Accompanied refugeeS In Sweden Trial (ASsIST)

Not Applicable

Completed

• Conditions: Post-traumatic stress; Mental and Behavioural Disorders; Post-traumatic stress disorder

• Registration Number: ISRCTN17754931
• Lead Sponsor: ppsala University

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32713847/ protocol (added 28/07/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-04
• Study Completion: 2021-09-30
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Participants eligible for the trial must comply with all of the following at randomization:
1. Child age =8 years
2. Time spent in Sweden 5 years or less
3. Arrived in Sweden accompanied
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 aged <15 years

Exclusion Criteria

1. Youth age >17
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 aged <15 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Parent- and self-reported child mental health, specifically post-traumatic stress, depression and anxiety symptoms, at pre-intervention (T1), c.8 weeks after randomisation (T2) and c.20 weeks after randomisation (T3):<br>1. Post-traumatic stress symptoms measured using Children’s Impact of Events Scale (CRIES-13; Perrin, Meiser-Stedman, & Smith, 2005)<br>2. Depression symptoms measured using Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)<br>3. Anxiety symptoms measured using The Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)

Secondary Outcome Measures

Name	Time	Method
Measured at pre-intervention (T1), c.8 weeks after randomisation (T2) and c.20 weeks after randomisation (T3):<br>1. Emotional and behavioural difficulties measured using Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)<br>2. Self-efficacy measured using General Self Efficacy Scale (GSE; Schwarzer & Jerusalem, 1995)<br>3. Wellbeing measured using The Cantril Ladder (Cantril, 1966; picture from Sawatzky et al.,1966; modified for use in the present study)