Project IntERact V2

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Firearm Violence, Firearm Carriage, Injury Prevention

Intervention / Treatment
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* Behavioral: IntERact


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Enhanced usual care + assessment<br>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. | |
| Experimental: IntERact<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in Aggression | 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). | Baseline to 3 months and 6 months | 
| Change in Victimization | 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). | Baseline to 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergency Department