SuicidePhase 1/2NCT07033884
Reducing Firearm Suicide Among Veterans: Evaluating the Effectiveness of Peer-Delivered Lethal Means Counseling
A Phase 1/2 study testing Peer Engagement and Exploration of Responsibility and Safety in people with Suicide and Secure Firearm Storage, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide, Secure Firearm Storage
- What is being tested?
- Peer Engagement and Exploration of Responsibility and Safety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to 30 Sep 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veteran
- Owns at least one personal firearm
- Displays some level of unsecure firearm storage (i.e., scores < 6 on Mental Illness Research, Education, and Clinical Center (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)
Who cannot join
- 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 Principal Investigator's CDA-1 study (N = 16)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Southeast Louisiana Veterans Health Care System, New Orleans, LA
New Orleans, Louisiana, 70119
Claire Houtsma, PhD, (504) 507-2000 ext. 66003, claire.houtsma@va.gov
R. Brooks Robey, MD, (504) 507-7331, brooks.robey@va.gov
About this study
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.
Read the detailed description
Veterans die by suicide at a rate 1.72 times greater than civilian counterparts. Notably, 72% of Veteran suicides result from a firearm, making firearm suicide prevention a leading priority for the Department of Veterans Affairs (VA). Secure firearm storage (e.g., unloaded, locked) mitigates risk of firearm suicide, but these practices are uncommon among firearm owning Veterans. Lethal means counseling (LMC), an intervention that promotes reduced access to potentially lethal suicide methods (e.g., firearms) through one-on-one interactions, is a promising approach to promoting secure firearm storage among Veterans. However, there are limitations to the reach and acceptability of LMC among firearm owning Veterans within VA, including healthcare providers' limited time during appointments and firearm owners' stated preference to discuss firearms with those perceived to be credible, such as fellow Veterans. As a result, most Veteran firearm owners, including those with recent suicidal ideation, report that they have not discussed firearm access with their healthcare providers. It is crucial to expand LMC efforts to non-clinician messengers to reach more Veterans. What remains unknown is how effective preferred messengers are in changing firearm storage behaviors, as well as what mechanisms impact or account for subsequent changes in firearm storage behaviors. Thus, there is a critical need to evaluate the effectiveness of peer-delivered LMC among Veteran firearm owners. Without such knowledge, preventing suicide within this population will likely remain difficult.
The overall objective of the current study is to estimate the effectiveness, as well as factors that impact or account for the effectiveness, of peer-delivered LMC. My central hypothesis is that peer-delivered LMC will lead to greater use of secure firearm storage and this will be accounted for and influenced by mechanisms conceptualized by the Theory of Planned Behavior (TPB), those proposed to be relevant in prior research, and unique mechanisms that have yet to be identified. This hypothesis was formulated on the basis of preliminary data generated through a Clinical Sciences Research and Development Career Development Award-1. During that study, I adapted a healthcare provider-delivered LMC intervention, found to increase secure firearm storage among National Guard members, for peer-delivery through an expert panel. The resulting intervention, Peer Engagement and Exploration of Responsibility and Safety (PEERS), is a 15-60 minute one-on-one LMC session centered around Motivational Interviewing principles and delivered by Veterans. In a single arm pilot trial, PEERS was feasible and acceptable among Veteran firearm owners. Thus, the rationale for this project is to determine the effectiveness, as well as mechanisms that impact or account for the effectiveness, of PEERS, providing new opportunities for suicide prevention among Veteran firearm owners. Two specific aims are proposed:
- Estimate the superiority of PEERS compared to a psychoeducation control condition on secure firearm storage in a randomized controlled trial (N = 100; 1:1). My working hypothesis is Veterans receiving PEERS will demonstrate greater use of secure firearm storage than Veterans in the psychoeducation condition.
