Lending a Hand to Our Future: PTSD in Refugee Children and Youth (LHOF)
Primary Purpose
Post-Traumatic Stress Disorder
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NET TX
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring PTSD, Refugee children mental health, community health care
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NET TX
Delayed TX
Arm Description
Behavioral intervention for PTSD (NET/KIDNET) with 8-12 sessions administered on a weekly basis.
Behavioral intervention for PTSD (NET/KIDNET) with 8-12 sessions administered on a weekly basis, started following a three-month wait period
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02334566
First Posted
December 30, 2014
Last Updated
January 31, 2019
Sponsor
Unity Health Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT02334566
Brief Title
Lending a Hand to Our Future: PTSD in Refugee Children and Youth
Acronym
LHOF
Official Title
Lending a Hand to Our Future: Documenting, Assessing and Treating Posttraumatic Stress Disorder in Refugee Children and Youth
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Inability to complete study according to protocol
Study Start Date
August 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Refugee children and youth are at high risk for post-traumatic stress disorder (PTSD) and related psychological distress potentially interfering with optimal adjustment and development in the host country. Following extensive efforts and a workshop by the Partnership for Health System Improvement Initiative, comprised of researchers, decision makers, practitioners, immigrant service agencies and related community groups in Ontario, it was determined that research addressing this at-risk population is a priority area. The current study addresses this urgent need by aiming to enhance the health system's capacity in relation to the needs of one of Canada's most vulnerable population. As local refugee settlement continue to rise and reported rates for PTSD in refugee children and youth remain startling; often intensified by historical traumatic factors such as the intensity of exposure to war and other atrocities prior to migration, it is essential to research this highly vulnerable population. In particular, a need exists for research, such as the current study, that specifically documents, assesses and treats PTSD in refugee children and youth, thereby increasing knowledge in the community and preventing further negative outcomes by improving education and health care systems. 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. The current proposal describes a research study to address the needs of this at-risk population through pilot testing of the feasibility of providing PTSD intervention within two school-based primary health care programs and an inner city youth shelter in Toronto. The results will contribute to our understanding of the feasibility of a model of intervention, which can be made available for use in other jurisdictions of Ontario and across Canada to improve adjustment and prevent mental health problems.
This is research project will utilize a randomized clinical trial of treatment for PTSD. It includes refugee children and youth, between the ages of 7 and 15, from two established MHSPI clinics, which currently serve approximately 40 schools, with a total school-aged population of more than 20,000 as well as youth between the ages of 16 and 19 from Covenant House. This study will draw on established measures for PTSD mental health and trauma histories through the use of standardized rating scales and interview methods. Interpreters will be made available and sensitivity adjustments for language and culture will be made. Research assistants will be trained to administer the UCLA screening instruments for PTSD to identify potential contributing or mediating factors of outcome . In addition, paediatricians will be trained in the UCLA diagnostic process to provide case identification, and graduate/medical students will be trained in NET/KIDNET, to facilitate implementation and evaluation of the treatment procedures. All children and youth enrolled at the two MSPHI and Covenant House clinics will placed into one of 3 groups: 'refugee', 'other immigrant' and 'native-born', and be screened for PTSD. All study participants, with a score of 15 or higher, as recommended by the UCLA group, will then be included in the next phase which consists of in depth clinical assessment. Of these participants who are identified as PTSD diagnostic cases are then included in the treatment evaluation phase: randomized into the control- treatment groups and placed into gender-paired therapeutic dyads, i.e. female therapists will be paired with female children and adolescents with PTSD and males with males. Ten male and 10 female therapists will take part in the project and each will be assigned to treat 20 people with PTSD, resulting in a total estimated treated study sample of 400. The control group participants will proceed to the exact same treatment procedures following a three-month wait. All participants included in the treatment groups, either immediate or waiting list control, will receive 3, 6 and 12 month follow-up assessments to evaluate PTSD symptoms using the same UCLA measurements to screen initially. All data will be collected, coded and analyzed using standard statistical analyses appropriate to the research design.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
PTSD, Refugee children mental health, community health care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
588 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NET TX
Arm Type
Experimental
Arm Description
Behavioral intervention for PTSD (NET/KIDNET) with 8-12 sessions administered on a weekly basis.
Arm Title
Delayed TX
Arm Type
Active Comparator
Arm Description
Behavioral intervention for PTSD (NET/KIDNET) with 8-12 sessions administered on a weekly basis, started following a three-month wait period
Intervention Type
Behavioral
Intervention Name(s)
NET TX
Intervention Description
Intervention procedures are a behavioral intervention (NET & KIDNET) with 8-12 sessions administered on a weekly basis.
Primary Outcome Measure Information:
Title
Change in UCLA-PTSD-RI (UCLA-Posttraumatic Stress Disorder-Reaction Index)
Description
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.
Time Frame
week 1, week 12, week 24, week 48, week 64
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morton Beiser, M.D.
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Dataset is incomplete and not usable
Learn more about this trial
Lending a Hand to Our Future: PTSD in Refugee Children and Youth
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