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

• ClinicalTrials.gov Identifier: NCT03375099
• Recruitment Status: Completed
• First Posted: December 15, 2017
• Last Update Posted: May 20, 2021
• Sponsor: University of Southern Mississippi
• Collaborator: University of Utah
• Information provided by (Responsible Party): University of Southern Mississippi

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.

Condition or disease	Intervention/treatment	Phase
Intentional Self-Harm by Other Specified Means	Behavioral: Lethal Means Counseling; Behavioral: Health and Stress Reduction	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 232 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: 2 (Lethal Means Counseling vs Health and Stress Reduction) x 2 (Provision of free gun locks vs No gun locks)
• Masking: Single (Participant)
• Masking Description: Participants will not be informed of the nature of the conditions other than the one they are randomly assigned to receive
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: June 1, 2017
• Actual Primary Completion Date: July 14, 2020
• Actual Study Completion Date: July 14, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Lethal Means Counseling; 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.	Behavioral: Lethal Means Counseling; Single session motivational interviewing based interaction aimed to increase the safe storage of firearms in an effort to reduce suicide risk.
Active Comparator: Lethal Means Counseling plus Gun Locks; 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.	Behavioral: Lethal Means Counseling; Single session motivational interviewing based interaction aimed to increase the safe storage of firearms in an effort to reduce suicide risk.
Active Comparator: Health and Stress Reduction; 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.	Behavioral: Health and Stress Reduction; Single session motivational interviewing based interaction aimed to reduce vulnerability to negative outcomes across four domains: sleep, diet, exercise, and stress.
Active Comparator: Health + Stress Reduction plus Gun Locks; 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.	Behavioral: Health and Stress Reduction; Single session motivational interviewing based interaction aimed to reduce vulnerability to negative outcomes across four domains: sleep, diet, exercise, and stress.

Outcome Measures

Primary Outcome Measures :

1. Changes in Safe Storage of Personal Firearms [ Time Frame: Change will be assessed at 3- and 6-month follow-up ]
   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 :

1. Perceived Cultural Competence and Likelihood of Effectiveness of Lethal Means Counseling [Acceptability and Perceived Utility] [ Time Frame: This will be assessed immediately after the intervention at baseline ]
   Degree to which lethal means counseling is experienced as culturally respectful and likely to be beneficial
2. Changes in Willingness to Seek Mental Health Care in the Future [ Time Frame: Change will be assessed immediately after the intervention and at 3- and 6-month follow-up ]
   Degree of openness to seeking future mental health care after receiving this intervention
3. Changes Openness to Means Safety in the Future [ Time Frame: Change will be assessed immediately after the intervention and at 3- and 6-month follow-up ]
   Degree of openness to voluntarily and temporarily storing firearms away from the home during hypothetical future suicidal crises

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Contacts and Locations

Locations

United States, Mississippi

University of Southern Mississippi

Hattiesburg, Mississippi, United States, 30406

Sponsors and Collaborators

University of Southern Mississippi

University of Utah

Investigators

• Principal Investigator: Michael D Anestis, PhD; Rutgers University

More Information

Publications of Results:

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.

• Responsible Party: University of Southern Mississippi
• ClinicalTrials.gov Identifier: NCT03375099
• Other Study ID Numbers: CH2-17022105
• First Posted: December 15, 2017
• Last Update Posted: May 20, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Southern Mississippi:

Firearms; Guns; Suicide; Means Safety; Means Restriction; Lethal Means Counseling

Additional relevant MeSH terms:

Self-Injurious Behavior; Behavioral Symptoms