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

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, ID: DRKS00017453. Registered December 11th, 2019. URL: https://www.drks.de/drks_web/setLocale_EN.do