<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/NCT03272048</url>
  </required_header>
  <id_info>
    <org_study_id>2017.20703</org_study_id>
    <nct_id>NCT03272048</nct_id>
  </id_info>
  <brief_title>Identifying Effective Approaches to Counseling on Firearm Safety</brief_title>
  <official_title>Identifying Effective Approaches to Counseling on Firearm Safety: A Randomized Experimental Design Among Firearm-familiar Individuals at Risk for Suicide</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>
      Each year in the United States (U.S.), over 40,000 individuals die by suicide, and&#xD;
      approximately half of these deaths occur by intentional, self-inflicted gunshot wounds. Given&#xD;
      these staggering statistics, efforts to minimize individuals' access to firearms during&#xD;
      at-risk periods has been identified as a critical if fraught suicide prevention strategy.&#xD;
      Among individuals at risk for suicide who present to clinical settings, a crucial component&#xD;
      of the clinical management of suicide risk is to ask about firearm ownership/access and&#xD;
      counsel on firearm safety (e.g., encourage an at-risk person to transfer the firearm to a&#xD;
      loved one until risk abates). Despite the clinical, ethical, and in some cases legal mandate&#xD;
      of this intervention, a substantial proportion of clinicians are woefully undertrained and&#xD;
      therefore unprepared to manage suicide risk and appropriately deliver counseling on firearm&#xD;
      safety. Clinical and empirical evidence suggests that even among patients identified to be at&#xD;
      increased risk for suicide, few clinicians ask about firearms or provide counseling on&#xD;
      firearm safety. One key reason for this fissure between recommendations and actual&#xD;
      implementation of recommendations is that strategies for discussing firearm safety in a way&#xD;
      that is impactful and yields patient adherence to recommendations have yet to be established.&#xD;
&#xD;
      One common approach to attempt to garner pro-health behavior change is the use of fear&#xD;
      appeals; however, research on the utility of this approach across non-firearm-related health&#xD;
      interventions has been equivocal. Given the cultural importance placed on firearms in the&#xD;
      U.S., the investigators contend that fear-based approaches to lethal means counseling may be&#xD;
      counter-productive by creating defensive avoidance, thereby detracting from the purpose of&#xD;
      counseling on firearm safety (i.e., patient safety).&#xD;
&#xD;
      Further, patient adherence to recommendations to limit access to a firearm during at-risk&#xD;
      periods may be increased when clinicians emphasize that limits on firearm access will decline&#xD;
      when suicide risk abates (i.e., limits on firearm access will likely not be permanent).&#xD;
      However, research has yet to determine if varying the level of fear messaging and/or emphasis&#xD;
      on temporariness is actually useful and acceptable.&#xD;
&#xD;
      To address this gap, the investigators will randomly assign participants to one of four&#xD;
      experimental conditions: (1) low-fear/not-temporary; (2) low-fear/temporary; (3)&#xD;
      high-fear/not-temporary; and (4) high-fear/temporary. Participants include undergraduate&#xD;
      students who are vulnerable to suicide and reported owning or previously owning a firearm,&#xD;
      reported access to a firearm, or reported possibly obtaining a firearm in the future. The&#xD;
      investigators hypothesized that individuals randomly assigned to the low-fear/temporary group&#xD;
      will (1) report greater intentions to adhere to recommendations to limit access to firearms&#xD;
      during at-risk periods than the other groups at both post-intervention and one-month&#xD;
      follow-up; (2) report greater actual adherence to recommendations at one-month follow-up; and&#xD;
      (3) rate the lethal means counseling session as more acceptable than the other groups.&#xD;
      Exploratory aims examined if the effects differed for individuals reporting actual current&#xD;
      firearm ownership or access, membership in the National Rifle Association (NRA) or a similar&#xD;
      organization, political affiliation, political ideology, greater personal importance of the&#xD;
      Second Amendment, or severity of suicidal symptoms. Findings have the potential to inform&#xD;
      clinical and public health approaches to limit at-risk individuals' access to firearms for&#xD;
      safety purposes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 6, 2017</start_date>
  <completion_date type="Actual">April 2, 2018</completion_date>
  <primary_completion_date type="Actual">April 2, 2018</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-Reported Intentions to Adhere to Clinician Recommendations Scale</measure>
