Pinninti N, et al. Cultural adaptation of CBT for serious mental illness: a guide for training and practice. Chichester, West Sussex Malden, MA: Wiley Blackwell, 2015.
The Royal College of Psychiatrists. Antisocial behaviour and conduct disorders in children and young people: recognition, intervention and management. Leicester, London: The British Psychological Society, 2013.
World Health Organization. WHO guidelines on parenting interventions to prevent maltreatment and enhance parent-child relationships with children aged 0-17 years. Geneva, Switzerland, 2022.
Speetjens P, Smit F, et al. Effectiveness of the Triple P Positive Parenting Program on Parenting: A Meta‐Analysis. Fam Relat 2008;57:553-66.
Thomas R, Zimmer-Gembeck MJ. Behavioral outcomes of Parent-Child Interaction Therapy and Triple P-Positive Parenting Program: a review and meta-analysis. J Abnorm Child Psychol 2007;35:475-95.
Phelan RF, Howe DJ, Cashman EL, et al. Enhancing parenting skills for parents with mental illness: the Mental Health Positive Parenting Program. Med J Aust 2013;199:S30-3.
Morawska A, Sanders M, Goadby E, et al. Is the Triple P-Positive Parenting Program Acceptable to Parents from Culturally Diverse Backgrounds? J Child Fam Stud 2011;20:614-22.
Klein J, von dem Knesebeck O. Inequalities in health care utilization among migrants and non-migrants in Germany: a systematic review. Int J Equity Health 2018;17:160.
Khatib HE, Alyafei A, Shaikh M. Understanding experiences of mental health help-seeking in Arab populations around the world: a systematic review and narrative synthesis. BMC Psychiatry 2023;23:324.
Barghadouch A, Kristiansen M, Jervelund SS, et al. Refugee children have fewer contacts to psychiatric healthcare services: an analysis of a subset of refugee children compared to Danish-born peers. Soc Psychiatry Psychiatr Epidemiol 2016;51:1125-36.
Bonnin G, Kröber S, Schneider S, et al. Blended learning for diagnostic skills: a multicenter cluster randomized non-inferiority trial. 2023.
Bieda A, Hirschfeld G, Schönfeld P, et al. Universal happiness? Cross-cultural measurement invariance of scales assessing positive mental health. Psychol Assess 2017;29:408-21.
Scholten S, Velten J, Bieda A, et al. Testing measurement invariance of the Depression, Anxiety, and Stress Scales (DASS-21) across four countries. Psychol Assess 2017;29:1376-90.
Mehl MR, Conner TS, Csikszentmihalyi M. Handbook of research methods for studying daily life. Paperback Edition (Psychology). New York London: The Guilford Press, 2014.
Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol 2008;4:1-32.
Badahdah A. Parenting Young Arab Children: Psychometric Properties of an Adapted Arabic Brief Version of the Alabama Parenting Questionnaire. Child Psychiatry Hum Dev 2016;47:486-93.
Lave JR, Frank RG, Schulberg HC, et al. Cost-effectiveness of treatments for major depression in primary care practice. Arch Gen Psychiatry 1998;55:645-51.
Hoch JS, Briggs AH, Willan AR. Something old, something new, something borrowed, something blue: a framework for the marriage of health econometrics and cost-effectiveness analysis. Health Econ 2002;11:415-30.
Dehl T, Sauerbrey U, Dreier-Wolfgramm A, et al. Intersectoral care management for older people with cognitive impairment during and after hospital stays [intersec-CM]: study protocol for a process evaluation within a randomised controlled trial. Trials 2021;22:72.
Betancourt TS, Khan KT. The mental health of children affected by armed conflict: protective processes and pathways to resilience. Int Rev Psychiatry 2008;20:317-28.
Heckman JJ. Skill formation and the economics of investing in disadvantaged children. Science 2006;312:1900-2.
Campbell F, Conti G, Heckman JJ, et al. Early childhood investments substantially boost adult health. Science 2014;343:1478-85.
Margraf J, Cwik JC, Pflug V, et al. Strukturierte klinische Interviews zur Erfassung psychischer Störungen über die Lebensspanne: Gütekriterien und Weiterentwicklungen der DIPS-Verfahren. Z Für Klin Psychol Psychother 2017;46:176-86.
Capra C, Kavanagh DJ, Hides L, et al. Brief screening for psychosis-like experiences. Schizophr Res 2013;149:104-7.
Bukenaite A, Stochl J, Mossaheb N, et al. Usefulness of the CAPE-P15 for detecting people at ultra-high risk for psychosis: Psychometric properties and cut-off values. Schizophr Res 2017;189:69-74.
