- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02174224
At-risk Intervention and Mentoring Evaluation (AIM)
Program Evaluation of a Hospital-based Violence Intervention Program (At-risk Intervention and Mentoring)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will be a randomized controlled trial. Youth presenting to the emergency department with an intentional injury (gunshot wound, stab wound, or assault) will be given a behavioral assessment. Participants will be categorized according to risk (low, moderate, high). Only moderate or high youth will continue in the study and be randomized. Low risk youths will receive the medical standard of care and be re-assessed at 18 months.
Randomization will place participants in one of two arms. Arm 1 will receive the standard of care PLUS a brief intervention with AIM outreach workers. Arm 2 will receive standard medical care PLUS a brief intervention PLUS case management.
Every randomized youth will be assessed for risk and protective factors and have have data collected at 6-month intervals (0, 6, 12, 18 months).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Colorado
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Denver, Colorado, United States, 80204
- Denver Health Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 14-24 years of age , Intentional Injury (Gunshot Wound, Stab Wound, Assault)
Exclusion Criteria:
- Younger than 14, 25 or older, non-English speaking, unable to give informed consent/assent, sexual assaults, domestic violence, child neglect/abuse.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SMC + BI + Case Management
This arm will include all interventions in Standard Medical Care + Brief Intervention Arm.
Case management will also be given to this arm.
General needs based assessments will be conducted by the outreach worker.
These assessments will be done at the hospital or at the youth's home, whichever they prefer.
This assessment tool addresses education, vocational training, employment, housing, medical insurance, follow-up care and pro-social activities.
Although each youth in this arm will receive the same needs-based assessment, individual youth will have variable needs, which will guide each unique and individualized case management plan.
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Goals of the bedside intervention will be to help the patient understand their risky behaviors that resulted in the injury and to assess and deescalate any threat of retaliatory violence by the patient.
The outreach worker will: (1) develop a rapport with the patient by introducing themselves and describing their (outreach worker's) background and reason for the bedside visit; (2) assess the emotional response to the current injury; (3) ensure the patient and/or family understand the nature of the injury and ED course; (4) address any immediate concerns of the patient; and (5) develop a plan for staying safe following discharge.
Case management based on needs-assessment.
Resource connection and mentoring.
This will include physician discretion for medical treatment and potentially a social worker visit as the physician sees fit for the patient.
This will also include a list of resources that are typically needed and used for violently injured youth.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Violence Risk Scale
Time Frame: 0, 6, 12, 18 months
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Violence Risk Scale (VRS) will be measured with each youth at 4 time points.
Change over time will be assessed and compared among study arms.
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0, 6, 12, 18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite Score
Time Frame: 0, 6, 12, 18 months
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Composite Score measures both risk and protective factors.
This weighted scale uses the interplay between risk and protective factors to determine overall risk for youth to become violently injured.
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0, 6, 12, 18 months
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School Enrollment
Time Frame: 0, 6, 12, 18 months
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Self-report for school enrollment will be measured and compared among arms.
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0, 6, 12, 18 months
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Hospital Recidivism
Time Frame: 0, 6, 12, 18 months
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Every six month, patients' medical records will be scanned to determine if there has been violent injury recidivism.
Medical release of Information forms will allow medical record searches from other local hospitals.
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0, 6, 12, 18 months
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Justice System Recidivism
Time Frame: 0, 6, 12, 18 months
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Self-report of criminal history.
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0, 6, 12, 18 months
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Employment
Time Frame: 0, 6, 12, 18 months
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Self-report of employment status.
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0, 6, 12, 18 months
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Resource Utilization
Time Frame: 0, 6, 12, 18 months.
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Self report of resource utilization for health care and social needs.
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0, 6, 12, 18 months.
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Mortality
Time Frame: 0, 6, 12, 18 months
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Mortality will be assessed every 6 months.
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0, 6, 12, 18 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Katie Bakes, MD, Denver Health Medical Center
Study record dates
Study Major Dates
Study Start
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
- OJJDP-2013-3579
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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