- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07475247
A Hospital-based Intervention for Youth Injured Through Violence
March 11, 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
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
360
Phase
- 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
- Name: Terri Sulivan
- Phone Number: 804-828-9304
- Email: tnsulliv@vcu.edu
Study Contact Backup
- Name: Nicholas Thomson
- Phone Number: 804-628-5541
- Email: nthomson2@vcu.edu
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University
-
Contact:
- Nicholas Thomson
- Phone Number: 804-628-5541
- Email: nthomson2@vcu.edu
-
-
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
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: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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).
|
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.
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
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
Collaborators
Investigators
- 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 (Estimated)
April 1, 2026
Primary Completion (Estimated)
October 1, 2028
Study Completion (Estimated)
October 1, 2028
Study Registration Dates
First Submitted
March 11, 2026
First Submitted That Met QC Criteria
March 11, 2026
First Posted (Actual)
March 16, 2026
Study Record Updates
Last Update Posted (Actual)
March 16, 2026
Last Update Submitted That Met QC Criteria
March 11, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID 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.
Clinical Trials on Violence
-
Johns Hopkins UniversityNational Institute on Minority Health and Health Disparities (NIMHD)CompletedViolence, Domestic | Violence | Violence, Sexual | Violence, Physical | Violence, Gender-Based | Violence-Related SymptomUnited States
-
University of PittsburghCenters for Disease Control and PreventionRecruitingViolence, Domestic | Violence in Adolescence | Violence, Sexual | Violence, Physical | Violence, Non-accidental | Social Cohesion | Violence, Structural | Community ViolenceUnited States
-
Medical Research Council, South AfricaUniversity of GhanaUnknownSexual Violence | Domestic Violence | Physical ViolenceGhana
-
Karolinska InstitutetRegion Stockholm; Jane and Dan Olsson Foundation for Scientific PurposesCompletedDomestic Violence | Family Violence | Intimate-partner ViolenceSweden
-
London School of Hygiene and Tropical MedicineInternational Rescue Committee; National Institutes of Medical Research, Tanzania and other collaboratorsUnknownChild Abuse | Violence | Violence, Physical | Violence Against Children
-
University of PittsburghCenters for Disease Control and PreventionCompletedViolence, Domestic | Coping Skills | Violence in Adolescence | Adolescent Behavior | Violence, Sexual | Violence, Physical | Violence, Non-accidental | Group, Peer | Emotional Abuse | Communication, PersonalUnited States
-
University of PittsburghThe Grable Foundation; Department Human Services, Pennsylvania; Fisa FoundationCompletedViolence, Domestic | Coping Skills | Violence in Adolescence | Adolescent Behavior | Violence, Sexual | Violence, Physical | Violence, Non-accidental | Group, Peer | Emotional Abuse | Communication, PersonalUnited States
-
Johns Hopkins UniversityUniversity of Pittsburgh; Office of Research on Women's Health (ORWH); Futures...CompletedViolence, Domestic | Violence, SexualUnited States
-
Johns Hopkins Bloomberg School of Public HealthUjamaa AfricaCompletedViolence, Domestic | Violence, Sexual | Violence, Gender-BasedKenya
-
Kevin BorrupThe Tow FoundationRecruitingInterpersonal Violence | Structural ViolenceUnited States
Clinical Trials on Elevate Virtual Reality (VR)
-
National Institute of Mental Health, Czech RepublicCharles University, Czech Republic; Motol University HospitalCompletedLife Threatening Diseases | Pediatric Palliative Care | Life Limiting ConditionsCzechia
-
Filiz KeskinEnrolling by invitationPregnancy | Sleep Quality | Comfort | Nausea and Vomiting in Pregnancy (NVP)Turkey (Türkiye)
-
University Health Network, TorontoMichael Garron Hospital; Centre for Aging and Brain Health InnovationTerminatedDementia | Delirium Superimposed on DementiaCanada
-
University of MiamiEnrolling by invitation
-
University of California, Los AngelesCompleted
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityCompletedHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
University of California, Los AngelesRecruiting
-
Sultan Qaboos UniversityNot yet recruitingStroke Patients
-
Eastern Mediterranean UniversityCompleted
-
Mayo ClinicWithdrawnArrhythmiaUnited States