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临床试验/NCT06712940
NCT06712940招募中不适用

Preventing Youth Firearm Violence in New Orleans: A Hospital-Initiated Community Integrated Approach

Tulane University1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2022年8月31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
350
试验地点
1
主要终点
Firearm carriage

研究概览

简要总结

This study is a quasi-experimental design, specifically a non-randomized controlled trial (NCT) designed to test the effects of gun violence reduction intervention including MI for youth ages 16-24 years old who present to the Emergency Department or ICU Spirit of Charity Trauma Center (SCTC) at University Medical Centers or another area hospital in New Orleans, Louisiana following a gunshot injury or stab wound. The study will utilize an enrollment strategy that involves alternating, across recruitment days, the assigned study condition. Thus, Day 1 participants would be enrolled into TAU, Day 2 participants would be enrolled in MI-case management condition, Day 3 participants would be enrolled in TAU, etc. This proposed design will minimize any confounds associated with self-selection while possibly increasing enrollment rate.

Research questions include:

  1. Will youth allocated to the MI prevention condition have safer firearm related behaviors and beliefs compared to the TAU control condition at 6 months post- enrollment?
  2. Will youth allocated to the MI prevention condition have reduced gun violence recidivism compared to the TAU control condition at 18 months post-enrollment.
  3. How do youth's social and normative environments influence their gun behaviors and attitudes?

Researchers will compare intervention and TAU arms to see if there are any differences in outcome measures.

Participants will:

  1. complete study eligibility assessment, be assigned to one of two conditions depending on the date of assessment, consent, and enroll in the Emergency Department (ED) or inpatient unit of hospital by a study team member,
  2. participate in one of two conditions: MI administered by a licensed clinical social worker, or treatment as usual control group (TAU) administered by a study team member (n=170 per condition)
  3. complete three surveys (baseline, 3-month, and 6-month) conducted by a study team member
  4. 18-month post examination of participant hospital records
  5. have the option to complete a 1-1.5 hour interview, 1-3 months after the 6-month survey is completed (n=50)

详细描述

The long-term goal of this study is to decrease community rates of youth gun violence. The objective is to test the long-term effects of a hospital-initiated intervention and examine how social contexts influence its adoption and sustained effects. This study will be conducted in collaboration with the Spirit of Charity Trauma Center at University Medical Center to implement a hospital-initiated intervention to reduce gun violence amongst older youth.

The multi-faceted intervention includes motivational interviewing and firearm safety training as part of a broader risk reduction effort involving case management. The proposed study, known as the Supportive Hospital-Based Intervention for Firearm Trauma (SHIFT), will employ a mixed methods approach, including a quasi-experimental study, to test the efficacy of the Motivational Interviewing (MI) intervention compared to treatment as usual (TAU) control condition. The hypothesis of this study is that this harm reduction intervention will be more effective in changing firearm-related behaviors and beliefs than the control condition at 3- and 6-months and reducing gun violence at 18-months post-baseline. If successful, the proposed intervention would significantly reduce gun violence and gun violence recidivism amongst youth in our community. The investigators will test our hypothesis via three specific aims:

  1. To establish the effects (at 6 months) of a hospital-initiated, community-integrated practice approach on firearm related behaviors and beliefs amongst older youth (16 to 24 years). Our primary working hypothesis is that youth allocated to the MI prevention condition will have safer firearm related behaviors and beliefs compared to the TAU control condition at 6 months post- enrollment.
  2. To establish the effects (at 18 months) of hospital-initiated, community-integrated practice- based approach on rates of gun violence amongst older youth (16 to 24 years). Our primary working hypothesis is that youth allocated to the MI prevention condition will have reduced gun violence recidivism compared to the TAU control condition at 18 months post-enrollment. Gun violence constructs to be measured include hospital readmittance for gun violence wounds, arrest records for gun violence, and frequency of carrying or using a gun.
  3. To gain in-depth understanding of older youth's (16 to 24 years) social and normative environments that may influence such a practice. Supplementing quantitative findings with a qualitative study of older youth will more fully capture the social contexts supporting or hindering gun violence behavior changes supported by our practice-based approach. Identifying and examining these factors in-depth will contribute to a more nuanced understanding of how to support the long-term durability of approach effects.

