Project IntERact V2

University of Michigan

Status: Completed

Conditions: Firearm Carriage; Firearm Violence; Injury Prevention

Treatments: Behavioral: IntERact

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05109325

R01CE003303 (U.S. NIH Grant/Contract)

HUM00188022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 373 patients

Sex: All

Ages: 16 to 30 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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373 participants in 2 patient groups

Enhanced usual care + assessment

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: IntERact