Gun Locks in Firearm Suicide Intervention
Primary Purpose
Suicide
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gun lock
Suicide Risk Assessment
Safety Planning
Lethal Means Counseling
Sponsored by
About this trial
This is an interventional prevention trial for Suicide
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
Sites / Locations
- Florida State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Gun lock
Standard intervention
Arm Description
Participants will be provided a gun lock and video instructions for its proper use, in addition to standard suicide risk interventions (i.e., standardized full suicide risk assessment, safety planning, lethal means counseling).
Participants will be provided standard suicide risk interventions (i.e., standardized full suicide risk assessment, safety planning, lethal means counseling) without a gun lock. A gun lock and video instructions will be provided upon completion of the study.
Outcomes
Primary Outcome Measures
Engagement in Firearm Safety Behaviors
This includes a variety of actions and thinking patterns that promote safety regarding firearms. This is measured by a self-report instrument (Engagement in Firearm Safety Behaviors; Stanley, 2018), which contains 34 items. The items are scored on a Likert scale (i.e., 0 = Never; 1 = Sometimes, 2 = Often, 3 = Always) to gauge frequency of engagement. 16 items represent behaviors (e.g., "using a gun lock," "trading in your guns") and 18 represent thoughts (e.g., "thought about obtaining a gun lock," "thought about storing your gun unloaded.")
Engagement in Firearm Safety Behaviors
This includes a variety of actions and thinking patterns that promote safety regarding firearms. This is measured by a self-report instrument (Engagement in Firearm Safety Behaviors; Stanley, 2018), which contains 34 items. The items are scored on a Likert scale (i.e., 0 = Never; 1 = Sometimes, 2 = Often, 3 = Always) to gauge frequency of engagement. 16 items represent behaviors (e.g., "using a gun lock," "trading in your guns") and 18 represent thoughts (e.g., "thought about obtaining a gun lock," "thought about storing your gun unloaded.")
Engagement in Firearm Safety Behaviors
This includes a variety of actions and thinking patterns that promote safety regarding firearms. This is measured by a self-report instrument (Engagement in Firearm Safety Behaviors; Stanley, 2018), which contains 34 items. The items are scored on a Likert scale (i.e., 0 = Never; 1 = Sometimes, 2 = Often, 3 = Always) to gauge frequency of engagement. 16 items represent behaviors (e.g., "using a gun lock," "trading in your guns") and 18 represent thoughts (e.g., "thought about obtaining a gun lock," "thought about storing your gun unloaded.")
Secondary Outcome Measures
Intentions to Adhere to Clinician Recommendations
A structured self-report questionnaire utilized in previous research (Stanley et al., 2017; Stanley, 2018) will be used in the present study to assess participants' intentions to adhere to clinician recommendations to limit access to a firearm for safety purposes. The two items will be rated on a 10-point Likert type scale (1 = Not At All Likely; 10 = Very Likely) and they will read as follows: 1) "How likely would you be to adhere to your clinician's recommendations to limit your access to a firearm for safety purposes?"; and 2) "How likely would you be to encourage a loved one to adhere to your clinician's recommendations to limit their access to a firearm for safety purposes?"
Intentions to Adhere to Clinician Recommendations
A structured self-report questionnaire utilized in previous research (Stanley et al., 2017; Stanley, 2018) will be used in the present study to assess participants' intentions to adhere to clinician recommendations to limit access to a firearm for safety purposes. The two items will be rated on a 10-point Likert type scale (1 = Not At All Likely; 10 = Very Likely) and they will read as follows: 1) "How likely would you be to adhere to your clinician's recommendations to limit your access to a firearm for safety purposes?"; and 2) "How likely would you be to encourage a loved one to adhere to your clinician's recommendations to limit their access to a firearm for safety purposes?"
Intentions to Adhere to Clinician Recommendations
A structured self-report questionnaire utilized in previous research (Stanley et al., 2017; Stanley, 2018) will be used in the present study to assess participants' intentions to adhere to clinician recommendations to limit access to a firearm for safety purposes. The two items will be rated on a 10-point Likert type scale (1 = Not At All Likely; 10 = Very Likely) and they will read as follows: 1) "How likely would you be to adhere to your clinician's recommendations to limit your access to a firearm for safety purposes?"; and 2) "How likely would you be to encourage a loved one to adhere to your clinician's recommendations to limit their access to a firearm for safety purposes?"