- Identify indirect (2a \& 2c) and moderating (2b \& 2c) effects of the relationship between PEERS and secure firearm storage. My working hypothesis, based on the TPB, is that changes in secure firearm storage will be indirect through attitudes towards secure firearm storage, subjective norms about secure firearm storage, perceived ease of changing firearm storage, and intentions to change firearm storage (2a). I further hypothesize, based on prior research, that primary motivation for ownership (personal/family protection), Posttraumatic Stress Disorder hyperarousal symptoms, and low belief in the relationship between firearms and suicide risk, will attenuate changes in secure firearm storage (2b). To identify other factors that may influence the relationship between PEERS and secure firearm storage, I will recruit up to 24 Veterans who participated in PEERS for individual qualitative interviews regarding barriers and facilitators to engagement in the intervention (2c).
- Conditions
- Suicide, Secure Firearm Storage
- Being tested
- Peer Engagement and Exploration of Responsibility and Safety, Active Control
- Keywords
- Suicide Prevention, Firearms, Motivational Interviewing
- Medical subject headings
- Suicide, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Engagement and Exploration of Responsibility and SafetyBehavioural
Also called PEERS
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.
Active ControlOther
Also called AC
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.
| Study group | Role | What they receive |
|---|---|---|
| PEERS | Experimental | Veterans in this condition will complete the PEERS intervention and will receive the same psychoeducational materials as the active control group. Receives: 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. Receives: Other: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Mental Illness Research, Education, and Clinical Center (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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Follow-ups (1-week, 6-months, 1-year)
Secondary outcomes (1)
Semi-Structured Interview
Qualitative feedback on barriers and facilitators to engagement in PEERS will be obtained through audio-recorded semi-structured interviews with up to 24 Veterans who were randomized to the PEERS condition. In addition to self-generated barriers and facilitators to engagement in PEERS, Veterans will be asked to identify non-VHA settings in which they may prefer to receive such an intervention. The semi-structured interview template was adapted from Dobscha et al., 2021.
Measured: Post 1-year Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Feb 2027 (estimated)
- Primary completion31 May 2029 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized (1:1) upon enrollment to one of two conditions.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Claire Houtsma, PhD, Principal investigator, Southeast Louisiana Veterans Health Care System, New Orleans, LA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033884
- Sponsor's protocol ID
- MHBC-003-24F
- Other IDs
- 1IK2CX002877-01A1
- Status last verified
- Oct 2026
- First submitted
- 9 Jun 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Firearm Suicide Among Veterans: Evaluating the Effectiveness of Peer-Delivered Lethal Means Counseling
- ClinicalTrials.gov ID
- NCT07033884
- Acronym / sponsor ID
- MHBC-003-24F
- Conditions
- Suicide, Secure Firearm Storage
- Keywords
- Suicide Prevention, Firearms, Motivational Interviewing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Veterans die by suicide at a rate 1.72 times greater than civilian counterparts. Notably, 72% of Veteran suicides result from a firearm, making firearm suicide prevention a leading priority for the Department of Veterans Affairs (VA). Secure firearm storage (e.g., unloaded, locked) mitigates risk of firearm suicide, but these practices are uncommon among firearm owning Veterans. Lethal means counseling (LMC), an intervention that promotes reduced access to potentially lethal suicide methods (e.g., firearms) through one-on-one interactions, is a promising approach to promoting secure firearm storage among Veterans. However, there are limitations to the reach and acceptability of LMC among firearm owning Veterans within VA, including healthcare providers' limited time during appointments and firearm owners' stated preference to discuss firearms with those perceived to be credible, such as fellow Veterans. As a result, most Veteran firearm owners, including those with recent suicidal ideation, report that they have not discussed firearm access with their healthcare providers. It is crucial to expand LMC efforts to non-clinician messengers to reach more Veterans. What remains unknown is how effective preferred messengers are in changing firearm storage behaviors, as well as what mechanisms impact or account for subsequent changes in firearm storage behaviors. Thus, there is a critical need to evaluate the effectiveness of peer-delivered LMC among Veteran firearm owners. Without such knowledge, preventing suicide within this population will likely remain difficult.
