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Comparison of Lethal Means Counseling and an Active Control Condition, With and Without Provision of Gun Locks

Primary Purpose

Intentional Self-Harm by Other Specified Means

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lethal Means Counseling
Health and Stress Reduction
Sponsored by
University of Southern Mississippi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intentional Self-Harm by Other Specified Means focused on measuring Firearms, Guns, Suicide, Means Safety, Means Restriction, Lethal Means Counseling

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Affiliated with the National Guard
  • Owns at least one personal firearm
  • Speaks English fluently

Exclusion Criteria:

  • N/A

Sites / Locations

  • University of Southern Mississippi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Lethal Means Counseling

Lethal Means Counseling plus Gun Locks

Health and Stress Reduction

Health + Stress Reduction plus Gun Locks

Arm Description

National Guard Personnel will receive a single 15-25 minute session of lethal means counseling. The session will focus on increasing the safety of current storage practices for personal firearms (e.g., storing unloaded in a secure location separate from ammunition) as well as planning to voluntarily and temporarily store firearms away from the home during any future hypothetical suicidal crisis. This intervention utilizes a motivational interviewing framework in an effort to remain sensitive to the views and culture of firearm owners.

National Guard Personnel will receive a single 15-25 minute session of lethal means counseling. The session will focus on increasing the safety of current storage practices for personal firearms (e.g., storing unloaded in a secure location separate from ammunition) as well as planning to voluntarily and temporarily store firearms away from the home during any future hypothetical suicidal crisis. This intervention utilizes a motivational interviewing framework in an effort to remain sensitive to the views and culture of firearm owners. Individuals in this condition will also receive a free gun (cable) lock for each of their personal firearms.

Individuals in this condition will take part in a single 15-25 minute session focused on reducing health vulnerabilities in one of four areas: diet, exercise, sleep, or stress. This condition is designed to control for the effects of active interaction with a clinicians (e.g. common factors). As with the experimental condition, this session will utilize a motivational interviewing framework.

Individuals in this condition will take part in a single 15-25 minute session focused on reducing health vulnerabilities in one of four areas: diet, exercise, sleep, or stress. This condition is designed to control for the effects of active interaction with a clinicians (e.g. common factors). As with the experimental condition, this session will utilize a motivational interviewing framework. Individuals randomized to this condition will also receive a free gun (cable) lock for each of their personal firearms. This will control for whether the effect of the provision of gun locks is accounted for by the simultaneous use of lethal means counseling.

Outcomes

Primary Outcome Measures

Changes in Safe Storage of Personal Firearms
Whether firearms are stored (1) in a lock box or gun safe (yes/no) (2) loaded (yes/no) (3) separate from ammunition (yes/no) and (4) using a locking device (e.g. cable lock; yes/no)

Secondary Outcome Measures

Perceived Cultural Competence and Likelihood of Effectiveness of Lethal Means Counseling [Acceptability and Perceived Utility]
Degree to which lethal means counseling is experienced as culturally respectful and likely to be beneficial
Changes in Willingness to Seek Mental Health Care in the Future
Degree of openness to seeking future mental health care after receiving this intervention
Changes Openness to Means Safety in the Future
Degree of openness to voluntarily and temporarily storing firearms away from the home during hypothetical future suicidal crises

Full Information

First Posted
November 13, 2017
Last Updated
May 17, 2021
Sponsor
University of Southern Mississippi
Collaborators
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT03375099
Brief Title
Comparison of Lethal Means Counseling and an Active Control Condition, With and Without Provision of Gun Locks
Official Title
Comparison of Lethal Means Counseling and an Active Control Condition, With and Without Provision of Gun Locks for Improving Safe Storage of Personal Firearms Among National Guard Personnel
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
July 14, 2020 (Actual)
Study Completion Date
July 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Mississippi
Collaborators
University of Utah

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
In 2013, the National Guard reported a suicide rate that was substantially higher than both the general population and the active duty component of the United States military. The prototypical National Guard suicide decedent appears to be a young male firearm owner not currently deployed who dies using his own gun. Prior research within the military has revealed that soldiers are unlikely to seek out or engage in mental health services. In sum, current best practices in suicide risk assessment are poorly equipped to identify the individuals most likely to die by suicide. This study aims to examine the acceptability, feasibility, and utility of a single lethal means counseling session as part of a suicide prevention approach targeting demographic groups overrepresented in National Guard firearm suicides. 232 firearm-owning National Guard personnel will be randomized to one of four conditions, each of which requires a single 15-25 minute session: (1) lethal means counseling (2) lethal means counseling plus the provision of free gun locks (3) health and stress control condition (4) health and stress control condition plus the provision of free gun locks. The investigators anticipate that those who receive lethal means counseling will subsequently store their personal firearms more safely and report being more willing to store their firearms away from the home during any hypothetical future suicidal crisis. The overarching goal of each hypothesis is to examine the extent to which gun owning young male National Guard personnel at varying levels of suicide risk are willing to engage in means safety.
Detailed Description
In 2013, the National Guard reported a suicide rate that was substantially higher than both the general population and the active duty component of the United States military. The prototypical National Guard suicide decedent appears to be a young male firearm owner not currently deployed who dies using his own gun. Prior research within the military has revealed that soldiers are unlikely to seek out or engage in mental health services. In sum, current best practices in suicide risk assessment are poorly equipped to identify the individuals most likely to die by suicide. This study aims to examine the acceptability, feasibility, and utility of a single lethal means counseling session as part of a suicide prevention approach targeting demographic groups overrepresented in National Guard firearm suicides. The study will utilize a 2x2 Factorial Design: Intervention (Lethal Means Counseling, Health and Stress Control) X Gun-Lock (Provided, Not Provided). Participants will be 232 firearm owning National Guard personnel. Lethal Means Counseling comprises education on risk factors for suicide, information on preventative resources, and encouragement to store guns safely and to temporarily remove guns during high risk periods. The Health and Stress Program is designed to control for effects of general mental and physical health education in the active condition. Each condition utilizes a motivational interviewing framework. The overarching goal of each hypothesis is to examine the extent to which gun owning young male National Guard personnel at varying levels of suicide risk are willing to engage in safety planning and find means safety approaches acceptable

