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临床试验/NCT04813185
NCT04813185招募中不适用

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

Virginia Commonwealth University1 个研究点 分布在 1 个国家目标入组 616 人开始时间: 2021年7月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
616
试验地点
1
主要终点
Firearm-related violence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • Non-English speaking
  • Prisoners

研究组 & 干预措施

Treatment as usual

No Intervention

Adults who will not receive BTG services and will receive treatment as usual (TAU) in the hospital.

In-hospital intervention

Experimental

Adults randomized to Bridging the Gap (BTG) services will receive a hospital-based violence prevention program with 6-months of community case management and a firearm counseling program.

干预措施: Bridging the Gap (Behavioral)

结局指标

主要结局

Firearm-related violence

时间窗: 12-months

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.

Firearm-related mortality

时间窗: 12-months

Collected from hospital records and National Death Index

Firearm-related re-injury

时间窗: 12-months

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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