Clinical Screening for Firearm Violence Risk

Firearm Injury Clinical Trial

Official title:

Multi-site External Validation and Improvement of a Clinical Screening Tool for Future Firearm Violence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05436457
• Other study ID #: HUM00188023
• Secondary ID: 1R01CE003294-01
• Status: Active, not recruiting
• Start date: July 26, 2021
• Est. completion date: August 29, 2024

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1506
• Est. completion date: August 29, 2024
• Est. primary completion date: August 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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)

Related Conditions & MeSH terms

• Firearm Injury

Locations

Country	Name	City	State
United States	Hurley Medical Center	Flint	Michigan
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Firearm Violence Involvement	The primary outcome for this study is firearm violence involvement, as perpetrator or victim. This will be measured in part by the Conflict Tactics Scale 2, as established by Straus et al. CTS-2 is comprised of a 6-point scale, measuring how often the respondent has experienced each type of violence, ranging from never to more than 20 times. The primary outcome here will be a binary indicator comprised of any affirmative response to the questions asked as part of items 1-3 below, 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.	1 Year After Baseline ED Visit
Secondary	Risky Firearm Behaviors	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)	1 Year After Baseline ED Visit
Secondary	Non-Firearm Violence	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.	1 Year After Baseline ED Visit
Secondary	Violent Injury	Presentation to the emergency department for any violent injury, measured based on objective chart review during the one year following baseline.	1 Year After Baseline ED Visit