研究设计

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

入排标准

年龄范围
16 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •16 to 24 years old
  • •gunshot wound, stab wound, or assault related blunt force trauma injury treated at University Medical Center
  • •reside in the state of Louisiana
  • •capacity to provide voluntary informed consent or assent as approved by the Institutional Review Board of Tulane University

排除标准

  • •not voluntarily agreeing to participate
  • •not available to participate in study activities in a private room
  • •age under 16 or over 24
  • •do not reside in the state of Louisiana
  • •not acknowledging English as their first language
  • •being in the judgment of the trauma surgery service as too physically compromised to participate
  • •intellectual disability as estimated by clinician judgment following mental status examination
  • •current psychosis as evidenced by structured clinical interview and mental status examination that are administered on as needed basis
  • •current legal detention status
  • •injury was a result of intimate partner violence
  • •does not have the capacity to provide voluntary informed consent or assent as approved by the Institutional Review Board of Tulane University

研究组 & 干预措施

Intervention Condition

Experimental

The experimental arm condition consists of motivational interviewing with case management and firearm safety training with a licensed clinical social worker (LCSW). Motivational Interviewing (MI) is a participant-centered yet directive method for enhancing readiness to change. The purpose of MI is to help an individual articulate their own reasons and develop their own plans for making behavioral change. MI respects these values of self-determination and self-efficacy, and emphasizes the participant's right to make decisions about change. The firearm safety training (FST) will be led by the team's LCSW and include a brief demonstration, identification of reasons why the participant may or may not practice safe storage, and develop a plan moving forward. The FST will integrate MI techniques throughout the session.

干预措施: Motivational Interviewing and Firearm Safety Training, with Case Management (Behavioral)

Treatment as Usual

No Intervention

Patients assigned to the TAU condition will receive standard care for victims of violence at the Trauma Center. All TAU-assigned patients will be screened by psychiatry consult/liaison staff for posttraumatic symptoms, depression, and substance use. Patients with significant symptoms will be offered pharmacotherapy and/or supportive psychotherapy. Patients will also be provided with a list of community resources available for victims of violence, including mental health and social services.

Patients in TAU will receive the same information sheet (e.g., job training) provided to patients in the MI condition.

结局指标

主要结局

Firearm carriage

时间窗: 6 months post-enrollment

Frequency of firearm carriage outside of home

Firearm storage

时间窗: 6 months post-enrollment

Categorical description of firearm storage (locked and loaded, locked and unloaded, unlocked and loaded, unlocked and unloaded)

Firearm beliefs

时间窗: 6 months post-enrollment

Summary scale of firearm beliefs from a modified version of the Gun Beliefs and Behaviors Scale (GBBS). 7-point Likert scale will be used, and summed to create a composite score where a higher score indicates more positive firearm beliefs. The composite score range will be 0 to 21.

Firearm carriage

时间窗: At time of enrollment

Frequency of firearm carriage outside of home

Firearm storage

时间窗: At time of enrollment

Categorical description of firearm storage (locked and loaded, locked and unloaded, unlocked and loaded, unlocked and unloaded)

Firearm beliefs

时间窗: At time of enrollment

Summary scale of firearm beliefs from a modified version of the Gun Beliefs and Behaviors Scale (GBBS). 7-point Likert scale will be used, and summed to create a composite score where a higher score indicates more positive firearm beliefs. The composite score range will be 0 to 21.

Firearm carriage

时间窗: 3 months post-enrollment

Frequency of firearm carriage outside of home

Firearm storage

时间窗: 3-months post enrollment

Categorical description of firearm storage (locked and loaded, locked and unloaded, unlocked and loaded, unlocked and unloaded)

Firearm beliefs

时间窗: 3 months post-enrollment

Summary scale of firearm beliefs from a modified version of the Gun Beliefs and Behaviors Scale (GBBS). 7-point Likert scale will be used, and summed to create a composite score where a higher score indicates more positive firearm beliefs. The composite score range will be 0 to 21.

次要结局

  • Arrest records for gun violence(18 months post study activity completion)
  • Hospital readmittance for gun violence wounds(18 months post study activity completion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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