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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03822598
Other study ID # 16/54571
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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