NCT05436457

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,506

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

3.1 years

First QC Date

June 22, 2022

Last Update Submit

August 23, 2024

Conditions

Keywords

Injury Prevention

Outcome Measures

Primary Outcomes (1)

  • 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. 1. Two self-reported measurements of firearm violence perpetration adapted from the modified conflict tactics scale (CTS-2). 2. Two self-reported measurements of firearm violence victimization adapted from the modified conflict tactics scale (CTS-2). 3. 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 Outcomes (3)

  • Risky Firearm Behaviors

    1 Year After Baseline ED Visit

  • Non-Firearm Violence

    1 Year After Baseline ED Visit

  • Violent Injury

    1 Year After Baseline ED Visit

Study Arms (1)

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)

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Youth aged 18-24 seeking care at the Emergency departments of Hurley Medical Center, the Hospital of University of Pennsylvania, Penn Presbyterian Medical Center, or Harborview Medical Center

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Study Officials

  • Jason E. Goldstick, PHD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

June 22, 2022

First Posted

June 29, 2022

Study Start

July 26, 2021

Primary Completion

August 22, 2024

Study Completion

August 22, 2024

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

After study completion, de-identified data will be curated and uploaded through the Inter-University Consortium for Political and Social Research (ICPSR) run through the University of Michigan. ICPSR stores, curates, and provides access to data generated through social research studies in service to open science, which acts in service to optimized data sharing, rigorous detailing of study methods and citations for measures, and ensuring long-term preservation of the study data. Through the data curation process, data are cleaned and standardized for use, and data documentation is rigorously developed so that data sets and the associated documentation can be understood at a basic by any potential users. The uploaded data will be de-identified to ensure no linkages to individual research participants and will exclude variables that could lead to deductive disclosure of the identity of any individual subjects.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
After the study is completed, with no specified time for when sharing will end.
Access Criteria
Registration with ICPSR and agreement to follow their rules and policies

Locations