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临床试验/NCT05568901
NCT05568901已完成不适用

Impact of Gun Lock Distribution on Firearm Securement After Emergent Mental Health Evaluation: A Randomized Controlled Trial

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年6月28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
200
试验地点
1
主要终点
Firearm securement

研究概览

简要总结

The goal of this clinical trial is to test the effect of providing gun locks to caregivers of children presenting to the emergency department for mental health concerns. The main question it aims to answer is:

• Does the provision of gun locks result in higher rates of securement of all household firearms? Participants will be randomized to receive either lethal means counseling (including summary handout) by study team with the provision of 2 cable-style gun locks or lethal means counseling by study team alone (without provision of gun locks).

Researchers will compare the lethal means counseling with 2 gun locks group to the lethal means counseling alone group to see if it affects self-reported securement of all household firearms, 4 weeks post emergency department encounter.

详细描述

Study Design and Population We conducted a single-center, prospective, randomized controlled trial with the emergency department of a free-standing tertiary care level-1 pediatric trauma center. Due to the nature of the study, investigators were not blinded to the interventions received by participants. This study was approved by the Cincinnati Children's Hospital Medical Center (CCHMC) Institutional Review Board. Study protocol, counseling handout, and surveys are available upon request to study team.

The study population consisted of firearm-owning caregivers of patients presenting to the PED for emergent MH evaluation. As only patients under the age of 18 can receive psychiatric care at our facility, all children of enrolled caregivers were less than 18 years of age.

Survey Development Survey content was derived from the expert opinion of PED physicians, injury prevention researchers, and psychiatry staff involved in the care of MH patients. Pre-counseling surveys contained questions regarding caregiver demographics as well as firearm and medication storage practices. Follow-up surveys repeated questions about storage behaviors with additional questions regarding how participants viewed PED-based counseling, use of the provided locks, removal of lethal means from the home, and the purchase of additional safety devices after PED encounter.

Counseling handouts and surveys were piloted for readability and content among 12 firearm-owning caregivers.17 Inclusion criteria revised to include all gun-owning caregivers rather than only those with unsafely stored weapons. Potential participants felt more comfortable relaying storage practices via anonymous survey as opposed to face-to-face with counselor during screening process. Content regarding another lethal mean, medication, was added to reduce perceived judgement surrounding firearm ownership.

Study Procedure All enrollment occurred within the primary PED of CCHMC between June 28, 2021 and February 10, 2022. Potential participants were identified by documented chief complaint of "Psychiatric Evaluation", which includes, but is not limited to, those presenting for: suicidal ideation/attempt, homicidal ideation/attempt, aggression, behavior change, and hallucinations. The Psychiatric Intake and Response Center (PIRC) team is made up of social workers and an attending psychiatrist that consult on all patients presenting to the PED for psychiatric evaluation. Caregivers who met inclusion criteria and received consultation by PIRC team were considered for enrollment. A convenience sample of caregivers were screened for enrollment by the study principal investigator (PI) or Clinical Research Coordinators (CRCs) specifically trained in study recruitment and lethal means counseling. CRCs were present in the PED 8am to 12pm on weekdays and 11am to 9pm on weekends. The PI aided in recruitment, as needed during high patient volumes.

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 (Participant)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Caregiver of pediatric patient presenting to the emergency department for mental health evaluation
  • •Caregiver endorses firearms within the home

排除标准

  • •Caregiver not present
  • •Caregiver is not able to complete survey in written English
  • •Caregiver unable to be approached due to unsafe conditions as determined by study team and behavioral safety specialists

研究组 & 干预措施

LMC Alone

Active Comparator

Caregivers who received standardized lethal means counseling (LMC) from the study team as well as a 1-page handout summarizing the counseling recommendations

干预措施: Lethal means counseling (Behavioral)

LMC + Gun Locks

Experimental

Caregivers who received standardized lethal means counseling (LMC) from the study team, 1-page handout summarizing the counseling recommendations, as well as the additional provision of 2 cable-style gun locks

干预措施: Lethal means counseling (Behavioral)

LMC + Gun Locks

Experimental

Caregivers who received standardized lethal means counseling (LMC) from the study team, 1-page handout summarizing the counseling recommendations, as well as the additional provision of 2 cable-style gun locks

干预措施: Provision of Cable-style gun locks (Behavioral)

结局指标

主要结局

Firearm securement

时间窗: 4 weeks post-encounter

Self-reported securement of all household firearms with locking device

次要结局

  • Use of locks(4 weeks post-encounter)
  • Change in firearm securement(4 weeks)
  • Change in medication securement(4 weeks)
  • Caregiver favorability(4 weeks post-encounter)
  • Medication securement(4 weeks post-encounter)
  • Firearm removal(4 weeks post-encounter)
  • Medication removal(4 weeks post-encounter)
  • Additional devices(4 weeks post-encounter)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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