ViolenceNCT02573480
Optimization Study of the Wraparound Care for Youth Injured by Violence Program
A study testing Wraparound care in people with Violence and Violence, Non-accidental, run by University of Manitoba at 1 site in Canada.
Trial summary
This study is an optimization study to evaluate how a wraparound program for youth who have been injured by violence helps to change violence related attitudes and beliefs, change individual risk factors for violence and reduce the risk of future injury due to violence. Read more about this study
- Who is it for?
- Ages 14 to 24 years
- Conditions the study is for
- Violence, Violence, Non-accidental, Physical Violence
- What is being tested?
- Wraparound care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to May 2018
- 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 14 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study is an optimization study to evaluate how a wraparound program for youth who have been injured by violence helps to change violence related attitudes and beliefs, change individual risk factors for violence and reduce the risk of future injury due to violence. Wraparound care involves linking the youth with a support worker who will work with the youth to develop positive support networks and help them link with services that address risk factors towards future violence.
Read the 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.
- Conditions
- Violence, Violence, Non-accidental, Physical Violence
- Being tested
- Wraparound care
- Keywords
- youth violence, intervention, emergency medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wraparound careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Wraparound Care | Experimental | Wraparound care initiated in the ED at the time of injury and continuing for approximately 1 year in the community. Receives: Behavioral: Wraparound care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Violence risk scores
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.
Measured: 1 year post injury
Secondary outcomes (9)
Report risk/protective factors of youth injured by violence
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.
Measured: Within 1 month post injury
Prevalence of post-traumatic stress disorder (PTSD) among participants
As indicated by PTSD Checklist - Civilian Version (PCL-C) and Structured Interview of Disorders of Extreme Stress (SIDES)
Measured: Within 1 month post injury
Prevalence of depression/mental health conditions among participants
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.
Measured: Within 1 month post injury
Prevalence of adverse childhood events (ACE) among participants
As determined by scores on the Adverse Childhood Event questionnaire.
Measured: Within 1 month post injury
Prevalence of alcohol use disorder among participants
As determined by scores on the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C).
Measured: Within 1 month post injury
Prevalence of (non-alcohol) substance use among participants
As determined by scores on the Drug Use Questionnaire (DAST-10, Adolescent Version).
Measured: Within 1 month post injury
Intensity-of-care measurements
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.
Measured: 1 year post-injury
Rate of past year and post year visits to hospital for injury/substance use/mental health
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.
Measured: 1 year pre and post injury
Effect of EDVIP on resilience and post traumatic growth
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.
Measured: 6 months and 1 year post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2018
- Study completionMay 2018
Why it stopped: Loss of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ViolenceStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Carolyn Snider, University of Manitoba
- Investigators
- Carolyn Snider, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573480
- Sponsor's protocol ID
- H2015:311
- Status last verified
- Aug 2018
- First submitted
- 8 Oct 2015
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization Study of the Wraparound Care for Youth Injured by Violence Program
- ClinicalTrials.gov ID
- NCT02573480
- Acronym / sponsor ID
- H2015:311
- Conditions
- Violence, Violence, Non-accidental, Physical Violence
- Keywords
- youth violence, intervention, emergency medicine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of Funding
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 9 Oct 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.
This study is an optimization study to evaluate how a wraparound program for youth who have been injured by violence helps to change violence related attitudes and beliefs, change individual risk factors for violence and reduce the risk of future injury due to violence. Wraparound care involves linking the youth with a support worker who will work with the youth to develop positive support networks and help them link with services that address risk factors towards future violence.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wraparound Care | Experimental | Behavioral: Wraparound careWraparound care initiated in the ED at the time of injury and continuing for approximately 1 year in the community. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Wraparound careWraparound 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. | Behavioural | Wraparound Care |
Primary outcome
Violence risk scores
Time frame: 1 year post injury
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.
9 secondary outcomes
Report risk/protective factors of youth injured by violence
Time frame: Within 1 month post injury
Prevalence of post-traumatic stress disorder (PTSD) among participants
Time frame: Within 1 month post injury
Prevalence of depression/mental health conditions among participants
Time frame: Within 1 month post injury
Prevalence of adverse childhood events (ACE) among participants
Time frame: Within 1 month post injury
Prevalence of alcohol use disorder among participants
Time frame: Within 1 month post injury
Prevalence of (non-alcohol) substance use among participants
Time frame: Within 1 month post injury
Intensity-of-care measurements
Time frame: 1 year post-injury
Rate of past year and post year visits to hospital for injury/substance use/mental health
Time frame: 1 year pre and post injury
Effect of EDVIP on resilience and post traumatic growth
Time frame: 6 months and 1 year post injury
Results and safety
The study was stopped early (reason given: Loss of Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
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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.
Carolyn Snider, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wraparound care in people with Violence and Violence, Non-accidental, run by University of Manitoba at 1 site in Canada.
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 1 inclusion and 1 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 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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: Loss of Funding). 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?
Violence risk scores (time frame: 1 year post injury). 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 9 Aug 2018.