Project IntERact V2

NCT05109325 | Completed

• 2 other identifiers: HUM00188022R01CE003303
• Study Type: interventional
• Target: 373
• Locations: 1 country
• Sites: 3

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.

Conditions

Firearm Violence; Firearm Carriage; Injury Prevention

Keywords

Emergency Department

Outcome Measures

Primary Outcomes (1)

• Change in Risky Firearm Behaviors

  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)

  Baseline to 3 months and 6 months

Secondary Outcomes (2)

• Change in Aggression

  Baseline to 3 months and 6 months

• Change in Victimization

  Baseline to 3 months and 6 months

Study Arms (2)

Enhanced usual care + assessment

NO INTERVENTION

Daily assessments (without delivery of intervention components) will be conducted with EUC participants and they will receive a brochure with violence, substance use, and mental health resources.

IntERact

EXPERIMENTAL

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.

Behavioral: IntERact

Interventions

IntERact BEHAVIORAL

The IntERact intervention includes: (1) three remotely delivered Health Coach therapist sessions that integrate behavioral therapy (motivational interviewing \[MI\] + cognitive behavioral therapy \[CBT\] and strengths-based care management (CM); as well as, (2) an APP supporting and enhancing the therapist intervention by: (a) conducting automated daily assessments; (b) delivering daily MI/CBT messages tailored by the daily surveys; (c) delivering GPS-enabled alert notifications and immediate one-touch pro-social support; (d) providing access to reminders regarding goals/strengths from the ED session, CBT tools/skills (e.g., infographics, coping strategies, harm reduction strategies), and other psychoeducation (e.g., safe storage); (e) facilitating one-touch contact with pro-social support, including the health coach and others; (f) providing easy linkage to care management resources (web links, phone numbers, contact information).

IntERact

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (3)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Covenant Medical Center

Saginaw, Michigan, 48602, United States

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Carter, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Emergency Medicine; Center Director, OVPR Institute of Firearm Research

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 5, 2021
• Study Start: January 24, 2022
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)