NCT02573480

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

2.5 years

First QC Date

October 8, 2015

Last Update Submit

August 7, 2018

Conditions

Keywords

youth violence, intervention, emergency medicine

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year post injury

Secondary Outcomes (9)

  • Report risk/protective factors of youth injured by violence

    Within 1 month post injury

  • Prevalence of post-traumatic stress disorder (PTSD) among participants

    Within 1 month post injury

  • Prevalence of depression/mental health conditions among participants

    Within 1 month post injury

  • Prevalence of adverse childhood events (ACE) among participants

    Within 1 month post injury

  • Prevalence of alcohol use disorder among participants

    Within 1 month post injury

  • +4 more secondary outcomes

Study Arms (1)

Wraparound Care

EXPERIMENTAL

Wraparound care initiated in the ED at the time of injury and continuing for approximately 1 year in the community.

Behavioral: Wraparound care

Interventions

Wraparound careBEHAVIORAL

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.

Wraparound Care

Eligibility Criteria

Age14 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \) 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).

You may not qualify if:

  • \) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winnipeg Health Sciences Centre

Winnipeg, Manitoba, R3P 3E4, Canada

Location

Study Officials

  • Carolyn Snider, MD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 8, 2015

First Posted

October 9, 2015

Study Start

November 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

August 9, 2018

Record last verified: 2018-08

Locations