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临床试验/NCT05109325
NCT05109325已完成不适用

IntERact: Preventing Risky Firearm Behaviors Among Urban Youth Seeking Emergency Department Care

University of Michigan6 个研究点 分布在 1 个国家目标入组 373 人开始时间: 2022年1月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
373
试验地点
6
主要终点
Change in Risky Firearm Behaviors

研究概览

简要总结

The present study is evaluating the efficacy of a behavioral intervention to reduce risky firearm carriage among a high risk sample of youth reporting recent firearm carriage and ownership of a smartphone.

详细描述

Firearms are the leading cause of death for U.S. youth; 60% due to homicide. This study will test the efficacy of a behavioral intervention at reducing risky firearm behaviors among a high-risk community sample of youth (age 16-24) that report past 3-month firearm carriage and smartphone ownership. The behavioral intervention consists of 3 remotely delivered therapy sessions integrating motivational interviewing (MI), cognitive behavioral therapy (CBT), and care management (CM), supported by a smartphone APP that facilitates therapist contact, conducts automated daily assessments, delivers between session tailored therapy content, delivers just-in-time Global Positioning System (GPS)-triggered notifications upon entry into high-risk locations, and aids with utilization of local resources. Recruitment will proceed in two high-risk communities (Flint, Saginaw), including through the main Emergency Departments/trauma centers that are located in both cities. Given elevated rates of firearm violence among socio-disadvantaged youth with disparities in access to community services, the proposed intervention, if found to be efficacious, has the potential for significant public health impact.

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
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Flint or Saginaw Youth between the ages of 16 to 30 reporting past 3-month firearm carriage and ownership of a smartphone, including those seeking care for any reason at Hurley Medical Center or Covenant Medical Center Emergency Department.
  • Can provide consent (age: 18-30) or youth assent and parental consent (age: 16-17) for the study.

排除标准

  • Incarcerated (i.e., in active policy custody and not able to provide informed consent)
  • Presenting to the ED for active suicide ideation or attempt, sexual assault, and/or child abuse
  • Unable to provide informed consent due to mental status (e.g., alcohol intoxication, acute psychosis) or medical instability.
  • Participants will be excluded if firearm carriage is exclusively for legal work (e.g., police), hunting, or target shooting.

研究组 & 干预措施

Enhanced usual care + assessment

No Intervention

Daily assessments (without delivery of intervention components) will be conducted with EUC participants and they will receive a brochure with violence, substance use, and mental health resources.

IntERact

Experimental

Participants will receive three remotely delivered behavioral therapy sessions (combining motivational interviewing, cognitive behavioral skills training, and care management), with an smartphone APP supporting the therapy and delivering therapeutic content in-between therapy sessions.

干预措施: IntERact (Behavioral)

结局指标

主要结局

Change in Risky Firearm Behaviors

时间窗: Baseline to 3 months and 6 months

Composite measure used in prior work (Carter 2019). Composite measure uses items from the Tulane University Youth Study and Conflict Tactics Scale capturing frequency and severity of risky firearm-related behaviors (e.g. carriage, threats, use, etc.). (0=Never; 6=20+ Times)

Change in Risky Firearm Behaviors

时间窗: Baseline to 3 months and 6 months

Composite measure used in prior work (Carter 2019). Composite measure uses items from the Tulane University Youth Study and Conflict Tactics Scale capturing frequency and severity of risky firearm-related behaviors (e.g. carriage, threats, use, etc.). (0=Never; 6=20+ Times)

次要结局

  • Change in Aggression(Baseline to 3 months and 6 months)
  • Change in Victimization(Baseline to 3 months and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patrick Carter

Associate Professor of Emergency Medicine; Center Director, OVPR Institute of Firearm Research

University of Michigan

研究点 (6)

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