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Published in: Trials 1/2020

01-12-2020 | Care | Study protocol

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

Authors: Rita Rosner, Cedric Sachser, Fabienne Hornfeck, Reinhold Kilian, Heinz Kindler, Rainer Muche, Lauritz Rudolf Floribert Müller, Jonathan Thielemann, Tamara Waldmann, Ute Ziegenhain, Johanna Unterhitzenberger, Elisa Pfeiffer

Published in: Trials | Issue 1/2020

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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.
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Rita Rosner
Cedric Sachser
Fabienne Hornfeck
Reinhold Kilian
Heinz Kindler
Rainer Muche
Lauritz Rudolf Floribert Müller
Jonathan Thielemann
Tamara Waldmann
Ute Ziegenhain
Johanna Unterhitzenberger
Elisa Pfeiffer
Publication date
01-12-2020
Publisher
BioMed Central
Keyword
Care
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04922-x

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