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Ondersteunende ziekenhuisinterventie voor vuurwapentrauma (SHIFT)

3 november 2026 bijgewerkt door: Tulane University

Preventie van vuurwapengeweld onder jongeren in New Orleans: een door ziekenhuizen geïnitieerde geïntegreerde gemeenschapsaanpak

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)

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

48

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Louisiana
      • New Orleans, Louisiana, Verenigde Staten, 70112
        • Tulane School of Public Health and Tropical Medicine

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

16 jaar tot 24 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.

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.

Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Firearm carriage
Tijdsspanne: At time of enrollment

Frequency of firearm carriage outside of home

At time of enrollment
Firearm storage
Tijdsspanne: At time of enrollment

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

At time of enrollment
Firearm beliefs
Tijdsspanne: 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.

At time of enrollment
Firearm carriage
Tijdsspanne: 3 months post-enrollment

Frequency of firearm carriage outside of home

3 months post-enrollment
Firearm storage
Tijdsspanne: 3-months post enrollment

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

3-months post enrollment
Firearm beliefs
Tijdsspanne: 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.

3 months post-enrollment
Firearm carriage
Tijdsspanne: 6 months post-enrollment

Frequency of firearm carriage outside of home

6 months post-enrollment
Firearm storage
Tijdsspanne: 6 months post-enrollment

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

6 months post-enrollment
Firearm beliefs
Tijdsspanne: 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.

6 months post-enrollment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Arrest records for gun violence
Tijdsspanne: 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

18 months post study activity completion
Hospital readmittance for gun violence wounds
Tijdsspanne: 18 months post study activity completion

Electronic medical record review to assess for firearm related reinjury

18 months post study activity completion

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Julia M Fleckman, PhD, MPH, Tulane University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

31 augustus 2022

Primaire voltooiing (Werkelijk)

30 december 2025

Studie voltooiing (Geschat)

30 januari 2027

Studieregistratiedata

Eerst ingediend

27 november 2024

Eerst ingediend dat voldeed aan de QC-criteria

27 november 2024

Eerst geplaatst (Werkelijk)

3 december 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 november 2026

Laatste update ingediend die voldeed aan QC-criteria

3 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 2021-1631-UMC
  • U01CE003384-01 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

IRB approval was not obtained to share IPD with other researchers.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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