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      Improving mental health care for unaccompanied young refugees through a stepped-care approach versus usual care+: study protocol of a cluster randomized controlled hybrid effectiveness implementation trial

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          Abstract

          Background

          More than half of the unaccompanied young refugees (UYRs) resettled in Europe report elevated levels of posttraumatic stress symptoms (PTSS) and comorbid symptoms. Earlier studies have highlighted the effectiveness of the trauma-focused preventive group intervention “Mein Weg” (English “My Way”), and the feasibility of trauma-focused cognitive behavioral therapy (TF-CBT) for UYRs. Both interventions are deemed to be empirically supported treatments (ESTs). However, UYRs seldom receive ESTs or, in fact, any treatment at all. In view of the high need and the limited treatment resources available, a stepped-care approach is indicated but has not been evaluated so far. The purpose of this trial is to compare the stepped-care approach BETTER CARE with usual care enhanced with screening and indication (usual care+).

          Methods

          In a cluster randomized controlled trial involving N = 540 UYRs living in up to N = 54 child and youth welfare service (CYWS) facilities, BETTER CARE will be compared with usual care+. We will randomize clusters comprising a CYWS facility with at least one eligible psychotherapist. BETTER CARE consists of step (1) screening and indication and either step (2) preventive trauma-focused group intervention “Mein Weg” delivered by trained CYWS staff or step (3) TF-CBT delivered by trained community therapists and supported by trained translators if necessary. Participants will be assessed 6 and 12 months after randomization. The primary outcome is the severity of PTSS after 12 months. Secondary outcomes are depressive and anxiety symptoms, quality of life, and proxy reported PTSS. Furthermore, drug use, health costs, benefits, and long-term effects on integration/acculturation will be assessed.

          Discussion

          The trial will directly integrate a stepped-care approach into existing structures of the German child welfare and (mental) health system. It could, therefore, serve as a blueprint for how to implement ESTs for UYRs. If successful, screening, prevention, and intervention will be sustainably implemented in CYWS in southern Germany.

          Trial registration

          German Clinical Trials Register DRKS00017453. Registered on 11 December 2019.

          Supplementary information

          The online version contains supplementary material available at 10.1186/s13063-020-04922-x.

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          Most cited references49

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          A brief measure for assessing generalized anxiety disorder: the GAD-7.

          Robert L Spitzer, Kurt Kroenke, Janet B W Williams … (2006)
          Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity. A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use. A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
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            The PHQ-9: validity of a brief depression severity measure.

            K Kroenke, R L Spitzer, J B Williams (2001)
            While considerable attention has focused on improving the detection of depression, assessment of severity is also important in guiding treatment decisions. Therefore, we examined the validity of a brief, new measure of depression severity. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ-9 was completed by 6,000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-9 depression severity increased, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and health care utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-9 score > or =10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Results were similar in the primary care and obstetrics-gynecology samples. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool.
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              The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review.

              Kurt Kroenke, Robert L Spitzer, Janet B W Williams … (2010)
              Depression, anxiety and somatization are the most common mental disorders in primary care as well as medical specialty populations; each is present in at least 5-10% of patients and frequently comorbid with one another. An efficient means for measuring and monitoring all three conditions would be desirable. Evidence regarding the psychometric and pragmatic characteristics of the Patient Health Questionnaire (PHQ)-9 depression, generalized anxiety disorder (GAD)-7 anxiety and PHQ-15 somatic symptom scales are synthesized from two sources: (1) four multisite cross-sectional studies (three conducted in primary care and one in obstetric-gynecology practices) comprising 9740 patients, and (2) key studies from the literature that have studied these scales. The PHQ-9 and its abbreviated eight-item (PHQ-8) and two-item (PHQ-2) versions have good sensitivity and specificity for detecting depressive disorders. Likewise, the GAD-7 and its abbreviated two-item (GAD-2) version have good operating characteristics for detecting generalized anxiety, panic, social anxiety and post-traumatic stress disorder. The optimal cutpoint is > or = 10 on the parent scales (PHQ-9 and GAD-7) and > or = 3 on the ultra-brief versions (PHQ-2 and GAD-2). The PHQ-15 is equal or superior to other brief measures for assessing somatic symptoms and screening for somatoform disorders. Cutpoints of 5, 10 and 15 represent mild, moderate and severe symptom levels on all three scales. Sensitivity to change is well-established for the PHQ-9 and emerging albeit not yet definitive for the GAD-7 and PHQ-15. The PHQ-9, GAD-7 and PHQ-15 are brief well-validated measures for detecting and monitoring depression, anxiety and somatization. Copyright 2010. Published by Elsevier Inc.
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                Author and article information

