search
Back to results

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
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

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

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 30, 2014
    Last Updated
    January 31, 2019
    Sponsor
    Unity Health Toronto
    Collaborators
    Canadian Institutes of Health Research (CIHR)
    search

    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

    We'll reach out to this number within 24 hrs