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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06239285
Other study ID # HM20027823_Thomson
Secondary ID R01CE003625
Status Recruiting
Phase N/A
First received
Last updated
Start date February 26, 2024
Est. completion date October 2026

Study information

Verified date June 2024
Source Virginia Commonwealth University
Contact Nicholas Thomson
Phone (804) 297-5740
Email Nicholas.thomson@vcuhealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Brief Violence Intervention-Virtual Reality (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. This proposal will develop five steps to create a 30-minute brief firearm-related violence intervention. The five steps address a range of psychosocial risk factors and enhance protective factors for violence, as well as psychoeducational programming specifically addressing the risk of firearm violence. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 220
Est. completion date October 2026
Est. primary completion date September 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - violently injured patients from VCU's Level 1 Trauma Center - 18 years or older - English-speaking Exclusion Criteria: - Under 18 years old - Not a victim of Violent crime

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Brief Violence Intervention VR (BVI-VR)
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
Other:
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. 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.).

Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (2)

Lead Sponsor Collaborator
Virginia Commonwealth University Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 (a = .75) and good convergent and discriminant validity with other violence related measures Baseline self-report, 3- and 6-months post-randomization
Primary 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 (a = .79-.96). 3 and 6 month post baseline
Primary 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.
Primary 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 Firearm-related re-injury/ Self-report Violent injury data are collected from self-report surveys which capture the number of times a participant has been violently injured and what the patient was injured by (GSW). 3 and 6 month post baseline
Secondary Firearm-related re-injury/ Hospital data: Virginia Department of Health Violent injury data are collected from VCU's hospital database. 3 and 6 month post baseline
Secondary Firearm-related mortality/ Hospital data; Virginia Department of Health; National Death Index Mortality rates will be collected from hospital records and the National Death Index database. 3 and 6 month post baseline
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