Lethal Means Safety Counseling for Suicide Prevention

(CDA-2 Trial)

Overseen By Steve Martino, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, Psychiatric symptoms, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: approximately 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to prevent suicide among veterans by exploring how counseling can reduce access to firearms, a common method of self-harm. It compares a new counseling approach called RAMP, which encourages safe firearm storage, to a standard pamphlet review on suicide prevention. Veterans who own firearms and are referred for specific mental health care may be suitable candidates for this trial. The goal is to determine if the new method is practical and helpful in a real-world setting. As an unphased trial, this study offers veterans the opportunity to contribute to innovative approaches in suicide prevention.

What prior data suggests that this counseling intervention is safe for Veterans?

Previous studies have shown that counseling on lethal means safety effectively reduces access to dangerous items like firearms. This counseling encourages safe behavior by tailoring advice to each person's needs. Participants generally find it easy to handle due to the counseling techniques used.

The RAMP (Raise the subject, Assess current storage, Motivate change, and Plan next steps) program employs these counseling methods. It aims to encourage secure firearm storage, thereby lowering the risk of suicide. This approach is based on motivational interviewing, a common healthcare technique that is generally safe and has few side effects.

Although specific safety data on RAMP is unavailable, the program poses minimal safety concerns because it is non-invasive. It involves discussions and planning rather than medical procedures or medications. Participants can be assured that the focus is on safety and prevention without any physical risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RAMP intervention for suicide prevention because it offers a personalized approach focused on secure firearm storage, a critical factor in reducing suicide risk. Unlike standard options that may include general counseling or distribution of informational pamphlets, RAMP uses motivational interviewing to actively engage participants in discussions about their current firearm storage practices and encourages them to plan concrete next steps for safer storage. This method not only addresses the behavioral aspect of suicide prevention but also empowers individuals to make immediate and meaningful changes in their environment.

What evidence suggests that this trial's treatments could be effective for suicide prevention?

Research has shown that counseling on lethal means safety (LMS) can lower the risk of suicide by guiding individuals to limit access to dangerous items like guns. Previous studies found that a similar method, called suicide safety planning, effectively reduces suicide attempts and thoughts. In this trial, participants may receive the RAMP method—Raise the subject, Assess current storage, Motivate change, and Plan next steps—which uses motivational interviewing to promote safer gun storage. This method is based on proven practices that support secure firearm storage, helping to reduce the risk of suicide. Although specific data on RAMP's effectiveness is limited, it builds on well-established strategies that have succeeded in the past. ^{3 6 7 8 9}

Who Is on the Research Team?

Frances Aunon, PhD MS

Principal Investigator

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Are You a Good Fit for This Trial?

This trial is for Veterans with an elevated risk of suicide, focusing on those who may have access to firearms or other lethal means. The goal is to test a counseling intervention that aims to reduce the likelihood of self-harm by promoting safety measures.

Inclusion Criteria

I provide care in a primary care mental health integration setting.

For clinicians (delivering intervention): Trained in RAMP and study procedures

For Veterans: Has access to a firearm

Exclusion Criteria

For Veterans: Unable to consent due to cognitive impairment, severity of illness (including psychiatric symptoms), intoxication with drugs and/or alcohol

For Veterans: Unreliable telephone access

For Veterans: Inability to read English or communicate in spoken and written English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

through study completion, approximately 2 years

Treatment

Participants receive either a brief, motivational interviewing-based intervention called RAMP or an active control condition involving a 5-minute review of a suicide prevention pamphlet

approximately 2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including immediate and one-month follow-up assessments

approximately 30 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Active control
• RAMP

Trial Overview The study compares two approaches: RAMP—a motivational interviewing-based LMS counseling—and an active control condition. It's designed to see which method is more feasible and acceptable in primary care settings for suicide prevention among Veterans.

How Is the Trial Designed?

Group I: RAMP Experimental Treatment 1 Intervention

Participants randomized to the intervention condition will receive a brief, motivational interviewing-based intervention called RAMP (Raise the subject, Assess current storage, Motivate change, and Plan next steps) in the context of their clinical care. RAMP incorporates evidence-informed intervention components to facilitate secure firearm storage

Group II: Active control Active Control 1 Intervention

The control condition will entail a 5-minute review of a pamphlet on suicide prevention with the PCMHI clinician. This pamphlet is produced by the Veteran's Crisis Line and is widely available on the OSP suicide prevention website as a VHA resource. This condition will control for time and attention, subject matter, mode of delivery, and setting.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07247916?lastUpdPost=2020-01-10_

Study Details | NCT07247916 | Developing and Piloting an ... This is a pilot randomized controlled trial of up to 50 Veterans to assess the feasibility and acceptability of a LMS intervention and testing ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10189833/

Effectiveness of Suicide Safety Planning Interventions Evidence across a range of studies indicates that SSP is effective for reducing suicide behavior (SB) and ideation (SI).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12203803/

Development of a peer-delivered lethal means counseling ... This study aimed to adapt and expand an evidence-based lethal means counseling intervention for peer-delivery among firearm owning Veterans.

4. mirecc.va.gov mirecc.va.gov/lethalmeanssafety/

Lethal Means Safety and Suicide Prevention Lethal Means Safety (LMS) is an intentional, voluntary practice to reduce one's suicide risk by limiting access to lethal means.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2949732924000966

Developing and Piloting Suicide Prevention Training in ... This article describes a first step in community-participatory development and pilot evaluation of a suicide prevention training series for PPCCs.

6. mirecc.va.gov mirecc.va.gov/visn19/lethalmeanssafety/counseling/

Lethal Means Safety Counseling Lethal Means Safety Counseling (LMSC) is a patient-centered counseling strategy that aims to promote safety behaviors by aligning evidence-based recommendations ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12395793/

Multidisciplinary lethal means safety counseling design ... Lethal means safety counseling (LMSC) is a recommended suicide prevention strategy that restricts access to commonly used lethal means [11–13] ...

8. sprc.org sprc.org/resources/calm-counseling-on-access-to-lethal-means/

CALM: Counseling on Access to Lethal Means CALM is a free online course focused on reducing access to lethal means, like firearms and medication, to prevent suicide. It is primarily for mental health ...

9. hhs.gov hhs.gov/sites/default/files/nnsp-federal-action-plan.pdf

National Strategy for Suicide Prevention Federal Action Plan Increase timely access to assessment, intervention, lethal means safety counseling, and follow-up for people at risk of suicide along the crisis ...