NCT03375099

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 15, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2020

Completed
Last Updated

May 20, 2021

Status Verified

May 1, 2021

Enrollment Period

3.1 years

First QC Date

November 13, 2017

Last Update Submit

May 17, 2021

Conditions

Keywords

FirearmsGunsSuicideMeans SafetyMeans RestrictionLethal Means Counseling

Outcome Measures

Primary Outcomes (1)

  • 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)

    Change will be assessed at 3- and 6-month follow-up

Secondary Outcomes (3)

  • Perceived Cultural Competence and Likelihood of Effectiveness of Lethal Means Counseling [Acceptability and Perceived Utility]

    This will be assessed immediately after the intervention at baseline

  • Changes in Willingness to Seek Mental Health Care in the Future

    Change will be assessed immediately after the intervention and at 3- and 6-month follow-up

  • Changes Openness to Means Safety in the Future

    Change will be assessed immediately after the intervention and at 3- and 6-month follow-up

Study Arms (4)

Lethal Means Counseling

EXPERIMENTAL

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

Lethal Means Counseling plus Gun Locks

ACTIVE COMPARATOR

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

Health and Stress Reduction

ACTIVE COMPARATOR

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

Health + Stress Reduction plus Gun Locks

ACTIVE COMPARATOR

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

Interventions

Single session motivational interviewing based interaction aimed to increase the safe storage of firearms in an effort to reduce suicide risk.

Lethal Means CounselingLethal Means Counseling plus Gun Locks

Single session motivational interviewing based interaction aimed to reduce vulnerability to negative outcomes across four domains: sleep, diet, exercise, and stress.

Health + Stress Reduction plus Gun LocksHealth and Stress Reduction

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Mississippi

Hattiesburg, Mississippi, 30406, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Suicide

Interventions

Health

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Michael D Anestis, PhD

    Rutgers University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be informed of the nature of the conditions other than the one they are randomly assigned to receive
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 2 (Lethal Means Counseling vs Health and Stress Reduction) x 2 (Provision of free gun locks vs No gun locks)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2017

First Posted

December 15, 2017

Study Start

June 1, 2017

Primary Completion

July 14, 2020

Study Completion

July 14, 2020

Last Updated

May 20, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

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.

Locations