- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03375099
Comparison of Lethal Means Counseling and an Active Control Condition, With and Without Provision of Gun Locks
May 17, 2021 updated by: University of Southern Mississippi
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
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
232
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mississippi
-
Hattiesburg, Mississippi, United States, 30406
- University of Southern Mississippi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Affiliated with the National Guard
- Owns at least one personal firearm
- Speaks English fluently
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
Single session motivational interviewing based interaction aimed to reduce vulnerability to negative outcomes across four domains: sleep, diet, exercise, and stress.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Change will be assessed at 3- and 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
This will be assessed immediately after the intervention at baseline
|
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
|
Change will be assessed immediately after the intervention and at 3- and 6-month follow-up
|
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
|
Change will be assessed immediately after the intervention and at 3- and 6-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michael D Anestis, PhD, Rutgers University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2017
Primary Completion (Actual)
July 14, 2020
Study Completion (Actual)
July 14, 2020
Study Registration Dates
First Submitted
November 13, 2017
First Submitted That Met QC Criteria
December 11, 2017
First Posted (Actual)
December 15, 2017
Study Record Updates
Last Update Posted (Actual)
May 20, 2021
Last Update Submitted That Met QC Criteria
May 17, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CH2-17022105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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