Clinical trial NCT03822598: Promoting Asylum-seeking and Refugee Children's Coping With Trauma
Official title: Implementation and Evaluation of Teaching Recovery Techniques (TRT) Among Asylum-seeking and Refugee Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: University of Tromso
name: University of Bergen
name: Norwegian Directorate of Children, Youth, and Family Affairs
name: Norwegian Directorate of Immigration
name: Norwegian Directorate of Integration and Diversity
First posted: 2019-01-30
Enrollment: 170
Sex: ALL
Minimum age (years): 8
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Children's Revised Impact of Event Scale (CRIES-13)
timeFrame: Change in CRIES-13 scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
Secondary outcomes:
measure: Screen for Child Anxiety Related Disorders (SCARED). 9 items tapping symptoms of generalized anxiety disorder, and 7 items tapping symptoms of social anxiety
timeFrame: Change in SCARED-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
measure: Cantril Ladder
timeFrame: Change in scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
measure: Montgomery-Aasberg Depression Scale, MADRS
timeFrame: Change in MADRS-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Bergen Municipality
city: Dokka
country: Norway
facility: Nordre Land municipality
city: Drammen
country: Norway
facility: Drammen Municipality
city: Drevsjø
country: Norway
facility: Engerdal Municipality
city: Fredrikstad
country: Norway
facility: Fredrikstad municipality
city: Gjøvik
country: Norway
facility: Gjøvik municipality
city: Hønefoss
country: Norway
facility: Ringerike Municipality
city: Kirkenær
country: Norway
facility: Grue municipality
city: Leira
country: Norway
facility: Levanger municipality
city: Lyngdal
country: Norway
facility: Lyngdal municipality
city: Lyng
country: Norway
facility: Lyngdal municipality
city: Rud
country: Norway
facility: Bærum municipality
city: Sjøvegan
country: Norway
facility: Salten municipality
city: Stavanger
country: Norway
facility: Stavanger municipality
city: Trondheim
country: Norway
facility: Trondheim municipality
city: Vadsø
country: Norway
facility: Vadsø municipality
Study officials:
References: