Project IntERact V2

Injury Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05109325
• Other study ID #: HUM00188022
• Secondary ID: R01CE003303
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2022
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: Lynn Massey
• Phone: 734-615-8706
• Email: lsmassey[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Injury Prevention

Intervention

Behavioral:
• IntERact
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).

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	Covenant Medical Center	Saginaw	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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