Supportive Hospital-Based Intervention for Firearm Trauma

NCT06712940 | Recruiting

• 2 other identifiers: 2021-1631-UMCU01CE003384-01
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.How do youth's social and normative environments influence their gun behaviors and attitudes?
4. 4.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,
5. 5.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)
6. 6.complete three surveys (baseline, 3-month, and 6-month) conducted by a study team member
7. 7.18-month post examination of participant hospital records
8. 8.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

Keywords

Firearm; Violence prevention; Youth

Outcome Measures

Primary Outcomes (9)

• Firearm carriage

  Frequency of firearm carriage outside of home

  At time of enrollment

• Firearm storage

  Categorical description of firearm storage (locked and loaded, locked and unloaded, unlocked and loaded, unlocked and unloaded)

  At time of enrollment

• Firearm beliefs

  Summary scale of firearm beliefs from a modified version of the Gun Beliefs and Behaviors Scale (GBBS). 7-point Likert scale will be used, and summed to create a composite score where a higher score indicates more positive firearm beliefs. The composite score range will be 0 to 21.

  At time of enrollment

• Firearm carriage

  Frequency of firearm carriage outside of home

  3 months post-enrollment

• Firearm storage

  Categorical description of firearm storage (locked and loaded, locked and unloaded, unlocked and loaded, unlocked and unloaded)

  3-months post enrollment

• Firearm beliefs

  Summary scale of firearm beliefs from a modified version of the Gun Beliefs and Behaviors Scale (GBBS). 7-point Likert scale will be used, and summed to create a composite score where a higher score indicates more positive firearm beliefs. The composite score range will be 0 to 21.

  3 months post-enrollment

• Firearm carriage

  Frequency of firearm carriage outside of home

  6 months post-enrollment

• Firearm storage

  Categorical description of firearm storage (locked and loaded, locked and unloaded, unlocked and loaded, unlocked and unloaded)

  6 months post-enrollment

• Firearm beliefs

  Summary scale of firearm beliefs from a modified version of the Gun Beliefs and Behaviors Scale (GBBS). 7-point Likert scale will be used, and summed to create a composite score where a higher score indicates more positive firearm beliefs. The composite score range will be 0 to 21.

  6 months post-enrollment

Secondary Outcomes (2)

• Arrest records for gun violence

  18 months post study activity completion

• Hospital readmittance for gun violence wounds

  18 months post study activity completion

Study Arms (2)

Intervention Condition

EXPERIMENTAL

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.

Behavioral: Motivational Interviewing and Firearm Safety Training, with Case Management

Treatment as Usual

NO INTERVENTION

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 BEHAVIORAL

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.

Intervention Condition

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tulane University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Tulane School of Public Health and Tropical Medicine

New Orleans, Louisiana, 70112, United States

RECRUITING

Related Publications (8)

• Lundahl BW, Kunz C, Brownell C, Tollefson D, Burke BL. A meta-analysis motivational interviewing: twenty-five years of empirical studies. Research on Social Work Practice. 2010;20(2):137-160.

  BACKGROUND

• Purtle J, Rich JA, Fein JA, James T, Corbin TJ. Hospital-Based Violence Prevention: Progress and Opportunities. Ann Intern Med. 2015 Nov 3;163(9):715-7. doi: 10.7326/M15-0586. Epub 2015 Aug 25. No abstract available.

  PMID: 26301734 BACKGROUND

• Purtle J, Dicker R, Cooper C, Corbin T, Greene MB, Marks A, Creaser D, Topp D, Moreland D. Hospital-based violence intervention programs save lives and money. J Trauma Acute Care Surg. 2013 Aug;75(2):331-3. doi: 10.1097/TA.0b013e318294f518. No abstract available.

  PMID: 23887566 BACKGROUND

• Pino EC, Fontin F, James TL, Dugan E. Mechanism of penetrating injury mediates the risk of long-term adverse outcomes for survivors of violent trauma. J Trauma Acute Care Surg. 2022 Mar 1;92(3):511-519. doi: 10.1097/TA.0000000000003364.

  PMID: 34284465 BACKGROUND

• Fein JA, Mollen CJ, Greene MB. The assault-injured youth and the emergency medical system: What can we do? Clinical Pediatric Emergency Medicine. 2013;14(1):47-55.

  BACKGROUND

• Liebschutz J, Schwartz S, Hoyte J, Conoscenti L, Christian AB Sr, Muhammad L, Harper D, James T. A chasm between injury and care: experiences of black male victims of violence. J Trauma. 2010 Dec;69(6):1372-8. doi: 10.1097/TA.0b013e3181e74fcf.

  PMID: 20838259 BACKGROUND

• Mathe N, Johnson ST, Wozniak LA, Majumdar SR, Johnson JA. Alternation as a form of allocation for quality improvement studies in primary healthcare settings: the on-off study design. Trials. 2015 Aug 25;16:375. doi: 10.1186/s13063-015-0904-x.

  PMID: 26303892 BACKGROUND

• Mikhail JN, Nemeth LS. Trauma Center Based Youth Violence Prevention Programs: An Integrative Review. Trauma Violence Abuse. 2016 Dec;17(5):500-519. doi: 10.1177/1524838015584373. Epub 2015 Jun 29.

  PMID: 26123004 BACKGROUND

Related Links

• firearm homicides data

MeSH Terms

Conditions

Adolescent Behavior

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Julia M Fleckman, PhD, MPH

  Tulane University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia M Fleckman, PHD, MPH

CONTACT

504-988-9937; jfleckma@tulane.edu

Timothy K Craft, MSW

CONTACT

tcraft@tulane.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: August 31, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 30, 2028
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)