ClinicalTrials.gg
CompletedNCT03375099Updated May 20, 2021

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

An interventional study of Lethal Means Counseling and Health and Stress Reduction in Intentional Self-Harm by Other Specified Means, sponsored by University of Southern Mississippi. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-20.

Sponsored by University of Southern Mississippi · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jun 2017, registered Nov 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
232
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 386 studies in Suicide with a site in United States — 99 open to participants now, 113 under way, 2 of them phase 3. Suicide · United States.

Enrollment
98th of 348
232 · median 91
Started
2017
with 16 others
No phase
288 of 386
80 open now
Registered
125th of 386
by date

Among the 386 studies in Suicide with a site in United States, this one is the 98th largest by enrollment of the 348 interventional ones, is one of 17 that started in 2017, is one of 288 with no phase, and was the 125th registered.

By phase

386 studies; the count open now beside each. This study's row is marked.

No phasethis study288 · 80 open
Observational36 · 5 open
Phase 218 · 7 open
Phase 116 · 3 open
Phase 411 · 0 open
Phase 1/27 · 3 open
Phase 2/35 · 1 open
Phase 35 · 0 open

By the year they started

First in 1990; this study’s year is marked. 17 started in 2017.

Size and results

Median enrollment 91 across the 348 interventional studies, 172 across the 36 observational. Of the 251 that completed or were terminated, 103 (41%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 386 studies in Suicide with a site in United States, or all of them as a file.
02

Study 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.

Read the 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

03

Conditions studied

  • Intentional Self-Harm by Other Specified Means

Browse trials for

Keywords

  • Firearms
  • Guns
  • Suicide
  • Means Safety
  • Means Restriction
  • Lethal Means Counseling
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • N/A
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
232 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • BehavioralLethal Means Counseling

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

  • BehavioralHealth and Stress Reduction

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

06

What researchers measure

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)

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

Secondary outcomes

  1. 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

    Time frame: This will be assessed immediately after the intervention at baseline

  2. Changes in Willingness to Seek Mental Health Care in the Future

    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

  3. 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

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

07

Study locations

1 site
  • University of Southern Mississippi
    Hattiesburg, Mississippi 30406, United States
08

References and documents

Publications

  • 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. PubMed 33351652 ↗

Individual participant data

Plan to share: No — 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2017 to primary completion in Jul 2020, 37 months.

Of 308 non-industry interventional studies with no phase under Suicide, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's 37 months is above that.

Counting every sponsor, half of 319 studies reached it within 30 months; a quarter within 15 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 13, 2017
First posted
Dec 15, 2017
StartActual
Jun 1, 2017
Primary completionActual
Jul 14, 2020
CompletionActual
Jul 14, 2020
Last update
May 20, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03375099
Lead sponsor
University of Southern Mississippi
Collaborators
University of Utah
Responsible party
Sponsor
First posted
Dec 15, 2017
Start date
Jun 1, 2017
Primary completion
Jul 14, 2020
Completion
Jul 14, 2020
Last update
May 20, 2021

Study contacts

Michael D Anestis, PhD
principal investigator · Rutgers University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion