ViolenceNCT07475247
A Hospital-based Intervention for Youth Injured Through Violence
A study testing Elevate Virtual Reality (VR) and Assessement completion in people with Violence, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Violence
- What is being tested?
- Elevate Virtual Reality (VR) and Assessement completion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to Oct 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Nicholas Thomson, 804-628-5541, nthomson2@vcu.edu
About this study
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.
Read the 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.
- Conditions
- Violence
- Being tested
- Elevate Virtual Reality (VR), Assessement completion
- Keywords
- Virtual Reality, Fire-arm violence among youth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elevate Virtual Reality (VR)Other
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.
Assessement completionOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Elevate Virtual Reality (VR) |
| Caregiver | Experimental | Caregivers of youth participants (18 years and older). Receives: Other: Elevate Virtual Reality (VR); Other: Assessement completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Follow-up at 1 and 3 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Apr 2026
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ViolenceStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Nicholas Thomson, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475247
- Sponsor's protocol ID
- HM20029563
- Other IDs
- R01HD112416
- Status last verified
- Jun 2026
- First submitted
- 11 Mar 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hospital-based Intervention for Youth Injured Through Violence
- ClinicalTrials.gov ID
- NCT07475247
- Acronym / sponsor ID
- HM20029563
- Conditions
- Violence
- Keywords
- Virtual Reality, Fire-arm violence among youth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Youth | Experimental | Other: Elevate Virtual Reality (VR)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. |
| Caregiver | Experimental | Other: Elevate Virtual Reality (VR), Other: Assessement completionCaregivers of youth participants (18 years and older). |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Caregiver, Youth |
| Assessement completionQuestionnaires 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) | Other | Caregiver |
Primary outcome
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)
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas Thomson principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elevate Virtual Reality (VR) and Assessement completion in people with Violence, run by Virginia Commonwealth 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?
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 2 Jul 2026. 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 Nicholas Thomson (804-628-5541, nthomson2@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Firearm-related violence assessment (time frame: Baseline, Follow-up at 1 and 3 months post baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2026.