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

January 28, 2019 updated by: Brit Oppedal, Norwegian Institute of Public Health

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

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

Interventional

Enrollment (Actual)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

-

Exclusion Criteria:

  • Psychosis,
  • Mental disabilities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
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.
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 20, 2017

Primary Completion (ACTUAL)

May 31, 2018

Study Completion (ACTUAL)

June 30, 2018

Study Registration Dates

First Submitted

January 21, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (ACTUAL)

January 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is not yet known if there will be a plan to make Individual Patient Data (IPD) available. If IPD are to be shared, we follow the regulations of the Norwegian Institute of Public Health

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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