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NCT Number: NCT06712940

Supportive Hospital-Based Intervention for Firearm Trauma

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)

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Key information

Age range

16 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tulane School of Public Health and Tropical Medicine

New Orleans, Louisiana, 70112, United States

Location status: Recruiting

Location contact

Julia M Fleckman, PhD

PRINCIPAL_INVESTIGATOR

Lexie M Contreras, MPH

CONTACT

[email protected]

About this study

The long-term goal of this study is to decrease community rates of youth gun violence. The objective is to test the long-term effects of a hospital-initiated intervention and examine how social contexts influence its adoption and sustained effects. This study will be conducted in collaboration with the Spirit of Charity Trauma Center at University Medical Center to implement a hospital-initiated intervention to reduce gun violence amongst older youth.

The multi-faceted intervention includes motivational interviewing and firearm safety training as part of a broader risk reduction effort involving case management. The proposed study, known as the Supportive Hospital-Based Intervention for Firearm Trauma (SHIFT), will employ a mixed methods approach, including a quasi-experimental study, to test the efficacy of the Motivational Interviewing (MI) intervention compared to treatment as usual (TAU) control condition. The hypothesis of this study is that this harm reduction intervention will be more effective in changing firearm-related behaviors and beliefs than the control condition at 3- and 6-months and reducing gun violence at 18-months post-baseline. If successful, the proposed intervention would significantly reduce gun violence and gun violence recidivism amongst youth in our community. The investigators will test our hypothesis via three specific aims:

  • To establish the effects (at 6 months) of a hospital-initiated, community-integrated practice approach on firearm related behaviors and beliefs amongst older youth (16 to 24 years). Our primary working hypothesis is that youth allocated to the MI prevention condition will have safer firearm related behaviors and beliefs compared to the TAU control condition at 6 months post- enrollment.
  • To establish the effects (at 18 months) of hospital-initiated, community-integrated practice- based approach on rates of gun violence amongst older youth (16 to 24 years). Our primary working hypothesis is that youth allocated to the MI prevention condition will have reduced gun violence recidivism compared to the TAU control condition at 18 months post-enrollment. Gun violence constructs to be measured include hospital readmittance for gun violence wounds, arrest records for gun violence, and frequency of carrying or using a gun.
  • To gain in-depth understanding of older youth's (16 to 24 years) social and normative environments that may influence such a practice. Supplementing quantitative findings with a qualitative study of older youth will more fully capture the social contexts supporting or hindering gun violence behavior changes supported by our practice-based approach. Identifying and examining these factors in-depth will contribute to a more nuanced understanding of how to support the long-term durability of approach effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Firearm carriage

    Time frame: At time of enrollment

    Frequency of firearm carriage outside of home

  2. Firearm storage

    Time frame: At time of enrollment

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

  3. Firearm beliefs

    Time frame: At time of enrollment

    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.

  4. Firearm carriage

    Time frame: 3 months post-enrollment

    Frequency of firearm carriage outside of home

  5. Firearm storage

    Time frame: 3-months post enrollment

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

  6. Firearm beliefs

    Time frame: 3 months post-enrollment

    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.

  7. Firearm carriage

    Time frame: 6 months post-enrollment

    Frequency of firearm carriage outside of home

  8. Firearm storage

    Time frame: 6 months post-enrollment

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

  9. Firearm beliefs

    Time frame: 6 months post-enrollment

    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.

Secondary outcomes

  1. Arrest records for gun violence

    Time frame: 18 months post study activity completion

    Number of arrests that an individual experiences from time of study activity completion to 18-months post study activity completion

  2. Hospital readmittance for gun violence wounds

    Time frame: 18 months post study activity completion

    Electronic medical record review to assess for firearm related reinjury

Study contacts

Contact information is provided by the study sponsor or research team.

Julia M Fleckman, PHD, MPH

CONTACT

[email protected]

504-988-9937

Timothy K Craft, MSW

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Preventing Youth Firearm Violence in New Orleans: A Hospital-Initiated Community Integrated Approach

Acronym: SHIFT

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Dec 3, 2024
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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