Recruiting

Observational Study

Sponsor:

Tulane University

Code:

NCT06712940

Conditions

Gun Violence Prevention

Adolescent Behavior

Eligibility Criteria

Sex: All

Age: 16 - 24

Healthy Volunteers: Not accepted

Interventions

Motivational Interviewing and Firearm Safety Training, with Case Management

Study Details

Brief summary:

This study is a quasi-experimental design, specifically a non-randomized controlled trial (NCT) designed to test the effects of gun violence reduction intervention including MI for youth ages 16-24 years old who present to the Emergency Department or ICU Spirit of Charity Trauma Center (SCTC) at University Medical Centers or another area hospital in New Orleans, Louisiana following a gunshot injury or stab wound. The study will utilize an enrollment strategy that involves alternating, across recruitment days, the assigned study condition. Thus, Day 1 participants would be enrolled into TAU, Day 2 participants would be enrolled in MI-case management condition, Day 3 participants would be enrolled in TAU, etc. This proposed design will minimize any confounds associated with self-selection while possibly increasing enrollment rate.

Research questions include:

1. Will youth allocated to the MI prevention condition have safer firearm related behaviors and beliefs compared to the TAU control condition at 6 months post- enrollment?
2. Will youth allocated to the MI prevention condition have reduced gun violence recidivism compared to the TAU control condition at 18 months post-enrollment.
3. How do youth's social and normative environments influence their gun behaviors and attitudes?

Researchers will compare intervention and TAU arms to see if there are any differences in outcome measures.

Participants will:

1. complete study eligibility assessment, be assigned to one of two conditions depending on the date of assessment, consent, and enroll in the Emergency Department (ED) or inpatient unit of hospital by a study team member,
2. participate in one of two conditions: MI administered by a licensed clinical social worker, or treatment as usual control group (TAU) administered by a study team member (n=170 per condition)
3. complete three surveys (baseline, 3-month, and 6-month) conducted by a study team member
4. 18-month post examination of participant hospital records
5. have the option to complete a 1-1.5 hour interview, 1-3 months after the 6-month survey is completed (n=50)

Conditions

Gun Violence Prevention

Adolescent Behavior

Study ID

NCT06712940

Start date

Aug 31, 2022

Status verified date

Feb, 2025

Completion date

Mar 30, 2028

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 24

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 16 to 24 years old
  • gunshot wound, stab wound, or assault related blunt force trauma injury treated at University Medical Center
  • reside in the state of Louisiana
  • capacity to provide voluntary informed consent or assent as approved by the Institutional Review Board of Tulane University

Exclusion Criteria:

  • not voluntarily agreeing to participate
  • not available to participate in study activities in a private room
  • age under 16 or over 24
  • do not reside in the state of Louisiana
  • not acknowledging English as their first language
  • being in the judgment of the trauma surgery service as too physically compromised to participate
  • intellectual disability as estimated by clinician judgment following mental status examination
  • current psychosis as evidenced by structured clinical interview and mental status examination that are administered on as needed basis
  • current legal detention status
  • injury was a result of intimate partner violence
  • does not have the capacity to provide voluntary informed consent or assent as approved by the Institutional Review Board of Tulane University

Study Design

Enrollment

350 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention Condition

The experimental arm condition consists of motivational interviewing with case management and firearm safety training with a licensed clinical social worker (LCSW). Motivational Interviewing (MI) is a participant-centered yet directive method for enhancing readiness to change. The purpose of MI is to help an individual articulate their own reasons and develop their own plans for making behavioral change. MI respects these values of self-determination and self-efficacy, and emphasizes the participant's right to make decisions about change. The firearm safety training (FST) will be led by the team's LCSW and include a brief demonstration, identification of reasons why the participant may or may not practice safe storage, and develop a plan moving forward. The FST will integrate MI techniques throughout the session.

no intervention: Treatment as Usual

Patients assigned to the TAU condition will receive standard care for victims of violence at the Trauma Center. All TAU-assigned patients will be screened by psychiatry consult/liaison staff for posttraumatic symptoms, depression, and substance use. Patients with significant symptoms will be offered pharmacotherapy and/or supportive psychotherapy. Patients will also be provided with a list of community resources available for victims of violence, including mental health and social services.

Patients in TAU will receive the same information sheet (e.g., job training) provided to patients in the MI condition.

Interventions

Motivational Interviewing and Firearm Safety Training, with Case Management

The basic principles of MI as applied to violence risk reduction in victims of gun violence are as follows: Express Empathy, Develop Discrepancy, Roll with Resistance, and Support Self-Determination/Self- Efficacy. MI practitioners offer themselves as a "consultant" while respecting the participant as the real "expert" in their own life. MI also affirms the patient's ability to make changes and communicates trust in the patient's judgments about readiness and plans for change. Motivational interviewing sessions will occur once a month, for six months with a licensed clinical social worker (LCSW).

The LCSW will additionally provide case management over the course of the six month study, and a one time firearm safety training that covers safe storage methods. At the end of the firearm safety training, the participant will be offered a biometric lock box for free.

Primary outcome measure

  • Firearm carriage [ Time Frame: At time of enrollment ]
  • Firearm storage [ Time Frame: At time of enrollment ]
  • Firearm beliefs [ Time Frame: At time of enrollment ]
  • Firearm carriage [ Time Frame: 3 months post-enrollment ]
  • Firearm storage [ Time Frame: 3-months post enrollment ]
  • Firearm beliefs [ Time Frame: 3 months post-enrollment ]
  • Firearm carriage [ Time Frame: 6 months post-enrollment ]
  • Firearm storage [ Time Frame: 6 months post-enrollment ]
  • Firearm beliefs [ Time Frame: 6 months post-enrollment ]

Central Contacts and Locations

Central contacts

Julia M Fleckman, PHD, MPH

504-988-9937jfleckma@tulane.edu

Timothy K Craft, MSW

tcraft@tulane.edu

Locations

Tulane School of Public Health and Tropical Medicine

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Lexie M Contreras, MPH

lornelas@tulane.edu

Principal Investigator:

Julia M Fleckman, PhD

More Information

Sponsor

Tulane University

Last update posted

Feb 17, 2025

Last verified

Feb, 2025

Keywords

  • Firearm
  • Violence prevention
  • Youth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tulane University on 2025-02-17.