- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03822598
Promoting Asylum-seeking and Refugee Children's Coping With Trauma
Implementation and Evaluation of Teaching Recovery Techniques (TRT) Among Asylum-seeking and Refugee Children
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Bergen, Norway
- Bergen Municipality
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Dokka, Norway
- Nordre Land municipality
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Drammen, Norway
- Drammen Municipality
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Drevsjø, Norway
- Engerdal Municipality
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Fredrikstad, Norway
- Fredrikstad municipality
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Gjøvik, Norway
- Gjøvik municipality
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Hønefoss, Norway
- Ringerike Municipality
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Kirkenær, Norway
- Grue municipality
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Leira, Norway
- Levanger municipality
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Lyng, Norway
- Lyngdal municipality
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Lyngdal, Norway
- Lyngdal municipality
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Rud, Norway
- Bærum municipality
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Sjøvegan, Norway
- Salten municipality
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Stavanger, Norway
- Stavanger municipality
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Trondheim, Norway
- Trondheim Municipality
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Vadsø, Norway
- Vadsø municipality
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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Exclusion Criteria:
- Psychosis,
- Mental disabilities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Intervention group
Teaching Recovery Techniques implemented 1- 3 weeks after recruitment
|
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)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's Revised Impact of Event Scale (CRIES-13)
Time Frame: 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)
|
Change in CRIES-13 scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Screen for Child Anxiety Related Disorders (SCARED). 9 items tapping symptoms of generalized anxiety disorder, and 7 items tapping symptoms of social anxiety
Time Frame: 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)
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Change in SCARED-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
|
|
Cantril Ladder
Time Frame: 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)
|
Change in scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
|
|
Montgomery-Aasberg Depression Scale, MADRS
Time Frame: Change in MADRS-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
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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.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/54571
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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