Project IntERact V2

Not Applicable

Completed

• Conditions: Injury Prevention; Firearm Violence; Firearm Carriage

• Registration Number: NCT05109325
• Lead Sponsor: University of Michigan

Brief Summary

The present study is evaluating the efficacy of a behavioral intervention to reduce risky firearm carriage among a high risk sample of youth reporting recent firearm carriage and ownership of a smartphone.

Detailed Description

Firearms are the leading cause of death for U.S. youth; 60% due to homicide. This study will test the efficacy of a behavioral intervention at reducing risky firearm behaviors among a high-risk community sample of youth (age 16-24) that report past 3-month firearm carriage and smartphone ownership. The behavioral intervention consists of 3 remotely delivered therapy sessions integrating motivational interviewing (MI), cognitive behavioral therapy (CBT), and care management (CM), supported by a smartphone APP that facilitates therapist contact, conducts automated daily assessments, delivers between session tailored therapy content, delivers just-in-time Global Positioning System (GPS)-triggered notifications upon entry into high-risk locations, and aids with utilization of local resources. Recruitment will proceed in two high-risk communities (Flint, Saginaw), including through the main Emergency Departments/trauma centers that are located in both cities. Given elevated rates of firearm violence among socio-disadvantaged youth with disparities in access to community services, the proposed intervention, if found to be efficacious, has the potential for significant public health impact.

Study Timeline

• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-05
• Study Start: 2022-01-24
• Primary Completion: 2025-05-15
• Study Completion: 2025-05-15
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-28
• Last Update Posted: 2025-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

Inclusion Criteria

• Flint or Saginaw Youth between the ages of 16 to 30 reporting past 3-month firearm carriage and ownership of a smartphone, including those seeking care for any reason at Hurley Medical Center or Covenant Medical Center Emergency Department.
• Can provide consent (age: 18-30) or youth assent and parental consent (age: 16-17) for the study.

Exclusion Criteria

• Incarcerated (i.e., in active policy custody and not able to provide informed consent)
• Presenting to the ED for active suicide ideation or attempt, sexual assault, and/or child abuse
• Unable to provide informed consent due to mental status (e.g., alcohol intoxication, acute psychosis) or medical instability.
• Participants will be excluded if firearm carriage is exclusively for legal work (e.g., police), hunting, or target shooting.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Risky Firearm Behaviors	Baseline to 3 months and 6 months	Composite measure used in prior work (Carter 2019). Composite measure uses items from the Tulane University Youth Study and Conflict Tactics Scale capturing frequency and severity of risky firearm-related behaviors (e.g. carriage, threats, use, etc.). (0=Never; 6=20+ Times)

Secondary Outcome Measures

Name	Time	Method
Change in Aggression	Baseline to 3 months and 6 months	Aggression will be measured at Baseline, 3 months, 6 months. Conflict Tactic Scale measures have been used in prior work and is scored using a summary scale. (0=Never; 6=20+ Times).
Change in Victimization	Baseline to 3 months and 6 months	Victimization will be measured at Baseline, 3 months, 6 months. Conflict Tactic Scale measures have been used in prior work and is scored using summary scale (0=Never; 6=20+ Times).

Trial Locations

Locations (3)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Hurley Medical Center; 🇺🇸 Flint, Michigan, United States

Covenant Medical Center; 🇺🇸 Saginaw, Michigan, United States