Post-Traumatic Stress DisorderLHOFNCT02334566
Lending a Hand to Our Future: PTSD in Refugee Children and Youth
A study testing NET TX in people with Post-Traumatic Stress Disorder, run by Unity Health Toronto.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- NET TX
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 588 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Lending a Hand to Our Future: Documenting, Assessing and Treating Posttraumatic Stress Disorder in Refugee Children and Youth
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.
Read the 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.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- NET TX
- Keywords
- PTSD, Refugee children mental health, community health care
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NET TXBehavioural
Intervention procedures are a behavioral intervention (NET \& KIDNET) with 8-12 sessions administered on a weekly basis.
| Study group | Role | What they receive |
|---|---|---|
| NET TX | Experimental | Behavioral intervention for PTSD (NET/KIDNET) with 8-12 sessions administered on a weekly basis. Receives: 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 Receives: Behavioral: NET TX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 1, week 12, week 24, week 48, week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2017
- Study completionJun 2017
Why it stopped: Inability to complete study according to protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 588 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Morton Beiser, M.D., Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334566
- Sponsor's protocol ID
- 06705
- Acronym
- LHOF
- Status last verified
- Jan 2019
- First submitted
- 30 Dec 2014
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Dataset is incomplete and not usable
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lending a Hand to Our Future: Documenting, Assessing and Treating Posttraumatic Stress Disorder in Refugee Children and Youth
- ClinicalTrials.gov ID
- NCT02334566
- Acronym / sponsor ID
- LHOF / 06705
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- PTSD, Refugee children mental health, community health care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to complete study according to protocol
- Enrolment
- 588 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NET TX | Experimental | Behavioral: NET TXBehavioral intervention for PTSD (NET/KIDNET) with 8-12 sessions administered on a weekly basis. |
| Delayed TX | Active comparator | Behavioral: NET TXBehavioral intervention for PTSD (NET/KIDNET) with 8-12 sessions administered on a weekly basis, started following a three-month wait period |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NET TXIntervention procedures are a behavioral intervention (NET \& KIDNET) with 8-12 sessions administered on a weekly basis. | Behavioural | Delayed TX, NET TX |
Primary outcome
Change in UCLA-PTSD-RI (UCLA-Posttraumatic Stress Disorder-Reaction Index)
Time frame: week 1, week 12, week 24, week 48, week 64
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.
Results and safety
The study was stopped early (reason given: Inability to complete study according to protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Individual participant dataSharing planned: No. Dataset is incomplete and not usable
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morton Beiser, M.D. principal investigator
Unity Health Toronto
Questions about this trial
What is this clinical trial studying?
A study testing NET TX in people with Post-Traumatic Stress Disorder, run by Unity Health Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inability to complete study according to protocol). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in UCLA-PTSD-RI (UCLA-Posttraumatic Stress Disorder-Reaction Index) (time frame: week 1, week 12, week 24, week 48, week 64). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.