Clinical Screening for Firearm Violence Risk

Sponsor
University of Michigan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05436457
Collaborator
Centers for Disease Control and Prevention (U.S. Fed)
1,500
4
25.2
375
14.9

Study Details

Study Description

Brief Summary

The purpose of the proposed work is to harness cutting-edge machine learning methods to optimize prediction of future firearm violence in youth ages 18-24 so that prevention resources can be allocated efficiently.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Firearm violence is a public health crisis in the United States, and new epidemiological data suggest we may have reached a new endemic level of firearm mortality in recent years. Youth are disproportionately affected by firearm violence, with those age 18-24 being demonstrably the highest risk group. This study will recruit 1,500 youth age 18-24 from urban emergency departments (EDs) in three broadly different locales-Flint, Philadelphia, and Seattle-and administer a baseline survey covering several domains of potential risk factors for future violence, and follow up with those youth at 6- and 12-months to ascertain the primary outcome-firearm violence involvement (as victim or perpetrator, including threats and sub-clinical injuries)-as well as the secondary outcomes: high-risk firearm behaviors, non-firearm violence, and violent injury. This work will generate new insights into the prediction of firearm violence, and will lay the ground for future research involving the development and testing of interventions for interpersonal firearm violence both by identifying potential high-leverage modifiable predictive factors, and by focusing on youth most in need of intervention.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Multi-site External Validation and Improvement of a Clinical Screening Tool for Future Firearm Violence
    Actual Study Start Date :
    Jul 26, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    18-24 Year Olds in Emergency Department

    Individuals age 18-24 recruited from one of the four study sites in Flint (1 hospital), Seattle (1 hospital), and Philadelphia (2 hospitals)

    Outcome Measures

    Primary Outcome Measures

    1. Firearm Violence Involvement [1 Year After Baseline ED Visit]

      The primary outcome for this study is firearm violence involvement, as perpetrator or victim. The primary outcome will be a binary indicator comprised of any affirmative response to the six questions asked as part of items 1-3, or any firearm events found from the objective chart review. Two self-reported measurements of firearm violence perpetration adapted from the modified conflict tactics scale (CTS-2). Two self-reported measurements of firearm violence victimization adapted from the modified conflict tactics scale (CTS-2). Presentation to the emergency department for a firearm injury (ICD-10 codes: X72-X74, W32-W34, X93-X95), measured based on objective chart review during the one year following baseline.

    Secondary Outcome Measures

    1. Risky Firearm Behaviors [1 Year After Baseline ED Visit]

      As established by Carter et al based on a) twelve items from the Tulane Youth Study that measure firearm carriage and discharge in high-risky situations (e.g., discharging a firearm while committing a crime, or carrying a firearm while using drugs); b) the four firearm violence perpetration/victimization outcomes listed under the primary outcome; and c) firearm violence threats (as victim or perpetrator), as measured by the modified conflict tactics scale (CTS-2)

    2. Non-Firearm Violence [1 Year After Baseline ED Visit]

      22 self-reported measurements for non-firearm violence perpetration (11 for partner, 11 for non-partner) adapted from the CTS-2, 22 self-reported measurements for non-firearm violence victimization (11 for partner, 11 for non-partner) adapted from the CTS-2, and 6 items about fighting, adapted from the National Longitudinal Study of Adolescent Health.

    3. Violent Injury [1 Year After Baseline ED Visit]

      Presentation to the emergency department for any violent injury, measured based on objective chart review during the one year following baseline.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 24 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Flint, Philadelphia, or Seattle Youth between the ages of 18-24 seeking care for any reason at Hurley Medical Center, the Hospital of University of Pennsylvania, Penn Presbyterian Medical Center, or Harborview Medical Center Emergency Department

    • Can provide consent for the study

    Exclusion Criteria:
    • Do not understand English (<1% in prior work)

    • Unable to provide consent due to mental status (e.g., alcohol intoxication, acute psychosis) or medical instability.

    • ED visit requiring intensive psychosocial services (e.g., sexual assault, psychosis, active suicidal ideation, or child abuse)

    • In active police custody/prisoners (as they cannot provide consent)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hurley Medical Center Flint Michigan United States 48503
    2 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    3 Penn Presbyterian Medical Center Philadelphia Pennsylvania United States 19104
    4 Harborview Medical Center Seattle Washington United States 98104

    Sponsors and Collaborators

    • University of Michigan
    • Centers for Disease Control and Prevention

    Investigators

    • Principal Investigator: Jason E. Goldstick, PHD, University of Michigan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jason E. Goldstick, Research Associate Professor, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT05436457
    Other Study ID Numbers:
    • HUM00188023
    • 1R01CE003294-01
    First Posted:
    Jun 29, 2022
    Last Update Posted:
    Jun 29, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jason E. Goldstick, Research Associate Professor, University of Michigan

    Study Results

    No Results Posted as of Jun 29, 2022