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).
Feasibility
Post-traumatic stress disorder
Randomised pilot trial
Teaching recovery techniques
Unaccompanied asylum-seeking and refugee minors
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
14 Feb 2022
14 Feb 2022
Historique:
received:
12
10
2020
accepted:
01
02
2022
entrez:
15
2
2022
pubmed:
16
2
2022
medline:
16
2
2022
Statut:
epublish
Résumé
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.
Sections du résumé
BACKGROUND
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
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
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
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
BACKGROUND
ISRCTN47820795 , prospectively registered on 20 December 2018.
Identifiants
pubmed: 35164865
doi: 10.1186/s40814-022-00998-1
pii: 10.1186/s40814-022-00998-1
pmc: PMC8843024
doi:
Types de publication
Journal Article
Langues
eng
Pagination
40Subventions
Organisme : Kavli Trust (NO)
ID : A-321629
Informations de copyright
© 2022. The Author(s).
Références
Med Care. 2001 Jun;39(6):627-34
pubmed: 11404645
BMC Health Serv Res. 2013 Jun 15;13:217
pubmed: 23768141
J Child Psychol Psychiatry. 2018 Nov;59(11):1171-1179
pubmed: 29624664
Eur Child Adolesc Psychiatry. 2019 Dec;28(12):1671-1682
pubmed: 31004294
Qual Life Res. 2012 Sep;21(7):1249-53
pubmed: 21984467
Child Care Health Dev. 2019 Mar;45(2):198-215
pubmed: 30661259
Eur J Psychotraumatol. 2013;4:
pubmed: 23330058
Int J Environ Res Public Health. 2017 Oct 04;14(10):
pubmed: 28976937
Child Abuse Negl. 1997 Apr;21(4):351-66
pubmed: 9134264
Scand J Psychol. 2016 Dec;57(6):564-570
pubmed: 27535348
Eur Arch Psychiatry Clin Neurosci. 2020 Feb;270(1):95-106
pubmed: 30796528
Trials. 2020 Jan 10;21(1):63
pubmed: 31924247
Trials. 2013 Oct 25;14:353
pubmed: 24160371
Arch Intern Med. 2006 May 22;166(10):1092-7
pubmed: 16717171
Am J Psychiatry. 2011 Dec;168(12):1266-77
pubmed: 22193671
Behav Cogn Psychother. 2015 Sep;43(5):549-61
pubmed: 24709121
Eur Child Adolesc Psychiatry. 2018 Apr;27(4):467-479
pubmed: 29260422
J Trauma Stress. 2017 Oct;30(5):531-536
pubmed: 28992383
Eur Child Adolesc Psychiatry. 2021 Dec;30(12):1995-1996
pubmed: 32661614
J Immigr Minor Health. 2021 Jun;23(3):624-639
pubmed: 33590440
J Nerv Ment Dis. 2007 Apr;195(4):288-97
pubmed: 17435478
Transcult Psychiatry. 2017 Oct-Dec;54(5-6):756-782
pubmed: 29115909
Acta Paediatr. 2021 Feb;110(2):563-570
pubmed: 32762094
Qual Life Res. 2009 Oct;18(8):1105-13
pubmed: 19693703
Eur Child Adolesc Psychiatry. 2014 May;23(5):337-46
pubmed: 23979476
Trials. 2020 Dec 9;21(1):1013
pubmed: 33298126
BMJ. 2016 Oct 24;355:i5239
pubmed: 27777223
Behav Res Ther. 2004 Oct;42(10):1129-48
pubmed: 15350854
BMC Health Serv Res. 2017 Jan 26;17(1):88
pubmed: 28126032
Child Adolesc Psychiatry Ment Health. 2019 Jan 30;13:8
pubmed: 30719070
Child Adolesc Psychiatry Ment Health. 2019 May 17;13:22
pubmed: 31131021
Health Expect. 2021 May;24 Suppl 1:30-39
pubmed: 31705620
Health Policy. 2019 Sep;123(9):851-863
pubmed: 30850148
BMJ. 2003 Dec 13;327(7428):1400-2
pubmed: 14670893
Scand J Psychol. 2015 Apr;56(2):203-11
pubmed: 25614276
Scand J Public Health. 2017 Aug;45(6):605-611
pubmed: 28669316
Child Abuse Negl. 2019 Dec;98:104146
pubmed: 31521903
Int J Environ Res Public Health. 2020 Dec 23;18(1):
pubmed: 33374648
J Gen Intern Med. 2001 Sep;16(9):606-13
pubmed: 11556941