Preventing Retaliatory Gun Violence in Violently Injured Adults

Violence Clinical Trial

Official title:

Preventing Retaliatory Gun Violence in Violently Injured Adults: A RCT of a Hospital-Based Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04813185
• Other study ID #: HM20020621
• Secondary ID: R01CE003296
• Status: Recruiting
• Phase: N/A
• Start date: July 27, 2021
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: Virginia Commonwealth University
• Contact: Nicholas Thomson
• Phone: 804-628-5541
• Email: Nicholas.Thomson[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to find out if a hospital-based violence intervention (Bridging the Gap) is effective for reducing violence. The researchers think that adults who receive Bridging the Gap will see greater improvements than those who do not receive the intervention. This study will allow them to learn more about the intervention's effectiveness. The study will also help them understand if the violence intervention affects other behaviors, such as firearm use, drug use, aggression, risky behaviors, and rates of violent re-injury.

Description:

Approximately 616 patients will enroll in this study. Participants will be asked to complete sessions about behavior, personality, and experiences. Participants will be randomized into a study group (either Bridging the Gap or Treatment as Usual) by drawing a number. If patients agree to the study but do not like the group they are assigned to, they can request to switch groups. Participants assigned to the Treatment as Usual intervention will receive a brief violence awareness brochure during your hospital stay. Participants assigned to the Bridging the Gap intervention will receive an in-hospital intervention and, once released from the hospital, will receive 6-months of community case management services. The study team thinks that adults who receive the Bridging the Gap intervention will see greater improvements than adults who do not receive the intervention. This study will allow them to learn more about the intervention's effectiveness.

During these study sessions participants will complete questionnaires about exposure to traumatic events, symptoms of trauma, history of suicide, aggression and violence, antisocial personality traits, illegal behaviors, substance use, and mental health. Participants will complete several tasks which measure cognitive ability, such as problem-solving, attention/concentration, and decision-making. They will also complete a clinical interview that covers antisocial personality traits and behaviors, including history of aggressive behavior and substance use. These interviews will be video recorded. These recordings will be used to help score the interviews and for training purposes. Information will also be collected from participant's medical records, including demographic information, history and reason for past hospitalizations, mental health history, and substance use reports, as well as a criminal background check.

The surveys take about 2 hours to complete. Participants will complete these questionnaires again 6 and 12 months later. Participation in this study will last up to 12 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 616
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• They receive treatment in the hospital for a violence-related injury (e.g., gunshot wound)

• They are 18 years or older

• They are English speaking

• They are eligible for BTG services (which includes living within the BTG catchment area for the hospital; Richmond City and neighboring counties)

Exclusion Criteria:

• Non-English speaking

• Age <18

• Prisoners

Related Conditions & MeSH terms

• Violence

Intervention

Behavioral:
• Bridging the Gap
Bridging the Gap Bridging the Gap is a hybrid model for violence prevention which integrates a hospital-based brief violence intervention (BVI) delivered to the patient while in hospital with a wrap-around community case management prevention strategy. Firearm Counseling Program The firearm counseling program was developed to be administered in the hospital alongside the 6-step intervention program, as well as in the patient's home after hospital discharge. The firearm safety counseling program includes 3 components aimed at understanding patient risk, reducing firearm-related violence risk-factors, and helping patients increase firearm safety practices.

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	Number of firearm-related violence incidents will be measured multiple ways including self-report and a semi-structured clinical assessment of non-convicted firearm-related violence. Incidents will be summed to yield a single count of unique firearm-related violence incidents for each participant.	12-months
Primary	Firearm-related re-injury	Number of firearm-related re-injury incidents will be measured multiple ways including self-report and hospital records. Incidents will be summed to yield a single count of unique firearm-related re-injuries for each participant.	12-months
Primary	Firearm-related mortality	Collected from hospital records and National Death Index	12-months