Rondung Elisabet, Leiler Anna, Sarkadi Anna, Bjärtå Anna, Lampa Elin, Löfving Sandra Gupta, Calam Rachel, Oppedal Brit, Keeshin Brooks, Warner Georgina
Department of Psychology and Social Work, Mid Sweden University, 831 25, Östersund, Sweden.
Child Health and Parenting (CHAP), Department of Public Health and Caring Sciences, Uppsala University, Box 564, BMC, Husargatan 3, 751 22, Uppsala, Sweden.
Pilot Feasibility Stud. 2022 Feb 14;8(1):40. doi: 10.1186/s40814-022-00998-1.
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.
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.
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.
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.
ISRCTN47820795 , prospectively registered on 20 December 2018.
尽管创伤后应激在无人陪伴的难民未成年人(URM)中很普遍,但针对这一群体的循证心理干预措施却很少。创伤恢复技术教学(TRT)是一种针对受创伤青少年的简短、手册化干预措施,在探索性研究中已显示出有前景的结果。本研究的目的是通过调查与招募、随机分组、干预实施和数据收集相关的关键不确定因素,评估开展一项随机对照试验(RCT)以评估URM中TRT使用情况的可行性。
一项为期3个月的非盲内部随机试点试验采用平行组设计,评估了一项计划中的全国多中心RCT的可行性。14至20岁、在过去5年内抵达瑞典且创伤后应激障碍(PTSD)症状筛查呈阳性的有或无庇护资格的URM符合条件。在干预前、干预后以及随机分组后18周收集定量数据。干预前评估后直接进行现场个体随机分组(1:1)。分配到干预组的参与者接受为期七周的基于小组的TRT课程。使用描述性统计分析定量试点结果。通过现场观察和与小组 facilitator 的后续对话收集定性信息。采用试点和可行性试验后的决策流程(ADePT)来支持推进试验的系统决策。
在两个地点招募了15名有PTSD症状的URM(平均年龄17.73岁)。其中三名青少年成功随机分组到TRT组或等待名单对照组(TRT组n = 2,等待名单组n = 1)。出于伦理原因,14名参与者虽未被随机分组但接受了TRT。六名(43%)参与者参加了七次课程中的至少四次。73%的参与者完成了至少两次评估,干预后和随访时的应答率均为53%。
研究结果表明需要对方案进行修订,特别是在招募和随机分组程序方面。在完善研究方案和策略后,开展了一项有足够效力的RCT,本试点研究的数据被排除在外。
ISRCTN47820795,于2018年12月20日前瞻性注册。