<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03835585</url>
  </required_header>
  <id_info>
    <org_study_id>HSC#: 2018.26057</org_study_id>
    <nct_id>NCT03835585</nct_id>
  </id_info>
  <brief_title>Gun Locks in Firearm Suicide Intervention</brief_title>
  <official_title>The Provision of Gun Locks in Lethal Means Counseling to Increase Firearm Safety in a Suicide Risk Sample</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Florida State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares the effectiveness of two interventions for suicide over the course of a&#xD;
      month. The experimental intervention includes the provision of a gun lock with video&#xD;
      instructions, in addition to standard suicide risk interventions (i.e., standardized full&#xD;
      suicide risk assessment, safety planning, and lethal means counseling). The comparison&#xD;
      intervention group will receive the same standard suicide risk interventions without the gun&#xD;
      lock and video. The targeted outcome will be level of engagement in gun safety behaviors&#xD;
      (e.g., using a gun lock, using a gun safe, considering getting rid of guns). It is predicted&#xD;
      that the experimental intervention will result in greater increases over time in engagement&#xD;
      in gun safety behaviors, as compared to the comparison intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose: While psychology research and the suicide literature have not provided this evidence&#xD;
      in a manner relevant to lethal means counseling, research across various disciplines has&#xD;
      clearly demonstrated that providing individuals with gun locks and knowledgeable information&#xD;
      about their proper use will significantly increase the likelihood that individuals will&#xD;
      engage in firearm safety behaviors. The present study seeks to examine if the provision of&#xD;
      gun locks, in addition to the current best standard interventions for suicide risk according&#xD;
      to research, will significantly increase engagement in these behavioral outcomes.&#xD;
&#xD;
      Research Design/Method: The present study will utilize an experimental design with two&#xD;
      groups, an experimental intervention group and a comparison intervention group. The&#xD;
      experimental intervention group will receive the highest standard interventions (i.e.,&#xD;
      standardized full suicide risk assessment, safety planning, and lethal means counseling) in&#xD;
      addition to a gun lock and instructional video. The comparison intervention group will&#xD;
      receive the highest standard interventions, but will not be provided gun locks until after&#xD;
      the study is complete.&#xD;
&#xD;
      The gun locks will be 15-inch cable locks. Locks will be mailed via USPS in envelopes upon&#xD;
      completion of screener, if eligible for the study, but before they are scheduled to complete&#xD;
      the first portion of the study. this will be arranged by making scheduling calls for initial&#xD;
      sessions the day of/day after (depending on time) screeners are completed, scheduling initial&#xD;
      sessions at least a week and a half after scheduling calls, and mailing the locks the day of&#xD;
      scheduling calls.&#xD;
&#xD;
      Gun locks will be mailed to participants in the experimental intervention group. Data will be&#xD;
      collected over three sessions. The first will be when baseline measures (e.g., demographics,&#xD;
      outcomes) will be administered online, the intervention will be provided for all individuals&#xD;
      by phone and online(only for the video instructions for lock), and post-intervention measures&#xD;
      of outcome variables will assessed online. The 2-week follow-up interval and the 1-month&#xD;
      interval will involve only assessment of the outcomes online. Participants in comparison&#xD;
      intervention group will be provided gun locks after participation in the study is complete.&#xD;
&#xD;
      Research Question: Will the experimental intervention group outperform the comparison&#xD;
      intervention group, regarding effectiveness in increasing engagement in firearm safety&#xD;
      behaviors?&#xD;
&#xD;
      Hypothesis: The intervention for the experimental intervention group will be significantly&#xD;
      more effective at increasing engagement in firearm safety behavior than that which will be&#xD;
      provided for the comparison intervention group.&#xD;
&#xD;
      Data Analysis: Repeated Measures Analysis of Variance (RM-ANOVA) will be conducted, with a&#xD;
      focus on measuring the interaction effects of Group and Time to assess whether experimental&#xD;
      intervention group was significantly more effective than the comparison intervention group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Actual">April 2, 2022</completion_date>
  <primary_completion_date type="Actual">April 2, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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).</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Participants are informed that the purpose of the study is to &quot;test the effects that providing gun locks as part of a psychological intervention has on gun safety behaviors&quot; and that there are two treatment groups and that one is a &quot;gun lock&quot; group and that one is &quot;standard intervention&quot; group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Engagement in Firearm Safety Behaviors</measure>
    <time_frame>Immediately prior to intervention</time_frame>
    <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., &quot;using a gun lock,&quot; &quot;trading in your guns&quot;) and 18 represent thoughts (e.g., &quot;thought about obtaining a gun lock,&quot; &quot;thought about storing your gun unloaded.&quot;)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Engagement in Firearm Safety Behaviors</measure>
    <time_frame>Two weeks after intervention</time_frame>
    <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., &quot;using a gun lock,&quot; &quot;trading in your guns&quot;) and 18 represent thoughts (e.g., &quot;thought about obtaining a gun lock,&quot; &quot;thought about storing your gun unloaded.&quot;)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Engagement in Firearm Safety Behaviors</measure>
    <time_frame>One month after intervention</time_frame>
    <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., &quot;using a gun lock,&quot; &quot;trading in your guns&quot;) and 18 represent thoughts (e.g., &quot;thought about obtaining a gun lock,&quot; &quot;thought about storing your gun unloaded.&quot;)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intentions to Adhere to Clinician Recommendations</measure>
    <time_frame>Immediately prior to Intervention</time_frame>
    <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) &quot;How likely would you be to adhere to your clinician's recommendations to limit your access to a firearm for safety purposes?&quot;; and 2) &quot;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?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intentions to Adhere to Clinician Recommendations</measure>
    <time_frame>Immediately after intervention</time_frame>
    <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) &quot;How likely would you be to adhere to your clinician's recommendations to limit your access to a firearm for safety purposes?&quot;; and 2) &quot;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?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intentions to Adhere to Clinician Recommendations</measure>
