Post-Traumatic Stress Disorder Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04317820 -
Deep Brain Reorienting in Post-traumatic Stress Disorder
|
N/A | |
Completed |
NCT05112003 -
Translingual Neurostimulation for the Virtual Treatment of Post-Traumatic Stress Disorder: A Feasibility Pilot
|
N/A | |
Recruiting |
NCT04518267 -
Anger and Psychotrauma: Data From Military and Civilians
|
||
Completed |
NCT02502604 -
Cognitive Training Program for Individuals With Depression and Post-Traumatic Stress Disorder
|
N/A | |
Completed |
NCT02256566 -
Cognitive Training for Mood and Anxiety Disorders
|
N/A | |
Terminated |
NCT02234687 -
A mGlu2/3 Agonist in the Treatment of PTSD
|
Phase 1 | |
Completed |
NCT02213900 -
Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy
|
Phase 4 | |
Completed |
NCT01738308 -
The Effects of Healing Touch on Post Operative Pediatric Patients
|
N/A | |
Terminated |
NCT02520726 -
PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims
|
Phase 4 | |
Completed |
NCT01517711 -
Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)
|
Phase 4 | |
Completed |
NCT01437891 -
Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF)
|
N/A | |
Completed |
NCT01199107 -
Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD)
|
Phase 3 | |
Completed |
NCT01998100 -
Maximizing Treatment Outcome in Post-Traumatic Stress Disorder (PTSD)
|
Phase 3 | |
Completed |
NCT01231711 -
Improving Quality-of-life and Depressive Symptoms of Combat Veterans Via Internet-based Intervention
|
Phase 1 | |
Completed |
NCT00680524 -
Telephone-based Care for OEF/OIF Veterans With PTSD
|
N/A | |
Completed |
NCT00838006 -
Psychophysiologic Predictors of Post-deployment Mental Health Outcomes
|
N/A | |
Completed |
NCT00348036 -
Group Intervention for Interpersonal Trauma
|
N/A | |
Completed |
NCT00525226 -
Evaluating the Effects of Stress in Pregnancy
|
N/A | |
Completed |
NCT00158262 -
Effect of Propranolol on Preventing Posttraumatic Stress Disorder
|
Phase 4 | |
Completed |
NCT00183690 -
Prolonged Exposure Therapy Versus Active Psychotherapy in Treating Post-Traumatic Stress Disorder in Adolescents
|
Phase 1 |