Promoting Asylum-seeking and Refugee Children's Coping With Trauma

Sponsor

Norwegian Institute of Public Health (Other)

Overall Status

Completed

CT.gov ID

NCT03822598

Collaborator

University of Tromso (Other), University of Bergen (Other), Norwegian Directorate of Children, Youth, and Family Affairs (Other), Norwegian Directorate of Immigration (Other), Norwegian Directorate of Integration and Diversity (Other)

170

Enrollment

Locations

Arms

12.3

Actual Duration (Months)

10.6

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A short term trauma-focused cognitive- behavioral program to reduce trauma-related mental health problems among asylum-seeking and refugee children.

The main hypothesis of the study is that the TRT program significantly improves mental health (i.e. reduces symptoms of post-traumatic symptoms, depression and generalized anxiety and increases perceived quality of life (Qol) in the intervention group compared to the waiting-list control group.

Condition or Disease	Intervention/Treatment	Phase
Mental Health Disorder Post-Traumatic Stress Disorder in Adolescence Depression Social Anxiety	Behavioral: Teaching Recovery Techniques, TRT	N/A

Detailed Description

Teaching Recovery Techniques (TRT) was developed by Children and War Foundation (www.childrenandwarfoundation.org ) as a tool to support children in coping with their mental reactions to being exposed to war and catastrophes. TRT has proven to be effective in reducing trauma-related mental health symptoms in such contexts. However, it has never been used with children experiencing all the uncertainties and stress of an asylum-seeking context, or with refugee children in high-income countries. The main aim of the present study is therefore to implement and evaluate the TRT among asylum-seeking and refugee children in the context of four different care conditions: 1)asylum-seeking children who arrived accompanied by a legal care-taker 2) asylum-seeking children less than 15 years in care centers administered by the Child Welfare Services 3) asylum-seeking children 15 years and older living in asylum centers regulated by the Directorate of Immigration 4) Former unaccompanied asylum-seeking children who have been granted residence (refugees) and are resettled in a municipality in Norway.

Based on Power analyses, the target group is 40 children in each care condition (total n = 160) > 9 years speaking Arabic, Tigrinya, Somali, Dari, or Pashto.

The study employs a randomized clustered experimental design that includes a waiting list control group, which will receive the TRT when the intervention group has completed the program.

Study Design

Study Type:

Interventional

Actual Enrollment :

170 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Two stages of recruitment: 1) We recruited asylum reception centers and refugee resettlement municipalities located all over Norway 2) Invite asylum-seeking and refugee children in these institutions to participate, and assigning them by intstitution to control and intervention conditions. The intervention groups started implementing TRT between late September and late October. The control groups started implementing TRT between medio November and beginning of February.Two stages of recruitment: 1) We recruited asylum reception centers and refugee resettlement municipalities located all over Norway 2) Invite asylum-seeking and refugee children in these institutions to participate, and assigning them by intstitution to control and intervention conditions. The intervention groups started implementing TRT between late September and late October. The control groups started implementing TRT between medio November and beginning of February.

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Implementation and Evaluation of Teaching Recovery Techniques (TRT) Among Asylum-seeking and Refugee Children

Actual Study Start Date :

Jun 20, 2017

Actual Primary Completion Date :

May 31, 2018

Actual Study Completion Date :

Jun 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Teaching Recovery Techniques implemented 1- 3 weeks after recruitment	Behavioral: Teaching Recovery Techniques, TRT TRT is a , low-threshold, group based, manual driven short term intervention to reduce trauma-related mental health problems. The program is based on principles from trauma-focused cognitive-behavioral therapy
Active Comparator: Wait-list control group Delayed implementation of Teaching Recovery Techniques (after the experimental group has completed the program)	Behavioral: Teaching Recovery Techniques, TRT TRT is a , low-threshold, group based, manual driven short term intervention to reduce trauma-related mental health problems. The program is based on principles from trauma-focused cognitive-behavioral therapy

Arm

Intervention/Treatment

Experimental: Intervention group

Teaching Recovery Techniques implemented 1- 3 weeks after recruitment

Behavioral: Teaching Recovery Techniques, TRT

TRT is a , low-threshold, group based, manual driven short term intervention to reduce trauma-related mental health problems. The program is based on principles from trauma-focused cognitive-behavioral therapy

Active Comparator: Wait-list control group

Delayed implementation of Teaching Recovery Techniques (after the experimental group has completed the program)

Behavioral: Teaching Recovery Techniques, TRT

Outcome Measures

Primary Outcome Measures

Children's Revised Impact of Event Scale (CRIES-13) [Change in CRIES-13 scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.]
Self-reported symptoms of intrusion, hyperarousal and avoidance. ' The participants check how often during the last week they had each symptom from "never" (0); "rarely" (1) "sometimes" (3) and "frequently" (5)

Secondary Outcome Measures

Screen for Child Anxiety Related Disorders (SCARED). 9 items tapping symptoms of generalized anxiety disorder, and 7 items tapping symptoms of social anxiety [Change in SCARED-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.]
Measures if children have perceived each anxiety symptom over the last three months from "not true, or hardly ever true" (0), "somewhat true or sometimes true" (1) "very true or often true" (2)
Cantril Ladder [Change in scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.]
Measures current subjective well-being on a ladder With 11 steps from "worst possible life" (0) to "best possible life" (10)
Montgomery-Aasberg Depression Scale, MADRS [Change in MADRS-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.]
9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life over the last three days. Each item is scored between 0 (not a problem for me) and 3 (affects me very much), with three intermediate levels (0.5, 1.5, 2.5).

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Accompanied asylum-seeking children living in reception centers,
Unaccompanied asylum-seeking children living in reception centers
Unaccompanied refugee minors who have been granted residence

Children in the target Groups reported symptoms of post-traumatic stress above clinical cut-off on Children's Revised Impact of Event Scale, 8 items

Exclusion Criteria:

Psychosis,
Mental disabilities

Contacts and Locations

Locations

	Site	City	Country
1	Bergen Municipality	Bergen	Norway
2	Nordre Land municipality	Dokka	Norway
3	Drammen Municipality	Drammen	Norway
4	Engerdal Municipality	Drevsjø	Norway
5	Fredrikstad municipality	Fredrikstad	Norway
6	Gjøvik municipality	Gjøvik	Norway
7	Ringerike Municipality	Hønefoss	Norway
8	Grue municipality	Kirkenær	Norway
9	Levanger municipality	Leira	Norway
10	Lyngdal municipality	Lyngdal	Norway
11	Lyngdal municipality	Lyng	Norway
12	Bærum municipality	Rud	Norway
13	Salten municipality	Sjøvegan	Norway
14	Stavanger municipality	Stavanger	Norway
15	Trondheim municipality	Trondheim	Norway
16	Vadsø municipality	Vadsø	Norway