NCT06239285

Brief Summary

The overall aim of the proposed project is to develop and evaluate the effectiveness of Brief Violence Intervention-Virtual Reality (BVI-VR) for reducing firearm-related violence, re-injury, and mortality among victims of violence. Outcome measures of firearm-related violence will come from multiple sources, including criminal background checks, hospital data, state-level data, semi-structured clinical assessments, and self-report assessments. In addition, the study aims to understand the impact of BVI-VR on psychosocial mediators resulting in a reduction of firearm-related violence. This will include self-report surveys, neurocognitive assessments, and clinical assessments. The economic efficiency of BVI-VR as a firearm-related violence intervention will also evaluated. To achieve these aims, a randomized control trial (RCT) in a large sample of violently injured adults (18+ years) from VCU Health will be conducted.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Feb 2024Oct 2026

First Submitted

Initial submission to the registry

January 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

February 26, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

2.5 years

First QC Date

January 26, 2024

Last Update Submit

June 6, 2025

Conditions

Keywords

Firearm Violence Victim

Outcome Measures

Primary Outcomes (4)

  • Firearm-related violence /The gun violence questionnaire

    The gun violence questionnaire is a 9-item self-report that assesses firearm-related violence. Items were adapted from the Buss-Perry Aggression Questionnaire physical aggression scale; for example, "Given enough provocation, I may fire my gun at another person". The measure has adequate internal consistency (α = .75) and good convergent and discriminant validity with other violence related measures

    Baseline self-report, 3- and 6-months post-randomization

  • Gun Behaviors and Beliefs Scale

    Gun Behaviors and Beliefs Scale will be used to measure gun behaviors and beliefs that may be impacted by the intervention: Safety and Control, Social Perceptions, Emotional Risk, Common Beliefs. The subscales have demonstrated adequate to good internal consistency (α = .79-.96).

    3 and 6 month post baseline

  • Firearm criminal conviction and arrests/ Criminal Background Checks

    Criminal background checks will be conducted on participants to assess violent criminal arrests and gun-related crimes and police contacts. Criminal activity will be coded for the occurrence of nonviolent crime, violent crime, and firearm-related crime for three-time points: prior to baseline assessment, from baseline to 3-month follow-up, and from 3-month follow-up to the 6-month follow-up.

    prior to baseline assessment, from baseline to 3-month follow-up, and from 3-month follow-up to the 6-month follow-up.

  • Non-convicted firearm-related violent crime/ Violent Crime Assessment

    Violent Crime Assessment is a semi-structured clinical assessment of convicted and non-convicted violent crime. The measure captures six categories of violent crimes that participants have and have not been arrested for; simple assault, aggravated assault, homicide, robbery, rape, and sexual assault. Information is collected on weapon use for each of the crimes (e.g., used a firearm during rape; fired a gun at a party and may have hit someone). The VCA provides a valuable index for firearm-related violence that is not captured in self-report measures or criminal background checks.

    3 and 6 month post baseline

Secondary Outcomes (3)

  • Firearm-related re-injury/ Self-report

    3 and 6 month post baseline

  • Firearm-related re-injury/ Hospital data: Virginia Department of Health

    3 and 6 month post baseline

  • Firearm-related mortality/ Hospital data; Virginia Department of Health; National Death Index

    3 and 6 month post baseline

Study Arms (2)

Treatment as Usual (TAU) Group

PLACEBO COMPARATOR

The treatment-as-usual (TAU) group will receive a community resource brochure (the same one that is provided at the end of BVI-VR). This brochure provides contact detail for services in the local area.

Other: Treatment as Usual (TAU)

Intervention Group

EXPERIMENTAL

Patients randomized into the BVI-VR group will answer questions about the session content and the rationale for the content. Their responses will provide an estimate of engagement providing a better understanding of treatment fidelity.

Device: Brief Violence Intervention VR (BVI-VR)

Interventions

BVI-VR is being developed as a hospital-based brief gun violence intervention program founded on the principles of positive psychology, motivational goal setting (via gameplay), psychoeducation, cognitive-behavioral therapy, and dialectical behavioral therapy. All steps of the BVI-VR emphasize being in control of making positive choices, and how to locate and leverage opportunities within their communities to improve their well-being. BVI-VR empowers patients to be the driver of their well-being

Intervention Group

group will receive a community resource brochure (the same one that is provided at the end of BVI-VR). This brochure provides contact detail for services in the local area. These include organizations that provide mental health counseling, mentorship services, career development programs, organized community activities and sports, educational support, financial support, substance abuse programs, and resource assistance (e.g., food, housing, etc.).

Treatment as Usual (TAU) Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • violently injured patients from VCU's Level 1 Trauma Center
  • years or older
  • English-speaking

You may not qualify if:

  • Under 18 years old
  • Not a victim of Violent crime

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 232398, United States

RECRUITING

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Nicholas Thomson

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized control trial (RCT) in a large sample of violently injured adults (18+ years) from VCU Health.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2024

First Posted

February 2, 2024

Study Start

February 26, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

June 8, 2025

Record last verified: 2025-06

Locations