The overall objective of the current study is to estimate the effectiveness, as well as factors that impact or account for the effectiveness, of peer-delivered LMC. My central hypothesis is that peer-delivered LMC will lead to greater use of secure firearm storage and this will be accounted for and influenced by mechanisms conceptualized by the Theory of Planned Behavior (TPB), those proposed to be relevant in prior research, and unique mechanisms that have yet to be identified. This hypothesis was formulated on the basis of preliminary data generated through a Clinical Sciences Research and Development Career Development Award-1. During that study, I adapted a healthcare provider-delivered LMC intervention, found to increase secure firearm storage among National Guard members, for peer-delivery through an expert panel. The resulting intervention, Peer Engagement and Exploration of Responsibility and Safety (PEERS), is a 15-60 minute one-on-one LMC session centered around Motivational Interviewing principles and delivered by Veterans. In a single arm pilot trial, PEERS was feasible and acceptable among Veteran firearm owners. Thus, the rationale for this project is to determine the effectiveness, as well as mechanisms that impact or account for the effectiveness, of PEERS, providing new opportunities for suicide prevention among Veteran firearm owners. Two specific aims are proposed:
- Estimate the superiority of PEERS compared to a psychoeducation control condition on secure firearm storage in a randomized controlled trial (N = 100; 1:1). My working hypothesis is Veterans receiving PEERS will demonstrate greater use of secure firearm storage than Veterans in the psychoeducation condition.
- Identify indirect (2a \& 2c) and moderating (2b \& 2c) effects of the relationship between PEERS and secure firearm storage. My working hypothesis, based on the TPB, is that changes in secure firearm storage will be indirect through attitudes towards secure firearm storage, subjective norms about secure firearm storage, perceived ease of changing firearm storage, and intentions to change firearm storage (2a). I further hypothesize, based on prior research, that primary motivation for ownership (personal/family protection), Posttraumatic Stress Disorder hyperarousal symptoms, and low belief in the relationship between firearms and suicide risk, will attenuate changes in secure firearm storage (2b). To identify other factors that may influence the relationship between PEERS and secure firearm storage, I will recruit up to 24 Veterans who participated in PEERS for individual qualitative interviews regarding barriers and facilitators to engagement in the intervention (2c).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized (1:1) upon enrollment to one of two conditions.
| Arm | Type | Receives |
|---|---|---|
| PEERS | Experimental | Behavioral: Peer Engagement and Exploration of Responsibility and SafetyVeterans in this condition will complete the PEERS intervention and will receive the same psychoeducational materials as the active control group. |
| Active Control | Other | Other: Active ControlVeterans in this condition will receive psychoeducational materials on lethal means safety and will have NO interaction with peers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veteran
- Owns at least one personal firearm
- Displays some level of unsecure firearm storage (i.e., scores < 6 on Mental Illness Research, Education, and Clinical Center (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)
Key exclusion criteria (4 listed)
- 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 Principal Investigator's CDA-1 study (N = 16)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Engagement and Exploration of Responsibility and SafetyAlso: PEERSPEERS 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. | Behavioural | PEERS |
| Active ControlAlso: ACVeterans 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. | Other | Active Control |
Primary outcome
Modified Mental Illness Research, Education, and Clinical Center (MIRECC) Lethal Means Questionnaire
Time frame: Eligibility Screening, Baseline, Follow-ups (1-week, 6-months, 1-year)
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.
Theory of Planned Behavior
Time frame: Baseline and Follow-ups (1-week, 6-months, 1-year)
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.
Beliefs and Attitudes about Firearms and Suicide
Time frame: Baseline and Follow-ups (1-week, 6-months, 1-year)
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.
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: Baseline and Follow-ups (1-week, 6-months, 1-year)
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.
1 secondary outcome
Semi-Structured Interview
Time frame: Post 1-year Follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claire Houtsma, PhD principal investigator
Southeast Louisiana Veterans Health Care System, New Orleans, LA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Peer Engagement and Exploration of Responsibility and Safety in people with Suicide and Secure Firearm Storage, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire Houtsma, PhD ((504) 507-2000 ext. 66003, claire.houtsma@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Mental Illness Research, Education, and Clinical Center (MIRECC) Lethal Means Questionnaire (time frame: Eligibility Screening, Baseline, Follow-ups (1-week, 6-months, 1-year)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.