Intentions to Adhere to Clinician Recommendations
A structured self-report questionnaire utilized in previous research (Stanley et al., 2017; Stanley, 2018) will be used in the present study to assess participants' intentions to adhere to clinician recommendations to limit access to a firearm for safety purposes. The two items will be rated on a 10-point Likert type scale (1 = Not At All Likely; 10 = Very Likely) and they will read as follows: 1) "How likely would you be to adhere to your clinician's recommendations to limit your access to a firearm for safety purposes?"; and 2) "How likely would you be to encourage a loved one to adhere to your clinician's recommendations to limit their access to a firearm for safety purposes?"
Acceptability of Intervention
The acceptability of the intervention will be measured utilizing the Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 is an 8-item instrument assessing the degree to which individuals find services to be acceptable (Attkisson & Zwick, 1982; Larsen et al., 1979). Items are rated in Likert type scales ranging from 1 to 4 (e.g., 1 = Quite dissatisfied, 2 = indifferent or mildly dissatisfied, 3 = Mostly satisfied, 4 = Very satisfied). The measure utilizes a summed score (range: 8-32), with higher values being indicative of higher levels of acceptability for the services received by respondents. Items cover a broad array of acceptability standards (e.g., "How satisfied are you with the amount of help you received?", "Have the services you received helped you to deal more effectively with your problems?").
Acceptability of Intervention
The acceptability of the intervention will be measured utilizing the Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 is an 8-item instrument assessing the degree to which individuals find services to be acceptable (Attkisson & Zwick, 1982; Larsen et al., 1979). Items are rated in Likert type scales ranging from 1 to 4 (e.g., 1 = Quite dissatisfied, 2 = indifferent or mildly dissatisfied, 3 = Mostly satisfied, 4 = Very satisfied). The measure utilizes a summed score (range: 8-32), with higher values being indicative of higher levels of acceptability for the services received by respondents. Items cover a broad array of acceptability standards (e.g., "How satisfied are you with the amount of help you received?", "Have the services you received helped you to deal more effectively with your problems?").
Acceptability of Intervention
The acceptability of the intervention will be measured utilizing the Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 is an 8-item instrument assessing the degree to which individuals find services to be acceptable (Attkisson & Zwick, 1982; Larsen et al., 1979). Items are rated in Likert type scales ranging from 1 to 4 (e.g., 1 = Quite dissatisfied, 2 = indifferent or mildly dissatisfied, 3 = Mostly satisfied, 4 = Very satisfied). The measure utilizes a summed score (range: 8-32), with higher values being indicative of higher levels of acceptability for the services received by respondents. Items cover a broad array of acceptability standards (e.g., "How satisfied are you with the amount of help you received?", "Have the services you received helped you to deal more effectively with your problems?").
Acceptability of Intervention
The acceptability of the intervention will be measured utilizing the Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 is an 8-item instrument assessing the degree to which individuals find services to be acceptable (Attkisson & Zwick, 1982; Larsen et al., 1979). Items are rated in Likert type scales ranging from 1 to 4 (e.g., 1 = Quite dissatisfied, 2 = indifferent or mildly dissatisfied, 3 = Mostly satisfied, 4 = Very satisfied). The measure utilizes a summed score (range: 8-32), with higher values being indicative of higher levels of acceptability for the services received by respondents. Items cover a broad array of acceptability standards (e.g., "How satisfied are you with the amount of help you received?", "Have the services you received helped you to deal more effectively with your problems?").
Full Information
NCT ID
NCT03835585
First Posted
February 4, 2019
Last Updated
April 6, 2022
Sponsor
Florida State University
1. Study Identification
Unique Protocol Identification Number
NCT03835585
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
April 2, 2022 (Actual)
Study Completion Date
April 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Masking Description
Participants are informed that the purpose of the study is to "test the effects that providing gun locks as part of a psychological intervention has on gun safety behaviors" and that there are two treatment groups and that one is a "gun lock" group and that one is "standard intervention" group.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gun lock
Arm Type
Experimental
Arm Description
Participants will be provided a gun lock and video instructions for its proper use, in addition to standard suicide risk interventions (i.e., standardized full suicide risk assessment, safety planning, lethal means counseling).
Arm Title
Standard intervention
Arm Type
Active Comparator
Arm Description
Participants will be provided standard suicide risk interventions (i.e., standardized full suicide risk assessment, safety planning, lethal means counseling) without a gun lock. A gun lock and video instructions will be provided upon completion of the study.
Intervention Type
Device
Intervention Name(s)
Gun lock
Intervention Description
A cable-style gun lock that can be applied to a wide variety of guns for safe storage. The application of this device to most firearms renders them impossible to use properly while the device is in place and locked.
Intervention Type
Other
Intervention Name(s)
Suicide Risk Assessment
Intervention Description
Thorough suicide risk assessment according to guidelines established by research (Joiner et al., 1999; Chu et al., 2015). This is used to determine the severity of suicide risk and appropriate actions to be taken.
Intervention Type
Behavioral
Intervention Name(s)
Safety Planning
Intervention Description
A psychological intervention for suicide risk that is based on research (Chu et al., 2015; Stanley & Brown, 2012). This involves listing the following on an index card: activities individuals can use to feel better during a crisis, contact numbers that are important to the individuals, emergency options that are always accessible, and reasons for living. Although the individualized nature of safety plans does not allow for a scripted/uniform approach, for this study they will all include 8 steps and steps 5-8 (emergency options) will be the same for each individual.
Intervention Type
Behavioral
Intervention Name(s)
Lethal Means Counseling
Intervention Description
A psychological intervention for suicide risk that is based on research (Bryan et al., 2011; Chu et al., 2015; Rudd, 2006; Stanley, 2018). This involves a psychological clinician discussing, with an at-risk individual, the importance for increasing the distance/obstacles between the individual at risk for suicide and specific types of lethal means. In the present study, the lethal means targeted was firearms and the lethal means counseling approach was able to be standardized/scripted as has been done in previous research (see Stanley, 2018).
Primary Outcome Measure Information:
Title
Engagement in Firearm Safety Behaviors
Description
This includes a variety of actions and thinking patterns that promote safety regarding firearms. This is measured by a self-report instrument (Engagement in Firearm Safety Behaviors; Stanley, 2018), which contains 34 items. The items are scored on a Likert scale (i.e., 0 = Never; 1 = Sometimes, 2 = Often, 3 = Always) to gauge frequency of engagement. 16 items represent behaviors (e.g., "using a gun lock," "trading in your guns") and 18 represent thoughts (e.g., "thought about obtaining a gun lock," "thought about storing your gun unloaded.")
Time Frame
Immediately prior to intervention
Title
Engagement in Firearm Safety Behaviors
Description
This includes a variety of actions and thinking patterns that promote safety regarding firearms. This is measured by a self-report instrument (Engagement in Firearm Safety Behaviors; Stanley, 2018), which contains 34 items. The items are scored on a Likert scale (i.e., 0 = Never; 1 = Sometimes, 2 = Often, 3 = Always) to gauge frequency of engagement. 16 items represent behaviors (e.g., "using a gun lock," "trading in your guns") and 18 represent thoughts (e.g., "thought about obtaining a gun lock," "thought about storing your gun unloaded.")
Time Frame
Two weeks after intervention
Title
Engagement in Firearm Safety Behaviors
Description
This includes a variety of actions and thinking patterns that promote safety regarding firearms. This is measured by a self-report instrument (Engagement in Firearm Safety Behaviors; Stanley, 2018), which contains 34 items. The items are scored on a Likert scale (i.e., 0 = Never; 1 = Sometimes, 2 = Often, 3 = Always) to gauge frequency of engagement. 16 items represent behaviors (e.g., "using a gun lock," "trading in your guns") and 18 represent thoughts (e.g., "thought about obtaining a gun lock," "thought about storing your gun unloaded.")
Time Frame
One month after intervention
Secondary Outcome Measure Information:
Title
Intentions to Adhere to Clinician Recommendations
Description
A structured self-report questionnaire utilized in previous research (Stanley et al., 2017; Stanley, 2018) will be used in the present study to assess participants' intentions to adhere to clinician recommendations to limit access to a firearm for safety purposes. The two items will be rated on a 10-point Likert type scale (1 = Not At All Likely; 10 = Very Likely) and they will read as follows: 1) "How likely would you be to adhere to your clinician's recommendations to limit your access to a firearm for safety purposes?"; and 2) "How likely would you be to encourage a loved one to adhere to your clinician's recommendations to limit their access to a firearm for safety purposes?"
Time Frame
Immediately prior to Intervention
Title
Intentions to Adhere to Clinician Recommendations
Description
A structured self-report questionnaire utilized in previous research (Stanley et al., 2017; Stanley, 2018) will be used in the present study to assess participants' intentions to adhere to clinician recommendations to limit access to a firearm for safety purposes. The two items will be rated on a 10-point Likert type scale (1 = Not At All Likely; 10 = Very Likely) and they will read as follows: 1) "How likely would you be to adhere to your clinician's recommendations to limit your access to a firearm for safety purposes?"; and 2) "How likely would you be to encourage a loved one to adhere to your clinician's recommendations to limit their access to a firearm for safety purposes?"
Time Frame
Immediately after intervention
Title
Intentions to Adhere to Clinician Recommendations
Description
A structured self-report questionnaire utilized in previous research (Stanley et al., 2017; Stanley, 2018) will be used in the present study to assess participants' intentions to adhere to clinician recommendations to limit access to a firearm for safety purposes. The two items will be rated on a 10-point Likert type scale (1 = Not At All Likely; 10 = Very Likely) and they will read as follows: 1) "How likely would you be to adhere to your clinician's recommendations to limit your access to a firearm for safety purposes?"; and 2) "How likely would you be to encourage a loved one to adhere to your clinician's recommendations to limit their access to a firearm for safety purposes?"
Time Frame
Two weeks after intervention
Title
Intentions to Adhere to Clinician Recommendations
Description
A structured self-report questionnaire utilized in previous research (Stanley et al., 2017; Stanley, 2018) will be used in the present study to assess participants' intentions to adhere to clinician recommendations to limit access to a firearm for safety purposes. The two items will be rated on a 10-point Likert type scale (1 = Not At All Likely; 10 = Very Likely) and they will read as follows: 1) "How likely would you be to adhere to your clinician's recommendations to limit your access to a firearm for safety purposes?"; and 2) "How likely would you be to encourage a loved one to adhere to your clinician's recommendations to limit their access to a firearm for safety purposes?"
Time Frame
One month after intervention
Title
Acceptability of Intervention
Description
The acceptability of the intervention will be measured utilizing the Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 is an 8-item instrument assessing the degree to which individuals find services to be acceptable (Attkisson & Zwick, 1982; Larsen et al., 1979). Items are rated in Likert type scales ranging from 1 to 4 (e.g., 1 = Quite dissatisfied, 2 = indifferent or mildly dissatisfied, 3 = Mostly satisfied, 4 = Very satisfied). The measure utilizes a summed score (range: 8-32), with higher values being indicative of higher levels of acceptability for the services received by respondents. Items cover a broad array of acceptability standards (e.g., "How satisfied are you with the amount of help you received?", "Have the services you received helped you to deal more effectively with your problems?").
Time Frame
Immediately prior to intervention
Title
Acceptability of Intervention
Description
The acceptability of the intervention will be measured utilizing the Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 is an 8-item instrument assessing the degree to which individuals find services to be acceptable (Attkisson & Zwick, 1982; Larsen et al., 1979). Items are rated in Likert type scales ranging from 1 to 4 (e.g., 1 = Quite dissatisfied, 2 = indifferent or mildly dissatisfied, 3 = Mostly satisfied, 4 = Very satisfied). The measure utilizes a summed score (range: 8-32), with higher values being indicative of higher levels of acceptability for the services received by respondents. Items cover a broad array of acceptability standards (e.g., "How satisfied are you with the amount of help you received?", "Have the services you received helped you to deal more effectively with your problems?").
Time Frame
Immediately after intervention
Title
Acceptability of Intervention
Description
The acceptability of the intervention will be measured utilizing the Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 is an 8-item instrument assessing the degree to which individuals find services to be acceptable (Attkisson & Zwick, 1982; Larsen et al., 1979). Items are rated in Likert type scales ranging from 1 to 4 (e.g., 1 = Quite dissatisfied, 2 = indifferent or mildly dissatisfied, 3 = Mostly satisfied, 4 = Very satisfied). The measure utilizes a summed score (range: 8-32), with higher values being indicative of higher levels of acceptability for the services received by respondents. Items cover a broad array of acceptability standards (e.g., "How satisfied are you with the amount of help you received?", "Have the services you received helped you to deal more effectively with your problems?").
Time Frame
Two weeks after intervention
Title
Acceptability of Intervention
Description
The acceptability of the intervention will be measured utilizing the Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 is an 8-item instrument assessing the degree to which individuals find services to be acceptable (Attkisson & Zwick, 1982; Larsen et al., 1979). Items are rated in Likert type scales ranging from 1 to 4 (e.g., 1 = Quite dissatisfied, 2 = indifferent or mildly dissatisfied, 3 = Mostly satisfied, 4 = Very satisfied). The measure utilizes a summed score (range: 8-32), with higher values being indicative of higher levels of acceptability for the services received by respondents. Items cover a broad array of acceptability standards (e.g., "How satisfied are you with the amount of help you received?", "Have the services you received helped you to deal more effectively with your problems?").
Time Frame
One month after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas E Joiner, PhD
Organizational Affiliation
Robert O. Lawton Distinguished Professor
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bruno Chiurliza, MS
Organizational Affiliation
Graduate Student
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Gun Locks in Firearm Suicide Intervention
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