Clinical trial NCT03835585: Gun Locks in Firearm Suicide Intervention
Official title: The Provision of Gun Locks in Lethal Means Counseling to Increase Firearm Safety in a Suicide Risk Sample
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group and comparison group measured immediately prior to intervention, immediately after intervention, 2 weeks after intervention, and one month after intervention. Analyses conducted will be Repeated Measures Analysis of Variance (RM-ANOVA).
Primary purpose: PREVENTION

Brief summary: This study compares the effectiveness of two interventions for suicide over the course of a month. The experimental intervention includes the provision of a gun lock with video instructions, in addition to standard suicide risk interventions (i.e., standardized full suicide risk assessment, safety planning, and lethal means counseling). The comparison intervention group will receive the same standard suicide risk interventions without the gun lock and video. The targeted outcome will be level of engagement in gun safety behaviors (e.g., using a gun lock, using a gun safe, considering getting rid of guns). It is predicted that the experimental intervention will result in greater increases over time in engagement in gun safety behaviors, as compared to the comparison intervention.

Detailed description: Purpose: While psychology research and the suicide literature have not provided this evidence in a manner relevant to lethal means counseling, research across various disciplines has clearly demonstrated that providing individuals with gun locks and knowledgeable information about their proper use will significantly increase the likelihood that individuals will engage in firearm safety behaviors. The present study seeks to examine if the provision of gun locks, in addition to the current best standard interventions for suicide risk according to research, will significantly increase engagement in these behavioral outcomes.

Research Design/Method: The present study will utilize an experimental design with two groups, an experimental intervention group and a comparison intervention group. The experimental intervention group will receive the highest standard interventions (i.e., standardized full suicide risk assessment, safety planning, and lethal means counseling) in addition to a gun lock and instructional video. The comparison intervention group will receive the highest standard interventions, but will not be provided gun locks until after the study is complete.

The gun locks will be 15-inch cable locks. Locks will be mailed via USPS in envelopes upon completion of screener, if eligible for the study, but before they are scheduled to complete the first portion of the study. this will be arranged by making scheduling calls for initial sessions the day of/day after (depending on time) screeners are completed, scheduling initial sessions at least a week and a half after scheduling calls, and mailing the locks the day of scheduling calls.

Gun locks will be mailed to participants in the experimental intervention group. Data will be collected over three sessions. The first will be when baseline measures (e.g., demographics, outcomes) will be administered online, the intervention will be provided for all individuals by phone and online(only for the video instructions for lock), and post-intervention measures of outcome variables will assessed online. The 2-week follow-up interval and the 1-month interval will involve only assessment of the outcomes online. Participants in comparison intervention group will be provided gun locks after participation in the study is complete.

Research Question: Will the experimental intervention group outperform the comparison intervention group, regarding effectiveness in increasing engagement in firearm safety behaviors?

Hypothesis: The intervention for the experimental intervention group will be significantly more effective at increasing engagement in firearm safety behavior than that which will be provided for the comparison intervention group.

Data Analysis: Repeated Measures Analysis of Variance (RM-ANOVA) will be conducted, with a focus on measuring the interaction effects of Group and Time to assess whether experimental intervention group was significantly more effective than the comparison intervention group.

Eligibility criteria: Inclusion Criteria:

* Must own and have access to a firearm
* Must have at least one lifetime episode of suicide ideation
* Must be 18 years of age or older

Exclusion Criteria:

- May not be under 18 years of age

Primary outcomes:
measure: Engagement in Firearm Safety Behaviors
timeFrame: Immediately prior to intervention
measure: Engagement in Firearm Safety Behaviors
timeFrame: Two weeks after intervention
measure: Engagement in Firearm Safety Behaviors
timeFrame: One month after intervention
Secondary outcomes:
measure: Intentions to Adhere to Clinician Recommendations
timeFrame: Immediately prior to Intervention
measure: Intentions to Adhere to Clinician Recommendations
timeFrame: Immediately after intervention
measure: Intentions to Adhere to Clinician Recommendations
timeFrame: Two weeks after intervention
measure: Intentions to Adhere to Clinician Recommendations
timeFrame: One month after intervention
measure: Acceptability of Intervention
timeFrame: Immediately prior to intervention
measure: Acceptability of Intervention
timeFrame: Immediately after intervention
measure: Acceptability of Intervention
timeFrame: Two weeks after intervention
measure: Acceptability of Intervention
timeFrame: One month after intervention
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Robert O. Lawton Distinguished Professor
name: Thomas E Joiner, PhD
role: STUDY_DIRECTOR
affiliation: Graduate Student
name: Bruno Chiurliza, MS
role: PRINCIPAL_INVESTIGATOR
References: