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Completed

NCT Number: NCT03822598

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

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.

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Key information

Age range

8 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bergen Municipality, Bergen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teaching Recovery Techniques, TRT

Behavioral

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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).

Sponsors and collaborators

Lead sponsor

Norwegian Institute of Public Health

Other Gov

Collaborators

  • Norwegian Directorate of Immigration
  • Norwegian Directorate of Integration and Diversity
  • The Norwegian Directorate for Children, Youth and Family Affairs
  • University of Bergen
  • University of Tromso

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2019
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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