    <time_frame>Change from Pre-Intervention to (a) Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention) and (b) One-Month Follow-Up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Actual Adherence to Clinician Recommendations Scale</measure>
    <time_frame>Change from Pre-Intervention to One-Month Follow-Up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Client Satisfaction Questionnaire</measure>
    <time_frame>Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Credibility and Expectancy Questionnaire</measure>
    <time_frame>Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Readiness to Change Scale</measure>
    <time_frame>Change from Pre-Intervention to (a) Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention) and (b) One-Month Follow-Up</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Suicide</condition>
  <arm_group>
    <arm_group_label>Low-Fear/Not-Temporary</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-Fear/Temporary</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High-Fear/Not-Temporary</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High-Fear/Temporary</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lethal Means Counseling</intervention_name>
    <description>Lethal means counseling is broadly defined as clinician-initiated discussions that encourage an individual at risk for suicide to safely store his or her firearms. Examples in this domain include applying a gun lock, separating the gun from its ammunition, dismantling the firearm and keeping its components locked and/or separated, or safely transferring the firearm to a trusted loved one, friend, or police station until risk abates (Bryan, Stone, &amp; Rudd, 2011; Jin, Khazem, &amp; Anestis, 2016). Further, given that recent purchasers of firearms are at markedly increased risk of death by suicide (Wintemute, Parham, Beaumont, Wright, &amp; Drake, 1999), anticipatory counseling on firearm safety should also be considered for at-risk individuals who do not report currently owning or having access to a firearm, but who report prior firearm ownership/access or intentions of obtaining a firearm in the future (Harvard T.H. Chan School of Public Health, 2017).</description>
    <arm_group_label>High-Fear/Not-Temporary</arm_group_label>
    <arm_group_label>High-Fear/Temporary</arm_group_label>
    <arm_group_label>Low-Fear/Not-Temporary</arm_group_label>
    <arm_group_label>Low-Fear/Temporary</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lifetime history of suicidal ideation or a suicide attempt&#xD;
&#xD;
          -  Firearm familiarity (based on participants' self-report that they currently own a&#xD;
             firearm, previously owned a firearm, have access to a firearm, have a desire to obtain&#xD;
             a firearm in the future, or intend to obtain a firearm in the future)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 years old&#xD;
&#xD;
          -  Imminent risk of harm to self or others necessitating hospitalization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Florida State University Department of Psychology</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 7, 2018</last_update_submitted>
  <last_update_submitted_qc>September 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Florida State University</investigator_affiliation>
    <investigator_full_name>Ian Stanley</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Firearms</keyword>
  <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/NCT03272048
org study id: 2017.20703
nct id: NCT03272048
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Each year in the United States (U.S.), over 40,000 individuals die by suicide, and
      approximately half of these deaths occur by intentional, self-inflicted gunshot wounds. Given
      these staggering statistics, efforts to minimize individuals' access to firearms during
      at-risk periods has been identified as a critical if fraught suicide prevention strategy.
      Among individuals at risk for suicide who present to clinical settings, a crucial component
      of the clinical management of suicide risk is to ask about firearm ownership/access and
      counsel on firearm safety (e.g., encourage an at-risk person to transfer the firearm to a
      loved one until risk abates). Despite the clinical, ethical, and in some cases legal mandate
      of this intervention, a substantial proportion of clinicians are woefully undertrained and
      therefore unprepared to manage suicide risk and appropriately deliver counseling on firearm
      safety. Clinical and empirical evidence suggests that even among patients identified to be at
      increased risk for suicide, few clinicians ask about firearms or provide counseling on
      firearm safety. One key reason for this fissure between recommendations and actual
      implementation of recommendations is that strategies for discussing firearm safety in a way
      that is impactful and yields patient adherence to recommendations have yet to be established.

      One common approach to attempt to garner pro-health behavior change is the use of fear
      appeals; however, research on the utility of this approach across non-firearm-related health
      interventions has been equivocal. Given the cultural importance placed on firearms in the
      U.S., the investigators contend that fear-based approaches to lethal means counseling may be
      counter-productive by creating defensive avoidance, thereby detracting from the purpose of
      counseling on firearm safety (i.e., patient safety).

      Further, patient adherence to recommendations to limit access to a firearm during at-risk
      periods may be increased when clinicians emphasize that limits on firearm access will decline
      when suicide risk abates (i.e., limits on firearm access will likely not be permanent).
      However, research has yet to determine if varying the level of fear messaging and/or emphasis
      on temporariness is actually useful and acceptable.

      To address this gap, the investigators will randomly assign participants to one of four
      experimental conditions: (1) low-fear/not-temporary; (2) low-fear/temporary; (3)
      high-fear/not-temporary; and (4) high-fear/temporary. Participants include undergraduate
      students who are vulnerable to suicide and reported owning or previously owning a firearm,
      reported access to a firearm, or reported possibly obtaining a firearm in the future. The
      investigators hypothesized that individuals randomly assigned to the low-fear/temporary group
      will (1) report greater intentions to adhere to recommendations to limit access to firearms
      during at-risk periods than the other groups at both post-intervention and one-month
      follow-up; (2) report greater actual adherence to recommendations at one-month follow-up; and
      (3) rate the lethal means counseling session as more acceptable than the other groups.
      Exploratory aims examined if the effects differed for individuals reporting actual current
      firearm ownership or access, membership in the National Rifle Association (NRA) or a similar
      organization, political affiliation, political ideology, greater personal importance of the
      Second Amendment, or severity of suicidal symptoms. Findings have the potential to inform
      clinical and public health approaches to limit at-risk individuals' access to firearms for
      safety purposes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Self-Reported Intentions to Adhere to Clinician Recommendations Scale
time frame: Change from Pre-Intervention to (a) Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention) and (b) One-Month Follow-Up
measure: Actual Adherence to Clinician Recommendations Scale
time frame: Change from Pre-Intervention to One-Month Follow-Up
measure: Client Satisfaction Questionnaire
time frame: Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention)
measure: Credibility and Expectancy Questionnaire
time frame: Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention)
measure: Readiness to Change Scale
time frame: Change from Pre-Intervention to (a) Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention) and (b) One-Month Follow-Up
arm group label: Low-Fear/Not-Temporary
arm group type: Experimental
arm group label: Low-Fear/Temporary
arm group type: Experimental
arm group label: High-Fear/Not-Temporary
arm group type: Experimental
arm group label: High-Fear/Temporary
arm group type: Experimental
intervention type: Behavioral
intervention name: Lethal Means Counseling
description: Lethal means counseling is broadly defined as clinician-initiated discussions that encourage an individual at risk for suicide to safely store his or her firearms. Examples in this domain include applying a gun lock, separating the gun from its ammunition, dismantling the firearm and keeping its components locked and/or separated, or safely transferring the firearm to a trusted loved one, friend, or police station until risk abates (Bryan, Stone, & Rudd, 2011; Jin, Khazem, & Anestis, 2016). Further, given that recent purchasers of firearms are at markedly increased risk of death by suicide (Wintemute, Parham, Beaumont, Wright, & Drake, 1999), anticipatory counseling on firearm safety should also be considered for at-risk individuals who do not report currently owning or having access to a firearm, but who report prior firearm ownership/access or intentions of obtaining a firearm in the future (Harvard T.H. Chan School of Public Health, 2017).
arm group label: High-Fear/Not-Temporary
arm group label: High-Fear/Temporary
arm group label: Low-Fear/Not-Temporary
arm group label: Low-Fear/Temporary
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Florida State University
investigator full name: Ian Stanley
investigator title: Principal Investigator
mesh term: Suicide