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Identifying Effective Approaches to Counseling on Firearm Safety

Primary Purpose

Suicide

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lethal Means Counseling
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide focused on measuring Firearms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Lifetime history of suicidal ideation or a suicide attempt
  • Firearm familiarity (based on participants' self-report that they currently own a firearm, previously owned a firearm, have access to a firearm, have a desire to obtain a firearm in the future, or intend to obtain a firearm in the future)

Exclusion Criteria:

  • Younger than 18 years old
  • Imminent risk of harm to self or others necessitating hospitalization

Sites / Locations

  • Florida State University Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Low-Fear/Not-Temporary

Low-Fear/Temporary

High-Fear/Not-Temporary

High-Fear/Temporary

Arm Description

Outcomes

Primary Outcome Measures

Self-Reported Intentions to Adhere to Clinician Recommendations Scale
Actual Adherence to Clinician Recommendations Scale
Client Satisfaction Questionnaire
Credibility and Expectancy Questionnaire
Readiness to Change Scale

Secondary Outcome Measures

Full Information

First Posted
August 30, 2017
Last Updated
September 7, 2018
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT03272048
Brief Title
Identifying Effective Approaches to Counseling on Firearm Safety
Official Title
Identifying Effective Approaches to Counseling on Firearm Safety: A Randomized Experimental Design Among Firearm-familiar Individuals at Risk for Suicide
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 6, 2017 (Actual)
Primary Completion Date
April 2, 2018 (Actual)
Study Completion Date
April 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Firearms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-Fear/Not-Temporary
Arm Type
Experimental
Arm Title
Low-Fear/Temporary
Arm Type
Experimental
Arm Title
High-Fear/Not-Temporary
Arm Type
Experimental
Arm Title
High-Fear/Temporary
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Lethal Means Counseling
Intervention 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).
Primary Outcome Measure Information:
Title
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
Title
Actual Adherence to Clinician Recommendations Scale
Time Frame
Change from Pre-Intervention to One-Month Follow-Up
Title
Client Satisfaction Questionnaire
Time Frame
Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention)
Title
Credibility and Expectancy Questionnaire
Time Frame
Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention)
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Lifetime history of suicidal ideation or a suicide attempt Firearm familiarity (based on participants' self-report that they currently own a firearm, previously owned a firearm, have access to a firearm, have a desire to obtain a firearm in the future, or intend to obtain a firearm in the future) Exclusion Criteria: Younger than 18 years old Imminent risk of harm to self or others necessitating hospitalization
Facility Information:
Facility Name
Florida State University Department of Psychology
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32304
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31916797
Citation
Stanley IH, Hom MA, Sachs-Ericsson NJ, Gallyer AJ, Joiner TE. A pilot randomized clinical trial of a lethal means safety intervention for young adults with firearm familiarity at risk for suicide. J Consult Clin Psychol. 2020 Apr;88(4):372-383. doi: 10.1037/ccp0000481. Epub 2020 Jan 9.
Results Reference
derived

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Identifying Effective Approaches to Counseling on Firearm Safety

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