NCT02334566

Brief Summary

Immigrant and refugee children and youth are the fastest growing segment of Canadian society, but their mental health is too often overlooked even though their high rates of symptoms are increasingly of concern. These children and youth face the same developmental challenges as other children, but migration and resettlement amplify challenges and also create additional risks. Although a literature about the effects of immigrant family life on the mental health of children exists, very little research has examined the specific extent and implications of post-traumatic stress disorder (PTSD) among refugee children and youth. In addition, the best practice intervention strategies that most optimally support their mental health difficulties have not been evaluated. This study investigates the effectiveness of a treatment intervention in a sample of refugee children: Narrative Exposure Therapy or NET and KIDNET (developed for younger children), selected due to their documented superiority relative to other forms of treatment for children and youth with PTSD.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
588

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 8, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

1.8 years

First QC Date

December 30, 2014

Last Update Submit

January 31, 2019

Conditions

Keywords

PTSDRefugee children mental healthcommunity health care

Outcome Measures

Primary Outcomes (1)

  • Change in UCLA-PTSD-RI (UCLA-Posttraumatic Stress Disorder-Reaction Index)

    Although treatment interventions exist for PTSD, the many unique challenges faced by refugee populations are often overlooked. Narrative Exposure Therapy (NET or KIDNET), designed to restore agency and provide symptom relief, is one intervention for PTSD treatment that can indicate positive outcomes for refugee populations.

    week 1, week 12, week 24, week 48, week 64

Study Arms (2)

NET TX

EXPERIMENTAL

Behavioral intervention for PTSD (NET/KIDNET) with 8-12 sessions administered on a weekly basis.

Behavioral: NET TX

Delayed TX

ACTIVE COMPARATOR

Behavioral intervention for PTSD (NET/KIDNET) with 8-12 sessions administered on a weekly basis, started following a three-month wait period

Behavioral: NET TX

Interventions

NET TXBEHAVIORAL

Intervention procedures are a behavioral intervention (NET \& KIDNET) with 8-12 sessions administered on a weekly basis.

Delayed TXNET TX

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All referrals, to the school-based health centers (SBHC) at Parkdale and Sprucecourt schools, through the school support team (SST), individual teachers, parents or community contacts.
  • SBHC children and youth between the ages of 7 and 16 years of age
  • All referrals to Covenant House for youth between 16 and 18 years of age (up to 19th birthday)
  • Assessed to qualify for either Refugee status or Immigrant status, and who request participation and consent to research procedures
  • Participants with a score of 15 or higher on UCLA PTSD-RI and are case identified (diagnosed) by paediatricians for PTSD

You may not qualify if:

  • Participants with a score on the UCLA-PTSD-RI lower than 15.
  • Participants with a score on the UCLA-PTSD-RI higher than 15 and diagnosed with PTSD by paediatrician
  • Participants identified as native born
  • Participants with known (previously identified) disorders that impact on communication and/or cognition, such as Developmental Disability, Autism, Communication Disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Morton Beiser, M.D.

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2014

First Posted

January 8, 2015

Study Start

August 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

February 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Dataset is incomplete and not usable