A Hospital-based Intervention for Youth Injured Through Violence

June 30, 2026 updated by: Virginia Commonwealth University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In the state of Virginia, the rates of firearm-related fatalities are over seven times higher than the national rates, and the pandemic has made this worse, as we have seen a 52% increase in firearm-related hospitalizations. With the surge in firearm violence seen nationwide, there is a dire need for new, innovative, and effective interventions for preventing firearm-related violence, injury, and mortality among youth. Hospital-based brief violence interventions can result in long-term improvement. There is a plethora of research supporting that brief violence interventions can result in long-term improvements, including interventions for violence. Less is known about the extent to which they are effective for reducing firearm-related violence. Hospital-based brief violence interventions save lives and money. Most of the people who are violently injured are indigent and without health insurance. Inpatient costs for injury at VCU Trauma Center ranging from $33,000 to $300,000 per youth, and a national cost of violence estimated at $21 billion annually. The goal of this project is to evaluate Elevate VR an effective and innovative virtual reality (VR) brief violence intervention to prevent firearm-related violence, injury, and mortality among youth.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Youth participant inclusion criteria:

  • Aged 13-17 years old
  • English speaking

Youth participant exclusion criteria:

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

Adult/caregiver participant inclusion criteria:

- Aged 18 years or older

Adult/caregiver participant exclusion criteria:

- Aged younger than 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Youth
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)
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.
Experimental: Caregiver
Caregivers of youth participants (18 years and older).
Other: Elevate Virtual Reality (VR)
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.
Other: Assessement completion
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Firearm-related violence assessment
Time Frame: Baseline, Follow-up at 1 and 3 months post baseline
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
Time Frame: Baseline, Follow-up at 1 and 3 months post baseline
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
Time Frame: Baseline, Follow-up at 1 and 3 months post baseline
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
Time Frame: Baseline, Follow-up at 1 and 3 months post baseline
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
Time Frame: Baseline, Follow-up at 1 and 3 months post baseline
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
Time Frame: Baseline, Follow-up at 1 and 3 months post baseline
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
Time Frame: Baseline, Follow-up at 1 and 3 months post baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicholas Thomson, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HM20029563
  • R01HD112416 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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