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intentional Self-Harm by Other Specified Means
Keywords
Firearms, Guns, Suicide, Means Safety, Means Restriction, Lethal Means Counseling

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2 (Lethal Means Counseling vs Health and Stress Reduction) x 2 (Provision of free gun locks vs No gun locks)
Masking
Participant
Masking Description
Participants will not be informed of the nature of the conditions other than the one they are randomly assigned to receive
Allocation
Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lethal Means Counseling
Arm Type
Experimental
Arm Description
National Guard Personnel will receive a single 15-25 minute session of lethal means counseling. The session will focus on increasing the safety of current storage practices for personal firearms (e.g., storing unloaded in a secure location separate from ammunition) as well as planning to voluntarily and temporarily store firearms away from the home during any future hypothetical suicidal crisis. This intervention utilizes a motivational interviewing framework in an effort to remain sensitive to the views and culture of firearm owners.
Arm Title
Lethal Means Counseling plus Gun Locks
Arm Type
Active Comparator
Arm Description
National Guard Personnel will receive a single 15-25 minute session of lethal means counseling. The session will focus on increasing the safety of current storage practices for personal firearms (e.g., storing unloaded in a secure location separate from ammunition) as well as planning to voluntarily and temporarily store firearms away from the home during any future hypothetical suicidal crisis. This intervention utilizes a motivational interviewing framework in an effort to remain sensitive to the views and culture of firearm owners. Individuals in this condition will also receive a free gun (cable) lock for each of their personal firearms.
Arm Title
Health and Stress Reduction
Arm Type
Active Comparator
Arm Description
Individuals in this condition will take part in a single 15-25 minute session focused on reducing health vulnerabilities in one of four areas: diet, exercise, sleep, or stress. This condition is designed to control for the effects of active interaction with a clinicians (e.g. common factors). As with the experimental condition, this session will utilize a motivational interviewing framework.
Arm Title
Health + Stress Reduction plus Gun Locks
Arm Type
Active Comparator
Arm Description
Individuals in this condition will take part in a single 15-25 minute session focused on reducing health vulnerabilities in one of four areas: diet, exercise, sleep, or stress. This condition is designed to control for the effects of active interaction with a clinicians (e.g. common factors). As with the experimental condition, this session will utilize a motivational interviewing framework. Individuals randomized to this condition will also receive a free gun (cable) lock for each of their personal firearms. This will control for whether the effect of the provision of gun locks is accounted for by the simultaneous use of lethal means counseling.
Intervention Type
Behavioral
Intervention Name(s)
Lethal Means Counseling
Intervention Description
Single session motivational interviewing based interaction aimed to increase the safe storage of firearms in an effort to reduce suicide risk.
Intervention Type
Behavioral
Intervention Name(s)
Health and Stress Reduction
Intervention Description
Single session motivational interviewing based interaction aimed to reduce vulnerability to negative outcomes across four domains: sleep, diet, exercise, and stress.
Primary Outcome Measure Information:
Title
Changes in Safe Storage of Personal Firearms
Description
Whether firearms are stored (1) in a lock box or gun safe (yes/no) (2) loaded (yes/no) (3) separate from ammunition (yes/no) and (4) using a locking device (e.g. cable lock; yes/no)
Time Frame
Change will be assessed at 3- and 6-month follow-up
Secondary Outcome Measure Information:
Title
Perceived Cultural Competence and Likelihood of Effectiveness of Lethal Means Counseling [Acceptability and Perceived Utility]
Description
Degree to which lethal means counseling is experienced as culturally respectful and likely to be beneficial
Time Frame
This will be assessed immediately after the intervention at baseline
Title
Changes in Willingness to Seek Mental Health Care in the Future
Description
Degree of openness to seeking future mental health care after receiving this intervention
Time Frame
Change will be assessed immediately after the intervention and at 3- and 6-month follow-up
Title
Changes Openness to Means Safety in the Future
Description
Degree of openness to voluntarily and temporarily storing firearms away from the home during hypothetical future suicidal crises
Time Frame
Change will be assessed immediately after the intervention and at 3- and 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Affiliated with the National Guard Owns at least one personal firearm Speaks English fluently Exclusion Criteria: N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D Anestis, PhD
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern Mississippi
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
30406
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are open to collaborating with other researchers and making data available on an individual basis. No personally identifiable information would be included and we would first seek the approval of the funding agency (Military Suicide Research Consortium) due to their use of Common Data Elements.
Citations:
PubMed Identifier
33351652
Citation
Anestis MD, Bryan CJ, Capron DW, Bryan AO. Lethal Means Counseling, Distribution of Cable Locks, and Safe Firearm Storage Practices Among the Mississippi National Guard: A Factorial Randomized Controlled Trial, 2018-2020. Am J Public Health. 2021 Feb;111(2):309-317. doi: 10.2105/AJPH.2020.306019. Epub 2020 Dec 22.
Results Reference
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Comparison of Lethal Means Counseling and an Active Control Condition, With and Without Provision of Gun Locks

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