NCT06712940 Supportive Hospital-Based Intervention for Firearm Trauma
| NCT ID | NCT06712940 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tulane University |
| Condition | Gun Violence Prevention |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2022-08-31 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 350 participants in total. It began in 2022-08-31 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility Criteria
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
Contact & Investigator
Julia M Fleckman, PhD, MPH
PRINCIPAL INVESTIGATOR
Tulane University
Frequently Asked Questions
Who can join the NCT06712940 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 24 Years, studying Gun Violence Prevention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06712940 currently recruiting?
Yes, NCT06712940 is actively recruiting participants. Contact the research team at jfleckma@tulane.edu for enrollment information.
Where is the NCT06712940 trial being conducted?
This trial is being conducted at New Orleans, United States.
Who is sponsoring the NCT06712940 clinical trial?
NCT06712940 is sponsored by Tulane University. The principal investigator is Julia M Fleckman, PhD, MPH at Tulane University. The trial plans to enroll 350 participants.