Condition category
Mental and Behavioural Disorders
Date applied
13/12/2018
Date assigned
20/12/2018
Last edited
20/12/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
In 2015, 162,877 people sought asylum in Sweden, 42% of whom were children and youth. Refugee children, especially unaccompanied refugee minors, have often experienced traumas and are at significant risk of developing mental health problems, such as symptoms of post-traumatic stress disorder (PTSD) and depression, that can continue years after resettlement. This study aims to evaluate a community-based intervention for refugee youth experiencing post-traumatic stress symptoms called ‘Teaching Recovery Techniques’.

Who can participate?
Unaccompanied refugee youths (aged 14 - 20) who score high on a post-traumatic stress survey and have spent less than 5 years in Sweden

What does the study involve?
Youths referred for ‘Teaching Recovery Techniques’ who meet the study criteria are randomly allocated to a group that receives the intervention straight away or a group that receives the intervention a little later. Changes in youth mental health and wellbeing are measured using surveys at 8 weeks and 20 weeks after the group allocation.

What are the possible benefits and risks of participating?
The potential benefit to participating youths is improved mental health and wellbeing. A safety protocol to prevent self-harm among participants has been developed. In case of a positive answer on wishing one were dead on a depression survey, an individual assessment is performed using the Columbia Suicide Severity Rating Scale, screener version. The guidelines include clear instructions on who to call and what to do depending on the score. The safety protocol is revised for each site and signed by local senior managers.

Where is the study run from?
The Child Health and Parenting (CHAP) research group at Uppsala University (Sweden)

When is the study starting and how long is it expected to run for?
April 2018 to September 2020

Who is funding the study?
The Kavli Trust

Who is the main contact?
Prof. Anna Sarkadi
anna.sarkadi@pubcare.uu.se

Trial website

www.pubcare.uu.se/forskning/chap/projekt/aktuella-projekt/swedish-unaccompanied-youth-refugee-trial--support-/

Contact information

Type

Scientific

Primary contact

Prof Anna Sarkadi

ORCID ID

Contact details

BMC
Husargatan 3
Uppsala
751 22
Sweden
+46 (0)18 471 6572
anna.sarkadi@pubcare.uu.se

Type

Public

Additional contact

Ms Elin Lampa

ORCID ID

Contact details

BMC
Husargatan 3
Uppsala
751 22
Sweden
+46 (0)18 471 6574
elin.lampa@pubcare.uu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluation of the Teaching Recovery Techniques community-based intervention for unaccompanied refugee youth experiencing post-traumatic stress symptoms – a randomised controlled study

Acronym

Swedish UnaccomPanied yOuth Refugee Trial (SUPpORT)

Study hypothesis

It is hypothesised that, when compared with youths who have not received the intervention (the waitlist control arm), youths who have received Teaching Recovery Techniques (the intervention arm) will demonstrate fewer self-reported symptoms of mental ill-health, specifically post-traumatic stress, depression and anxiety symptoms.

It is further hypothesised that, when compared with the control arm, the intervention arm will report greater self-efficacy and wellbeing.

Ethics approval

Regional Ethical Review Board in Uppsala, 28/11/2018, ref: 2018/382

Study design

Two-arm randomised waitlist control superiority trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format at time of registration, please use contact details to request a participant information sheet.

Condition

Post-traumatic stress disorder (symptoms)

Intervention

Block randomisation of block sizes 4, 6, or 8 will be generated in a computerized randomisation schedule (with 1:1 allocation ratio).

The intervention arm will receive the Swedish translation of the Teaching Recovery Techniques (TRT) programme. This group-based cognitive-behavioural programme includes 2 caregiver sessions and 5 youth sessions. Youth sessions focus on psychoeducation, intrusion, arousal and avoidance. Caregiver sessions focus on psychoeducation and are delivered in parallel with the first 2 youth sessions. A ‘getting to know each other session’ will be offered prior to the core TRT sessions and a ‘follow-up session’, which consolidates learning and enables participants to talk about their experience of taking part in the programme, will be offered afterwards. Sessions will be delivered over 7 consecutive weeks. Each session will last 2 hours (including a break). TRT facilitators will receive 3 days of training in programme delivery.

The waitlist control arm will receive services as usual, meaning services to which they are entitled and could potentially receive in the absence of the trial. Once the 20-week follow up data has been collected for the intervention arm, the waitlist control arm will be offered TRT.

Concomitant care: Parallel individual intervention/therapy for PTSD or psychosocial support is allowed, but the therapist must be informed and recommend participation. A parallel, different, group intervention is not recommended.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Measured at baseline, 8 and 20 weeks:
1. Post-traumatic stress symptoms, measured using the Children’s Revised Impact of Event Scale (CRIES-8; Perrin, Meiser-Stedman et al. 2005)
2. Depression symptoms, measured using the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)
3. Anxiety symptoms, measured using the Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)

Secondary outcome measures

Measured at baseline, 8 and 20 weeks:
1. Self-efficacy, measured using the General Self Efficacy Scale (GSE; Schwarzer & Jerusalem, 1995)
2. Wellbeing, measured using the Cantril Ladder (Cantril, 1966; picture from från Sawatzky et al., 1966; modified for use in the present study)

Overall trial start date

01/04/2018

Overall trial end date

30/09/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Participants eligible for the trial must comply with all of the following at randomization:
1. Youth age ≥14 years
2. Time spent in Sweden < 5 years
3. Arrived in Sweden unaccompanied
4. Screening positive on the CRIES-8 PTSD screening tool (≥17 points)
5. Interest to participate in a group intervention & consent to be randomized
6. Legal guardian consenting to participation if child is <15 years

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

218 youths to be randomised (1:1 allocation)

Participant exclusion criteria

1. Youth age >20
2. Time spent in Sweden > 5 years
3. Current treatment where therapist advises against intervention
4. Not screening positive on the CRIES-8 PTSD screening tool (≤16 points)
5. No interest to participate in a group intervention
6. Legal guardian not consenting to participation if child is <15 years

Recruitment start date

01/01/2019

Recruitment end date

28/02/2020

Locations

Countries of recruitment

Sweden

Trial participating centre

Child Health and Parenting (CHAP)
BMC, Husargatan 3
Uppsala
751 22
Sweden

Sponsor information

Organisation

Uppsala University

Sponsor details

Box 256
Uppsala
751 05
Sweden
+46 (0)18 471 00 00
contact@uu.se

Sponsor type

University/education

Website

www.uu.se

Funders

Funder type

Charity

Funder name

The Kavli Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Trial protocol and results to be published.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Anna Sarkadi (anna.sarkadi@pubcare.uu.se).

Intention to publish date

31/03/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes