WrapAround Care for Youth Injured by Violence

The investigators estimate that our sample size for the main trial must be 330 per arm (660 total) (Section 2.11). In order to ensure sufficient recruitment over 44 months plus 12 month follow-up for each subject and analysis time within a 5 year time frame, the investigators estimate that the investigators will need to randomize 180 youth to our pilot study in one year. This will also ensure that each support worker has an appropriate workload (approximately 2 new subjects per month with a maximum of 15 at any time). Successful Recruitment will be defined as >180 participants in one year.

The investigators have set the treatment protocol based on experience from our Proof of Concept study and our community partners. In behavioural interventions, fidelity measures are considered the quality control measure of ensuring the intervention is being implemented as intended. Fidelity preserves internal validity against type I and II errors, it improves power by decreasing the variability in treatment effect and allows replication, dissemination and implementation in practice. Successful Fidelity will be defined as >85% of contacts (i.e. check-ins, phone calls, team meetings) attempted by the support worker.

Participant adherence refers to both the receipt of the intervention (the development of a strong and effective alliance between the case manager and youth) and enacting on the intervention (accessing resources). In behavioural intervention studies it is important to demonstrate that the actual intervention is occurring as designed. If adherence to the intervention is not achieved, then our comparison of outcomes do not truly measure the difference between intervention and control. Successful Adherence will be assessed using the Working Alliance Inventory, which measures the bond between the support worker and participant and the agreement on tasks and goals set.

Given youth injured by violence, especially those who are gang-involved are at high risk of retaliatory violence; investigators must ensure participants do not experience increased harm as part of the intervention. Program staff will discuss adverse events at each weekly meeting and workers and counselors will be required to fill in adverse event forms should they occur. These will be reviewed immediately with the principal investigator and if necessary the Data Safety Monitoring Board (DSMB). The DSMB will review a table of these adverse events and will review serious adverse events (e.g. death or otherwise deemed as serious) in detail. Stopping rules and guidelines are specified for the DSMB. The main stopping rule will be to stop the study if the treatment arm is significantly more likely to suffer a repeat violent injury (p<0.05).

This outcome is designed to determine the cost-effectiveness of this intervention. For this pilot study we will only be including the direct costs of repeat visits to the hospital for injury, substance use and mental health. The purpose of this initial assessment is to support future cost-effectiveness study of our main study.

This will be the primary outcome for our future effectiveness trial - we will measure this in our pilot trial to ensure data is collectible and appropriate for analysis

20% of youth who visit the Winnipeg Health Science EDs for a visit due to violence have a subsequent visit to the same ED for a new injury due to violence in the following year. This is similar to figures from other locations in North America and Europe, which have demonstrated repeat injury rates as high as 40%.

This will be a secondary outcome of our future effectiveness trials - we will measure this in our pilot trial to ensure data is collectible and appropriate for analysis.

Of the youth who had subsequent visits to our EDs for injuries due to violence, 81% had >1 repeat injury and 21% had >2 repeat injuries.8 This outcome will determine if the intervention has an impact on number of repeat intentional injuries.

This will be a secondary outcome of our future effectiveness trials - we will measure this in our pilot trial to ensure data is collectible and appropriate for analysis

One study demonstrated that a person is at highest risk of reinjury in the first 30 days. This outcome will determine if the intervention protects from early repeat reinjury.

This will be a secondary outcome of our future effectiveness trials - we will measure this in our pilot trial to ensure data is collectible and appropriate for analysis

It is hypothesized that subsequent injuries are more severe; however, no literature exists to prove this hypothesis. We will use the Injury Severity Score and the Abbreviated Injury Scale to measure this. This outcome will determine if the intervention protects from more serious repeat injury.

This will be a secondary outcome of our future effectiveness trials - we will measure this in our pilot trial to ensure data is collectible and appropriate for analysis.

This will be a secondary outcome of our future effectiveness trials - we will measure this in our pilot trial to ensure data is collectible and appropriate for analysis

This will be a secondary outcome of our future effectiveness trials - we will measure this in our pilot trial to ensure data is collectible and appropriate for analysis

Education is associated with reduced violence involvement. We will measure whether the youth was enrolled in either high school or post-secondary education at both time of index injury and at the end of one year. This outcome will determine if the intervention is successful in addressing this risk factor.

This will be a secondary outcome of our future effectiveness trials - we will measure this in our pilot trial to ensure data is collectible and appropriate for analysis

Many injured faced a lack of stable housing. This means that the youth is often "couch surfing" or staying in dangerous environments or on the street. We will measure whether the youth was housed in public housing at both time of index injury and at the end of one year.

This will be a secondary outcome of our future effectiveness trials - we will measure this in our pilot trial to ensure data is collectible and appropriate for analysis

Previous incarceration has been associated with increased risk of violent injury and homicide. Other literature demonstrates that violent injury in youth may precede criminal behaviour. We will measure interactions with the Manitoba Justice system in the year prior to the index injury and the year post the index injury to determine if the intervention protects the youth from interactions with Manitoba Justice.

This will be a secondary outcome of our future effectiveness trials - we will measure this in our pilot trial to ensure data is collectible and appropriate for analysis

Some repeat injuries that occur will not be severe enough to require a visit to an ED; youth may visit their family physician, a walk-in-clinic or not require any medical care. We will measure injuries not captured by hospital administrative data and chart review by asking youth to self-report these injuries to determine if the intervention causes changes in self-report of repeat injury.

This will be a secondary outcome of our future effectiveness trials - we will measure this in our pilot trial to ensure data is collectible and appropriate for analysis

Structured activity - as defined as being in school, in job training, employed or volunteering is important to helping youth be more future oriented. We will measure this each month to determine if the intervention causes changes in self-report of structured activity.

This will be a secondary outcome of our future effectiveness trials - we will measure this in our pilot trial to ensure data is collectible and appropriate for analysis

As noted in previous secondary outcomes, safe housing is challenging for our participants. Some may find safe housing through private landlords and therefore not be measured in the administrative database. We will measure their self-report of being safely housed to determine if the intervention promotes safe housing.