NCT07033884

Brief Summary

Suicide prevention is a top priority for the Department of Veterans Affairs (VA), with a major emphasis on developing innovative and effective ways to prevent firearm suicide. Research suggests that secure firearm storage can decrease risk for suicide and the current project aims to evaluate a novel approach to increasing secure storage through an experimental design. The intervention takes one-hour or less and involves a peer-to-peer discussion about secure firearm storage, focusing on participants' reasons for and against using more secure firearm storage practices. The project will evaluate whether Veterans who receive this intervention report greater use of secure firearm storage practices than Veterans who receive only psychoeducational materials on this topic. Secure firearm storage practices will be evaluated over the course of one year. It is hypothesized that Veterans who engage in the peer-to-peer intervention will report greater use of secure firearm storage practices than those who receive only psychoeducational materials. Relevant to Veterans' health, secure firearm storage decreases Veteran firearm suicide risk and may help prevent suicide. In addition, this peer-delivered intervention is preferred by Veterans, and has the flexibility to be implemented before suicide risk develops and in settings outside of the VA. This means the intervention has the potential to reach more Veterans, even those who do not receive VA healthcare.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
52mo left

Started Jul 2026

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
1 year until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2029

1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2030

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

June 9, 2025

Last Update Submit

March 10, 2026

Conditions

Keywords

Suicide PreventionFirearmsMotivational Interviewing

Outcome Measures

Primary Outcomes (4)

  • Modified MIRECC Lethal Means Questionnaire

    The MIRECC Lethal Means Questionnaire (Simonetti, 2017) is a 13-item self-report measure designed to assess experiences with firearms. Items include questions about number and type of firearms owned, primary reason for firearm ownership, and firearm handling. It also includes items related to firearm storage practices. Two open-ended questions were also added to allow participants to describe, in their own words, their current firearm storage practices, and at follow-ups to describe any changes they've made to their firearm storage that is not captured in the other questions. Responses to three key firearm storage items will be totaled to create a composite storage score, with higher scores indicating safer storage practices. Range of values: 0-6.

    Eligibility Screening, Baseline, Follow-ups (1-week, 6-months, 1-year)

  • Theory of Planned Behavior

    A 15-item measure was designed using Francis and colleagues' (2004) guide to assess each of the four subdomains of the Theory of Planned Behavior. Specifically, there are three items assessing intentions to increase secure firearm storage (e.g., "I intend to increase my use of secure firearm storage"), four items assessing attitudes towards increasing secure firearm storage, four items assessing subjective norms surrounding increasing secure firearm storage (e.g., "People who are important to me want me to increase my use of secure firearm storage"), and four items assessing perceived behavioral control of increasing secure firearm storage. All items include 7-point Likert scale response options and the items within subdomains (e.g., intentions, attitudes) are averaged to produce overall subdomain scores. Range of values: 1-7.

    Baseline and Follow-ups (1-week, 6-months, 1-year)

  • Beliefs and Attitudes about Firearms and Suicide

    A 3-item questionnaire used to evaluate belief in relationships related to suicide risk. Items include, "To what extent do you think owning a firearm is related to suicide risk?", "To what extent do you think how a firearm is stored (e.g., gun safe, loaded) is related to suicide risk?", and "To what extent do you agree with the statement 'if somebody wants to die by suicide and you prevent them from using a specific method, they will simply find another way to die'?" Participants will respond on a 5-point Likert scale, with higher scores indicating higher belief in the statement or described relationship. Range of values: 0-12.

    Baseline and Follow-ups (1-week, 6-months, 1-year)

  • Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

    PTSD symptoms will be assessed using the PCL-5, including the criterion A face page (Blevins et al., 2015). The PCL-5 includes a brief set of questions assessing whether an individual has experienced a criterion A stressor, followed by a 20-item self-report questionnaire designed to assess each of the 20 Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) PTSD symptoms. Participants will first be asked to respond to five questions on the face page assessing for criterion A stressors. Next, they will be asked to respond to the 20-item self-report measure using a 5-point Likert scale, with higher scores suggesting higher symptom severity. In addition to a total score, the PCL-5 yields four subscale scores reflecting the four PTSD symptom clusters (i.e., re-experiencing, avoidance, alteration in cognitions and mood, and arousal and reactivity). Range of values: 0-80.

    Baseline and Follow-ups (1-week, 6-months, 1-year)

Secondary Outcomes (1)

  • Semi-Structured Interview

    Post 1-year Follow-up

Study Arms (2)

PEERS

EXPERIMENTAL

Veterans in this condition will complete the PEERS intervention and will receive the same psychoeducational materials as the active control group.

Behavioral: Peer Engagement and Exploration of Responsibility and Safety

Active Control

OTHER

Veterans in this condition will receive psychoeducational materials on lethal means safety and will have NO interaction with peers.

Other: Active Control

Interventions

PEERS involves a one-on-one session with a firearm-owning Veteran peer interventionist. The appointment will last between 15 minutes and one hour, and the modality (i.e., in-person or virtual) will be based on Veteran participant preference. Principal components of the PEERS session will include: 1) engaging - initiating conversation in a non-confrontational manner; 2) focusing - quickly concentrating the discussion on the topic of firearms and means safety; 3) evoking - reflecting the participants' reasons both for and against engaging in means safety, leveraging the participants' own rationale for change as a tool for increasing behavior change; and 4) planning - once a plan is agreed upon, this information is put into writing. Participants will also be provided the same psychoeducational materials provided to the participants in the active control condition.

Also known as: PEERS
PEERS

Veterans will receive no treatment and will not interact with peers. A no treatment control condition was selected due to the preventative nature of PEERS, as well as the early stage of evaluation for this intervention. However, given the varied recruitment outlets and subsequent lack of standardized "usual care," as well as ethical concerns with not providing important resources to firearm owning Veterans, two informational handouts will be added to this control condition. Specifically, Veterans in this condition will be provided with an informational handout developed by the National Sports Shooting Foundation, which includes a variety of secure firearm storage options, as well as a handout listing national mental health and suicide prevention resources.

Also known as: AC
Active Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran
  • Owns at least one personal firearm
  • Displays some level of unsecure firearm storage (i.e., scores \< 6 on MIRECC Lethal Means Questionnaire eligibility screener)
  • Capable of meeting via virtual modalities for appointments (i.e., owns a device capable of connecting for virtual appointments, has internet access)

You may not qualify if:

  • Active psychosis
  • Insufficient English language skills
  • No reliable access to a telephone and/or device for attending appointments via virtual modalities
  • Prior participation in the PI's CDA-1 study (N = 16)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southeast Louisiana Veterans Health Care System, New Orleans, LA

New Orleans, Louisiana, 70119, United States

Location

MeSH Terms

Conditions

SuicideSuicide Prevention

Interventions

Safety

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Accident PreventionAccidentsPublic HealthEnvironment and Public Health

Study Officials

  • Claire Houtsma, PhD

    Southeast Louisiana Veterans Health Care System, New Orleans, LA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Houtsma, PhD

CONTACT

Amanda M Raines, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are randomized (1:1) upon enrollment to one of two conditions.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2025

First Posted

June 24, 2025

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

May 31, 2029

Study Completion (Estimated)

September 30, 2030

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations