Feasibility of a randomised trial of Teaching Recovery Techniques (TRT) with refugee youth: results from a pilot of the Swedish UnaccomPanied yOuth Refugee Trial (SUPpORT)

Abstract

Background: Although post-traumatic stress is prevalent among unaccompanied refugee minors (URM), there are few evidence-based psychological interventions for this group. Teaching Recovery Techniques (TRT) is a brief, manualised intervention for trauma-exposed youth, which has shown promising results in exploratory studies. The aim of the present study was to assess the feasibility of conducting a randomised controlled trial (RCT) evaluating the use of TRT among URM by investigating key uncertainties relating to recruitment, randomisation, intervention delivery and data collection.

Methods: A 3-month long non-blinded internal randomised pilot trial with a parallel-group design assessed the feasibility of a planned nationwide multi-site RCT. URM with or without granted asylum were eligible if they were 14 to 20 years old, had arrived in Sweden within the last 5 years and had screened positive for symptoms of post-traumatic stress disorder (PTSD). Quantitative data were collected pre- and post-intervention, and 18 weeks after randomisation. On-site individual randomisation (1:1) followed directly after pre-intervention assessment. Participants allocated to the intervention were offered seven weekly group-based TRT sessions. Quantitative pilot outcomes were analysed using descriptive statistics. Qualitative information was gathered through on-site observations and follow-up dialogue with group facilitators. A process for Decision-making after Pilot and feasibility Trials (ADePT) was used to support systematic decision-making in moving forward with the trial.

Results: Fifteen URM (mean age 17.73 years) with PTSD symptoms were recruited at two sites. Three of the youths were successfully randomised to either TRT or waitlist control (TRT n = 2, waitlist n = 1). Fourteen participants were offered TRT for ethical reasons, despite not being randomised. Six (43%) attended ≥ 4 of the seven sessions. Seventy-three percent of the participants completed at least two assessments, with a response rate of 53% at both post-intervention and follow-up.

Conclusions: The findings demonstrated a need for amendments to the protocol, especially with regard to the procedures for recruitment and randomisation. Upon refinement of the study protocol and strategies, an adequately powered RCT was pursued, with data from this pilot study excluded.

Trial registration: ISRCTN47820795 , prospectively registered on 20 December 2018.

Keywords: Feasibility; Post-traumatic stress disorder; Randomised pilot trial; Teaching recovery techniques; Unaccompanied asylum-seeking and refugee minors.

Fig. 1

CONSORT flow diagram

Fig. 2

Identified problems and their solutions according to the ADePT framework