NCT07475247

Brief Summary

The firearm violence epidemic is a major public health problem, especially for youth. Every day in the US, approximately 100 people fall casualty to firearms through forms of violence, such as homicide, suicide, and unintentional or accidental injuries. Among youth, firearm violence remains the leading cause of death, and each year the rate of firearm-related mortality is increasing. Beyond the significant and devastating cost of human life, firearm violence is an enormous economic burden to the US, which totals an estimated $229 billion annually. In urban communities with high rates of firearm-related violence, firearm-related emergency department visits are extremely draining on the hospital system. At the national level, firearm-related injuries account for $2.8 billion annually in emergency department care each.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Apr 2026

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026Oct 2028

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

2.5 years

First QC Date

March 11, 2026

Last Update Submit

March 11, 2026

Conditions

Keywords

Virtual RealityFire-arm violence among youth

Outcome Measures

Primary Outcomes (7)

  • Firearm-related violence assessment

    The Gun Violence Questionnaire is a 4-item screening tool used primarily in healthcare settings to predict the risk of future firearm violence among youth and young adults. Individuals are classified into low-risk (0 points), medium-risk (1-5 points), or high-risk (≥ 6 points)

    Baseline, Follow-up at 1 and 3 months post baseline

  • Violent crime assessment

    Violent Crime Assessment is a process used by forensic, legal, and clinical professionals to estimate the likelihood, nature, and severity of future violent behavior. A 26-item tool that measures 6 static and 20 dynamic variables to assess both risk and potential for treatment change. Total scores typically range from -32 to +40; higher scores indicate a higher probability of re-offending.

    Baseline, Follow-up at 1 and 3 months post baseline

  • Firearm-related attitudes and beliefs assessment

    Firearm Aggression Questionnaire contains subscales for reactive violence (e.g., using a gun when provoked) and proactive violence (e.g., using a gun to take things from others). Items are rated on a 3-point scale (0 = never, 1 = sometimes, 2 = often), with higher total scores indicating a greater frequency of firearm violence.

    Baseline, Follow-up at 1 and 3 months post baseline

  • Firearm-related re-injury

    Number of injuries with and without hospitalization count. The lower the number is desired.

    Baseline, Follow-up at 1 and 3 months post baseline

  • Risky behaviors

    Youth Risk and Behavior Survey (YRBS) is a survey monitoring health-risk behaviors among U.S. high school students (grades 9-12). It tracks six main areas: injury/violence, sexual behaviors, substance use, diet, physical activity, and mental health. The Youth Risk Behavior Survey (YRBS) is not "scored" like a typical academic or clinical test where individuals receive a personal score. Instead, it is a surveillance tool used to calculate prevalence estimates (percentages) for specific health-risk behaviors across a population.

    Baseline, Follow-up at 1 and 3 months post baseline

  • Personality traits

    Behavior Assessment System for Children is a comprehensive, multi-method tool used by professionals (such as school psychologists and clinicians) to evaluate the individual behavioral and emotional status of children and young adults . BASC-3 results are reported as T-scores, which have a mean of 50 and a standard deviation of 10. The higher the score, the higher the risk.

    Baseline, Follow-up at 1 and 3 months post baseline

  • Future aspirations

    The Positive Outlook Survey used to measure a student's psychological well-being, resilience, and optimism. Likert scales (e.g., 1 to 5) used to calculate a total "positivity" or "optimism" score. The higher the score, the higher the optimism.

    Baseline, Follow-up at 1 and 3 months post baseline

Study Arms (2)

Youth

EXPERIMENTAL

Youth (aged 13-17 years) who received treatment in the hospital for an intentional or unintentional injury, or youth recruited from community partners and other referrals.

Other: Elevate Virtual Reality (VR)

Caregiver

EXPERIMENTAL

Caregivers of youth participants (18 years and older).

Other: Elevate Virtual Reality (VR)Other: Assessement completion

Interventions

Elevate VR is a brief violence intervention program founded on the principles of positive psychology, motivational goal setting (via gameplay), psychoeducation, cognitive-behavioral therapy, and dialectical behavioral therapy. Elevate VR includes five psychoeducational topic modules creating a 40-minute brief violence intervention. This duration is similar to well-established brief hospital-based violence interventions.

CaregiverYouth

Questionnaires will be administered to assess Firearm-related violence ( The Gun Violence Questionnaire), Violent crime (Violent Crime Assessment) and Firearm-related attitudes and beliefs (Firearm Aggression Questionnaire)

Caregiver

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 13-17 years old
  • English speaking

You may not qualify if:

  • Youth aged \<13 years and \>17 years old
  • Non-English speaking
  • Youth of caregivers younger than 18 years old
  • \- Aged 18 years or older
  • \- Aged younger than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Study Officials

  • Nicholas Thomson

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Terri Sulivan

CONTACT

Nicholas Thomson

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Youth (aged 13-17 years) who received treatment in the hospital for an intentional or unintentional injury, or youth recruited from community partners and other referrals; caregivers of youth participants (18 years and older). 180 youth-caregiver dyads (N=360)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations