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SuicideNCT03835585

Gun Locks in Firearm Suicide Intervention

A study testing Gun lock, Suicide Risk Assessment and Safety Planning in people with Suicide, run by Florida State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Suicide
What is being tested?
Gun lock, Suicide Risk Assessment and Safety Planning
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Nov 2019to 2 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • May not be under 18 years of age

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Florida State University

    Tallahassee, Florida, 32306

Other trials in United States

About this study

Official title: The Provision of Gun Locks in Lethal Means Counseling to Increase Firearm Safety in a Suicide Risk Sample

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.

Read the 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.

Conditions
Suicide
Being tested
Gun lock, Suicide Risk Assessment, Safety Planning, Lethal Means Counseling
Medical subject headings
Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gun lockDevice

    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.

  • Suicide Risk AssessmentOther

    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.

  • Safety PlanningBehavioural

    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.

  • Lethal Means CounselingBehavioural

    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).

Study groups in NCT03835585
Study groupRoleWhat they receive
Gun lockExperimentalParticipants 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).
Receives: Device: Gun lock; Other: Suicide Risk Assessment; Behavioral: Safety Planning; Behavioral: Lethal Means Counseling
Standard interventionActive comparatorParticipants 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.
Receives: Other: Suicide Risk Assessment; Behavioral: Safety Planning; Behavioral: Lethal Means Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.")

    Measured: Immediately prior to intervention

  2. 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.")

    Measured: Two weeks after intervention

  3. 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.")

    Measured: One month after intervention

Secondary outcomes (8)
  1. 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?"

    Measured: Immediately prior to Intervention

  2. 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?"

    Measured: Immediately after intervention

  3. 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?"

    Measured: Two weeks after intervention

  4. 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?"

    Measured: One month after intervention

  5. 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?").

    Measured: Immediately prior to intervention

  6. 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?").

    Measured: Immediately after intervention

  7. 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?").

    Measured: Two weeks after intervention

  8. 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?").

    Measured: One month after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2019
  2. Study start1 Nov 2019
  3. Primary completion2 Apr 2022
  4. Study completion2 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03835585
Sponsor's protocol ID
HSC#: 2018.26057
Status last verified
Apr 2022
First submitted
4 Feb 2019
Last updated
8 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Gun lock, Suicide Risk Assessment and Safety Planning in people with Suicide, run by Florida State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Engagement in Firearm Safety Behaviors (time frame: Immediately prior to intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.

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Gun Locks in Firearm Suicide Intervention | AzTrials