    <time_frame>Two weeks after intervention</time_frame>
    <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) &quot;How likely would you be to adhere to your clinician's recommendations to limit your access to a firearm for safety purposes?&quot;; and 2) &quot;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?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intentions to Adhere to Clinician Recommendations</measure>
    <time_frame>One month after intervention</time_frame>
    <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) &quot;How likely would you be to adhere to your clinician's recommendations to limit your access to a firearm for safety purposes?&quot;; and 2) &quot;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?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of Intervention</measure>
    <time_frame>Immediately prior to intervention</time_frame>
    <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 &amp; 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., &quot;How satisfied are you with the amount of help you received?&quot;, &quot;Have the services you received helped you to deal more effectively with your problems?&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of Intervention</measure>
    <time_frame>Immediately after intervention</time_frame>
    <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 &amp; 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., &quot;How satisfied are you with the amount of help you received?&quot;, &quot;Have the services you received helped you to deal more effectively with your problems?&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of Intervention</measure>
    <time_frame>Two weeks after intervention</time_frame>
    <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 &amp; 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., &quot;How satisfied are you with the amount of help you received?&quot;, &quot;Have the services you received helped you to deal more effectively with your problems?&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of Intervention</measure>
    <time_frame>One month after intervention</time_frame>
    <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 &amp; 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., &quot;How satisfied are you with the amount of help you received?&quot;, &quot;Have the services you received helped you to deal more effectively with your problems?&quot;).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Suicide</condition>
  <arm_group>
    <arm_group_label>Gun lock</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Gun lock</intervention_name>
    <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.</description>
    <arm_group_label>Gun lock</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Suicide Risk Assessment</intervention_name>
    <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.</description>
    <arm_group_label>Gun lock</arm_group_label>
    <arm_group_label>Standard intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Safety Planning</intervention_name>
    <description>A psychological intervention for suicide risk that is based on research (Chu et al., 2015; Stanley &amp; 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.</description>
    <arm_group_label>Gun lock</arm_group_label>
    <arm_group_label>Standard intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lethal Means Counseling</intervention_name>
    <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).</description>
    <arm_group_label>Gun lock</arm_group_label>
    <arm_group_label>Standard intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must own and have access to a firearm&#xD;
&#xD;
          -  Must have at least one lifetime episode of suicide ideation&#xD;
&#xD;
          -  Must be 18 years of age or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - May not be under 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas E Joiner, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Robert O. Lawton Distinguished Professor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bruno Chiurliza, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Graduate Student</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Florida State University</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03835585
org study id: HSC#: 2018.26057
nct id: NCT03835585
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
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
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.
measure: Engagement in Firearm Safety Behaviors
time frame: Immediately prior to intervention
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.")
measure: Engagement in Firearm Safety Behaviors
time frame: Two weeks after intervention
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.")
measure: Engagement in Firearm Safety Behaviors
time frame: One month after intervention
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.")
measure: Intentions to Adhere to Clinician Recommendations
time frame: Immediately prior to Intervention
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?"
measure: Intentions to Adhere to Clinician Recommendations
time frame: Immediately after intervention
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?"
measure: Intentions to Adhere to Clinician Recommendations
time frame: Two weeks after intervention
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?"
measure: Intentions to Adhere to Clinician Recommendations
time frame: One month after intervention
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?"
measure: Acceptability of Intervention
time frame: Immediately prior to 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?").
measure: Acceptability of Intervention
time frame: Immediately after 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?").
measure: Acceptability of Intervention
time frame: Two weeks after 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?").
measure: Acceptability of Intervention
time frame: One month after 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?").
arm group label: Gun lock
arm group type: Experimental
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 group label: Standard intervention
arm group type: Active Comparator
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: Gun lock
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.
arm group label: Gun lock
intervention type: Other
intervention name: Suicide Risk Assessment
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.
arm group label: Gun lock
arm group label: Standard intervention
intervention type: Behavioral
intervention name: Safety Planning
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.
arm group label: Gun lock
arm group label: Standard intervention
intervention type: Behavioral
intervention name: Lethal Means Counseling
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).
arm group label: Gun lock
arm group label: Standard intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas E Joiner, PhD
role: Study Director
affiliation: Robert O. Lawton Distinguished Professor
last name: Bruno Chiurliza, MS
role: Principal Investigator
affiliation: Graduate Student
facility: 
country: United States
responsible party type: Sponsor
mesh term: Suicide