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

NCT ID: NCT03822598

Last Updated: 2019-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-20

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mental Health Disorder Post-Traumatic Stress Disorder in Adolescence Depression Social Anxiety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Two stages of recruitment: 1) We recruited asylum reception centers and refugee resettlement municipalities located all over Norway 2) Invite asylum-seeking and refugee children in these institutions to participate, and assigning them by intstitution to control and intervention conditions. The intervention groups started implementing TRT between late September and late October. The control groups started implementing TRT between medio November and beginning of February.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention group

Teaching Recovery Techniques implemented 1- 3 weeks after recruitment

Group Type EXPERIMENTAL

Teaching Recovery Techniques, TRT

Intervention Type 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

Wait-list control group

Delayed implementation of Teaching Recovery Techniques (after the experimental group has completed the program)

Group Type ACTIVE_COMPARATOR

Teaching Recovery Techniques, TRT

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tromso

OTHER

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role collaborator

Norwegian Directorate of Children, Youth, and Family Affairs

UNKNOWN

Sponsor Role collaborator

Norwegian Directorate of Immigration

UNKNOWN

Sponsor Role collaborator

Norwegian Directorate of Integration and Diversity

UNKNOWN

Sponsor Role collaborator

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Brit Oppedal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bergen Municipality

Bergen, , Norway

Site Status

Nordre Land municipality

Dokka, , Norway

Site Status

Drammen Municipality

Drammen, , Norway

Site Status

Engerdal Municipality

Drevsjø, , Norway

Site Status

Fredrikstad municipality

Fredrikstad, , Norway

Site Status

Gjøvik municipality

Gjøvik, , Norway

Site Status

Ringerike Municipality

Hønefoss, , Norway

Site Status

Grue municipality

Kirkenær, , Norway

Site Status

Levanger municipality

Leira, , Norway

Site Status

Lyngdal municipality

Lyng, , Norway

Site Status

Lyngdal municipality

Lyngdal, , Norway

Site Status

Bærum municipality

Rud, , Norway

Site Status

Salten municipality

Sjøvegan, , Norway

Site Status

Stavanger municipality

Stavanger, , Norway

Site Status

Trondheim municipality

Trondheim, , Norway

Site Status

Vadsø municipality

Vadsø, , Norway

Site Status

Countries

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Norway

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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16/54571

Identifier Type: -

Identifier Source: org_study_id

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