Clinical trial NCT05109325: Project IntERact V2
Official title: IntERact: Preventing Risky Firearm Behaviors Among Urban Youth Seeking Emergency Department Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Firearm Violence
Firearm Carriage
Injury Prevention
Keywords: Emergency Department
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2021-11-05
Enrollment: 373
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Risky Firearm Behaviors
timeFrame: Baseline to 3 months and 6 months
measure: Change in Aggression
timeFrame: Baseline to 3 months and 6 months
measure: Change in Victimization
timeFrame: Baseline to 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Saginaw
country: United States
facility: Covenant Medical Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Patrick Carter, M.D.
role: PRINCIPAL_INVESTIGATOR
References: