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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05109325
Other study ID # HUM00188022
Secondary ID R01CE003303
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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