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

NCT03822598 | Completed

• 1 other identifier: 16/54571
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

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

Keywords

Teaching Recovery Techniques; Asylum-seeking children; Refugee children; Low-threshold intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Screen for Child Anxiety Related Disorders (SCARED). 9 items tapping symptoms of generalized anxiety disorder, and 7 items tapping symptoms of social anxiety

  Change in SCARED-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.

• Cantril Ladder

  Change in scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.

• Montgomery-Aasberg Depression Scale, MADRS

  Change in MADRS-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.

Study Arms (2)

Intervention group

EXPERIMENTAL

Teaching Recovery Techniques implemented 1- 3 weeks after recruitment

Behavioral: Teaching Recovery Techniques, TRT

Wait-list control group

ACTIVE COMPARATOR

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

Behavioral: Teaching Recovery Techniques, TRT

Interventions

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

Intervention group; Wait-list control group

Eligibility Criteria

• Age: 8 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Psychosis,
• Mental disabilities

Sponsors & Collaborators

• Norwegian Institute of Public Health: lead
• University of Tromso: collaborator
• University of Bergen: collaborator
• Norwegian Directorate of Children, Youth, and Family Affairs: collaborator
• Norwegian Directorate of Immigration: collaborator
• Norwegian Directorate of Integration and Diversity: collaborator

Study Sites (16)

Bergen Municipality

Bergen, Norway

Location

Nordre Land municipality

Dokka, Norway

Location

Drammen Municipality

Drammen, Norway

Location

Engerdal Municipality

Drevsjø, Norway

Location

Fredrikstad municipality

Fredrikstad, Norway

Location

Gjøvik municipality

Gjøvik, Norway

Location

Ringerike Municipality

Hønefoss, Norway

Location

Grue municipality

Kirkenær, Norway

Location

Levanger municipality

Leira, Norway

Location

Lyngdal municipality

Lyng, Norway

Location

Lyngdal municipality

Lyngdal, Norway

Location

Bærum municipality

Rud, Norway

Location

Salten municipality

Sjøvegan, Norway

Location

Stavanger municipality

Stavanger, Norway

Location

Trondheim municipality

Trondheim, Norway

Location

Vadsø municipality

Vadsø, Norway

Location

MeSH Terms

Conditions

Mental Disorders; Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 30, 2019
• Study Start: June 20, 2017
• Primary Completion: May 31, 2018
• Study Completion: June 30, 2018
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

NO (16)