At-risk Intervention and Mentoring Evaluation (AIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02174224
Recruitment Status : Recruiting
First Posted : June 25, 2014
Last Update Posted : January 23, 2018
Information provided by (Responsible Party):
Denver Health and Hospital Authority

Brief Summary:
The purpose of this study is to determine if a hospital-based violence intervention programs can make sustainable behavior changes in at-risk youth using two key components, brief intervention at the hospital bedside and case management.

Condition or disease Intervention/treatment Phase
Violence Behavioral: Brief Intervention Behavioral: Case Management Behavioral: Standard Medical Care Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Program Evaluation of a Hospital-based Violence Intervention Program (At-risk Intervention and Mentoring)
Study Start Date : June 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.
Behavioral: Brief Intervention
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.
Behavioral: Case Management
Case management based on needs-assessment. Resource connection and mentoring.
Behavioral: Standard Medical Care
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.

Primary Outcome Measures :
  1. Violence Risk Scale [ Time Frame: 0, 6, 12, 18 months ]
    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.

Secondary Outcome Measures :
  1. Composite Score [ Time Frame: 0, 6, 12, 18 months ]
    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.

  2. School Enrollment [ Time Frame: 0, 6, 12, 18 months ]
    Self-report for school enrollment will be measured and compared among arms.

  3. Hospital Recidivism [ Time Frame: 0, 6, 12, 18 months ]
    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.

  4. Justice System Recidivism [ Time Frame: 0, 6, 12, 18 months ]
    Self-report of criminal history.

  5. Employment [ Time Frame: 0, 6, 12, 18 months ]
    Self-report of employment status.

  6. Resource Utilization [ Time Frame: 0, 6, 12, 18 months. ]
    Self report of resource utilization for health care and social needs.

  7. Mortality [ Time Frame: 0, 6, 12, 18 months ]
    Mortality will be assessed every 6 months.

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02174224

Contact: Sara Muramoto, BS 3036025154
Contact: Katie Bakes, MD 3036025150

United States, Colorado
Denver Health Medical Center Recruiting
Denver, Colorado, United States, 80204
Principal Investigator: Katie Bakes, MD         
Sponsors and Collaborators
Denver Health and Hospital Authority
Principal Investigator: Katie Bakes, MD Denver Health Medical Center

Responsible Party: Denver Health and Hospital Authority Identifier: NCT02174224     History of Changes
Other Study ID Numbers: OJJDP-2013-3579
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Denver Health and Hospital Authority:
At-risk youth
Intentional Injury
Violence Intervention