                Contributors
                Rita Rosner: Rita.Rosner@ku.de
                Cedric Sachser: cedric.sachser@uniklinik-ulm.de
                Fabienne Hornfeck: hornfeck@dji.de
                Reinhold Kilian: reinhold.kilian@uni-ulm.de
                Heinz Kindler: kindler@dji.de
                Rainer Muche: rainer.muche@uni-ulm.de
                Lauritz Rudolf Floribert Müller: lauritz.mueller@ku.de
                Jonathan Thielemann: Jonathan.Thielemann@ku.de
                Tamara Waldmann: tamara.waldmann@uni-ulm.de
                Ute Ziegenhain: ute.ziegenhain@uniklinik-ulm.de
                Johanna Unterhitzenberger: Johanna.Unterhitzenberger@ku.de
                Elisa Pfeiffer:
                ORCID: http://orcid.org/0000-0002-9742-3004
                elisa.pfeiffer@uniklinik-ulm.de
                Journal
                Journal ID (nlm-ta): Trials
                Journal ID (iso-abbrev): Trials
                Title: Trials
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1745-6215
                Publication date (Electronic): 9 December 2020
                Publication date PMC-release: 9 December 2020
                Publication date Collection: 2020
                Volume: 21
                Electronic Location Identifier: 1013
                Affiliations
                [1 ]GRID grid.440923.8, ISNI 0000 0001 1245 5350, Department of Psychology, , Catholic University Eichstätt-Ingolstadt, ; Ostenstr. 26, 85071 Eichstätt, Germany
                [2 ]GRID grid.6582.9, ISNI 0000 0004 1936 9748, Clinic for Child and Adolescent Psychiatry/Psychotherapy, , Ulm University, ; Steinhövelstr. 1, 89075 Ulm, Germany
                [3 ]GRID grid.424214.5, ISNI 0000 0001 1302 5619, German Youth Institute, ; Nockherstr. 2, 81541 Munich, Germany
                [4 ]GRID grid.6582.9, ISNI 0000 0004 1936 9748, Clinic for Psychiatry and Psychotherapy II, , Ulm University, ; Ludwig-Heilmeyer-Str., 89312 Günzburg, Germany
                [5 ]GRID grid.6582.9, ISNI 0000 0004 1936 9748, Institute of Epidemiology and Medical Biometry, , Ulm University, ; Schwabstr. 13, 89075 Ulm, Germany
                Author information
                http://orcid.org/0000-0002-9742-3004
                Article
                Publisher ID: 4922
                DOI: 10.1186/s13063-020-04922-x
                PMC ID: 7724616
                PubMed ID: 33298126
                SO-VID: 8e9fd9f8-378b-434c-86e0-4b7e51cca6bf
                Copyright © © The Author(s) 2020
                License:

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                Date received : 5 August 2020
                Date accepted : 19 November 2020
                Funding
                Funded by: German Ministry of Education and Research
                Award ID: 01EF1802A
                Award ID: 01EF1802B
                Award ID: 01EF1802C
                Award Recipient :
                Categories
                Subject: Study Protocol
                Custom metadata
                issue-copyright-statement © The Author(s) 2020

                ScienceOpen disciplines: Medicine
                Keywords: stepped care,cluster randomized trial,dissemination,refugee minors,posttraumatic stress,interpreters,trauma-informed care,healthcare costs
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: stepped care, cluster randomized trial, dissemination, refugee minors, posttraumatic stress, interpreters, trauma-informed care, healthcare costs

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