Project IntERact V2

Not Applicable

Recruiting

• Conditions: Injury Prevention; Firearm Violence; Firearm Carriage
• Interventions: Behavioral: IntERact

• 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IntERact	IntERact	Participants will receive three remotely delivered behavioral therapy sessions (combining motivational interviewing, cognitive behavioral skills training, and care management), with an smartphone APP supporting the therapy and delivering therapeutic content in-between therapy sessions.

Primary Outcome Measures

Name	Time	Method
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).
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)
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).

Trial Locations

Locations (3)

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

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

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