- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02573480
Optimization Study of the Wraparound Care for Youth Injured by Violence Program
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In Canada, violence is the most common reason for youth (aged 12- 24) to visit an emergency department (ED) and the leading cause of hospitalization among males aged 20 to 24. Injury is a chronic, recurring disease. In Winnipeg, Canada, 20% of youth injured by violence visited the same ED in the next year with a repeat injury due to violence. Currently the standard of care for this vulnerable population is to discharge them from our EDs with no effort to prevent the next injury.
There are 5 components key to implementing wraparound care for youth who are at risk of violence. The 1st component is the establishment of a relationship between support worker and youth at the time of injury - i.e. during a teachable moment. The 2nd component is that the support worker has extensive "lived experience". Many youth affected by violence have been marginalized by society and have significant trust issues with figures of traditional power (i.e. doctors, social workers etc.). It is imperative that the support worker establish trust quickly and act as a role model. The 3rd component is that the care program is individualized for and by each youth. The support worker helps the youth to define their own goals and the steps required to achieve them. The 4th component is to provide trauma-informed care. Trauma-informed care is an approach used by caregivers that acknowledges the current and past traumas a person may have experienced and helps the person heal and build a sense of control over their lives. The final component is the opportunity to access community supports within their own culture.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3P 3E4
- Winnipeg Health Sciences Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1) Age 14 - 24, and 2) Presentation with an injury due to violence (defined as an injury inflicted by someone else and one caused by a gunshot wound, stab wound, blunt object, or bodily force).
Exclusion Criteria:
1) Unable to consent due to language or brain injury, 2) Sexual assault, 3) Child Abuse, 4) Self-Inflicted Injury, or 5) Transfer from hospital > 1 hr from Winnipeg, Canada
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Wraparound Care
Wraparound care initiated in the ED at the time of injury and continuing for approximately 1 year in the community.
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Wraparound care starts by linking an individual with a support worker who works with them to address risk factors and empower the individual to make positive choices.
It not only includes connecting the youth with existing community resources such as education, employment, cultural services and substance counselling, it also helps build problem-solving skills, coping skills, and self-efficacy of the youth and family members.
The support worker provides mentorship to the youth.
Mentorship both teaches and emulates appropriate behaviours with respect to attitudes and behaviours associated with violence.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Violence risk scores
Time Frame: 1 year post injury
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The Violence Risk Scale: Youth Version (YRS-YV) will be completed at intake and then again at 3 months, 6 months and 1 year.
The total change score for each time period will be determined.
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1 year post injury
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Report risk/protective factors of youth injured by violence
Time Frame: Within 1 month post injury
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Many risk and protective factors such as education, employment, family, child protective services, access to health care, addictions, mental health, housing and interaction with the justice system have all been shown to be risk and in some cases protective (active education or employment) factors for violent injury among youth.
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Within 1 month post injury
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Prevalence of post-traumatic stress disorder (PTSD) among participants
Time Frame: Within 1 month post injury
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As indicated by PTSD Checklist - Civilian Version (PCL-C) and Structured Interview of Disorders of Extreme Stress (SIDES)
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Within 1 month post injury
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Prevalence of depression/mental health conditions among participants
Time Frame: Within 1 month post injury
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As indicated by the Patient Health Questionnaire (PHQ-9) Quick Depression Assessment and In addition to the PHQ-9, we will ask youth questions about previous mental health diagnoses to capture non-depression and PTSD diagnoses.
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Within 1 month post injury
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Prevalence of adverse childhood events (ACE) among participants
Time Frame: Within 1 month post injury
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As determined by scores on the Adverse Childhood Event questionnaire.
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Within 1 month post injury
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Prevalence of alcohol use disorder among participants
Time Frame: Within 1 month post injury
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As determined by scores on the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C).
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Within 1 month post injury
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Prevalence of (non-alcohol) substance use among participants
Time Frame: Within 1 month post injury
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As determined by scores on the Drug Use Questionnaire (DAST-10, Adolescent Version).
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Within 1 month post injury
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Intensity-of-care measurements
Time Frame: 1 year post-injury
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Based on a 3-part measurement developed by the Children's Hospital of Philadelphia (CHOP) as well as the more standard intensity measurements of total time used by San Francisco WrapAround care program and Healing Hurt People Program in Philadelphia.
This measurement include: CHOP-method: 1) # of weeks receiving care, 2) # of needs addressed and 3) # of staff-client encounters; Standard Method: Total in-person contact time.
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1 year post-injury
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Rate of past year and post year visits to hospital for injury/substance use/mental health
Time Frame: 1 year pre and post injury
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Using ADT (Admissions, Diagnosis, Triage) and E-Triage and chart review, any visit to any ED in Winnipeg for intentional injury 1-year pre-index visit and 1-year post-index visit will be identified.
Deaths due to violence will be identified using Vital Stats.
Following the identification of a visit to the ED in the year pre and post the index injury (i.e. the injury at which time the youth participant was enrolled), a chart review at that hospital of that year will be completed.
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1 year pre and post injury
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Effect of EDVIP on resilience and post traumatic growth
Time Frame: 6 months and 1 year post injury
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Using Connor Davidson Resilience Scale and PostTraumatic Growth Injury, youth will be assessed for changes in resilience from baseline and posttraumatic growth at two time points.
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6 months and 1 year post injury
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carolyn Snider, MD, University of Manitoba
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H2015:311
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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