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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03822598
• Other study ID #: 16/54571
• Status: Completed
• Phase: N/A
• Start date: June 20, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2019
• Source: Norwegian Institute of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: June 30, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Disease
• Mental Disorders
• Mental Health Disorder
• Post-Traumatic Stress Disorder in Adolescence
• Social Anxiety
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
Norway	Bergen Municipality	Bergen
Norway	Nordre Land municipality	Dokka
Norway	Drammen Municipality	Drammen
Norway	Engerdal Municipality	Drevsjø
Norway	Fredrikstad municipality	Fredrikstad
Norway	Gjøvik municipality	Gjøvik
Norway	Ringerike Municipality	Hønefoss
Norway	Grue municipality	Kirkenær
Norway	Levanger municipality	Leira
Norway	Lyngdal municipality	Lyng
Norway	Lyngdal municipality	Lyngdal
Norway	Bærum municipality	Rud
Norway	Salten municipality	Sjøvegan
Norway	Stavanger municipality	Stavanger
Norway	Trondheim municipality	Trondheim
Norway	Vadsø municipality	Vadsø

Sponsors (6)

Lead Sponsor	Collaborator
Norwegian Institute of Public Health	Norwegian Directorate of Children, Youth, and Family Affairs, Norwegian Directorate of Immigration, Norwegian Directorate of Integration and Diversity, University of Bergen, University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Revised Impact of Event Scale (CRIES-13)	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)	Change in CRIES-13 scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
Secondary	Screen for Child Anxiety Related Disorders (SCARED). 9 items tapping symptoms of generalized anxiety disorder, and 7 items tapping symptoms of social anxiety	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)	Change in SCARED-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
Secondary	Cantril Ladder	Measures current subjective well-being on a ladder With 11 steps from "worst possible life" (0) to "best possible life" (10)	Change in scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
Secondary	Montgomery-Aasberg Depression Scale, MADRS	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).	Change in MADRS-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.