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Project IntERact V2

IntERact: Preventing Risky Firearm Behaviors Among Urban Youth Seeking Emergency Department Care

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05109325
Enrollment
373
Registered
2021-11-05
Start date
2022-01-24
Completion date
2025-05-15
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Firearm Carriage, Firearm Violence, Injury Prevention

Keywords

Emergency Department

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.

Interventions

BEHAVIORALIntERact

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).

Sponsors

University of Michigan
Lead SponsorOTHER
Centers for Disease Control and Prevention
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 30 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Risky Firearm BehaviorsBaseline to 3 months and 6 monthsComposite 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

MeasureTime frameDescription
Change in AggressionBaseline to 3 months and 6 monthsAggression 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 VictimizationBaseline to 3 months and 6 monthsVictimization 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).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORPatrick Carter, M.D.

University of Michigan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026