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临床试验/NCT03822598
NCT03822598已完成不适用

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

Norwegian Institute of Public Health16 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2017年6月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
170
试验地点
16
主要终点
Children's Revised Impact of Event Scale (CRIES-13)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Psychosis,
  • Mental disabilities

研究组 & 干预措施

Intervention group

Experimental

Teaching Recovery Techniques implemented 1- 3 weeks after recruitment

干预措施: Teaching Recovery Techniques, TRT (Behavioral)

Wait-list control group

Active Comparator

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

干预措施: Teaching Recovery Techniques, TRT (Behavioral)

结局指标

主要结局

Children's Revised Impact of Event Scale (CRIES-13)

时间窗: 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)

次要结局

  • 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.)

研究者

发起方
Norwegian Institute of Public Health
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Brit Oppedal

Principal Investigator

Norwegian Institute of Public Health

研究点 (16)

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