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Gun Violence PreventionSHIFTNCT06712940

Supportive Hospital-Based Intervention for Firearm Trauma

A study testing Motivational Interviewing and Firearm Safety Training, with Case Management in people with Gun Violence Prevention and Adolescent Behavior, run by Tulane University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 to 24 years
Conditions the study is for
Gun Violence Prevention, Adolescent Behavior
What is being tested?
Motivational Interviewing and Firearm Safety Training, with Case Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
1 siteUnited States
Study dates
31 Aug 2022to 30 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 24 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Julia M Fleckman, PHD, MPH contact

504-988-9937

jfleckma@tulane.edu

Timothy K Craft, MSW contact

tcraft@tulane.edu

United States1 site, 1 recruiting
  • Tulane School of Public Health and Tropical Medicine

    New Orleans, Louisiana, 70112

    Lexie M Contreras, MPH, lornelas@tulane.edu

    Julia M Fleckman, PhD

    Recruiting

Other trials in United States

About this study

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

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:

Read more
  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)
Read the detailed description

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:

  1. 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.
  2. 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.
  3. 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.
Being tested
Motivational Interviewing and Firearm Safety Training, with Case Management
Keywords
Firearm, Violence prevention, Youth
Medical subject headings
Adolescent Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational Interviewing and Firearm Safety Training, with Case ManagementBehavioural

    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.

Study groups in NCT06712940
Study groupRoleWhat they receive
Intervention ConditionExperimentalThe 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.
Receives: Behavioral: Motivational Interviewing and Firearm Safety Training, with Case Management
Treatment as UsualNo interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Firearm carriage

    Frequency of firearm carriage outside of home

    Measured: At time of enrollment

  2. Firearm storage

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

    Measured: At time of enrollment

  3. 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.

    Measured: At time of enrollment

  4. Firearm carriage

    Frequency of firearm carriage outside of home

    Measured: 3 months post-enrollment

  5. Firearm storage

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

    Measured: 3-months post enrollment

  6. 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.

    Measured: 3 months post-enrollment

  7. Firearm carriage

    Frequency of firearm carriage outside of home

    Measured: 6 months post-enrollment

  8. Firearm storage

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

    Measured: 6 months post-enrollment

  9. 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.

    Measured: 6 months post-enrollment

Secondary outcomes (2)
  1. Arrest records for gun violence

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

    Measured: 18 months post study activity completion

  2. Hospital readmittance for gun violence wounds

    Electronic medical record review to assess for firearm related reinjury

    Measured: 18 months post study activity completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2024
  2. Study start31 Aug 2022
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06712940
Sponsor's protocol ID
2021-1631-UMC
Other IDs
U01CE003384-01
Acronym
SHIFT
Status last verified
Feb 2025
First submitted
27 Nov 2024
Last updated
17 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IRB approval was not obtained to share IPD with other researchers.

Publications

  • 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.

  • 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.

    PubMed 26301734
  • 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.

    PubMed 23887566
  • 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.

    PubMed 34284465
  • 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.

  • 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.

    PubMed 20838259
  • 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.

    PubMed 26303892
  • 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.

    PubMed 26123004

Questions about this trial

What is this clinical trial studying?

A study testing Motivational Interviewing and Firearm Safety Training, with Case Management in people with Gun Violence Prevention and Adolescent Behavior, run by Tulane University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julia M Fleckman, PHD, MPH (504-988-9937, jfleckma@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Firearm carriage (time frame: At time of enrollment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06712940, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.

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