Developing and Piloting an Implementation Strategy for a Brief, Motivational Interviewing-based Lethal Means Safety Counseling Intervention in Primary Care Settings (CDA-2)

November 20, 2025 updated by: VA Office of Research and Development
Suicide prevention remains a significant priority and nearly three-quarters of Veteran suicides result from firearm injury. Since access to lethal means of self-harm increases the risk of injury, the VA/DoD Clinical Practice Guidelines recommend that Veterans with elevated suicide risk receive lethal means safety (LMS) counseling to reduce access to lethal means, including firearms. However, no LMS counseling interventions have been tested within VA. Thus, the aim of this study is to conduct a pilot randomized controlled trial to evaluate the feasibility and acceptability of a tailored LMS counseling intervention compared to an active control condition.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a pilot randomized controlled trial of up to 50 Veterans to assess the feasibility and acceptability of a LMS intervention and testing procedures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516-2770
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
        • Contact:
        • Contact:
        • Principal Investigator:
          • Frances Aunon, PhD MS

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

For Veterans:

  • Has access to a firearm
  • Referred to PCMHI care

For clinicians (delivering intervention):

  • deliver care in PCMHI
  • trained in RAMP and study procedures

Exclusion Criteria:

For Veterans:

  • Unable to consent due to cognitive impairment, severity of illness (including psychiatric symptoms), intoxication with drugs and/or alcohol
  • Unreliable telephone access
  • Inability to read English or communicate in spoken and written English

For clinicians (delivering intervention):

- Did not participate in training

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active control
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.
Behavioral: Active control
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.
Experimental: RAMP
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
Behavioral: RAMP
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Screening
Time Frame: through study completion, approximately 2 years
Investigators will assess the number of new PCMHI patients seen in PCMHI and the number who were approached about potential study participation per month
through study completion, approximately 2 years
Recruitment
Time Frame: through study completion, approximately 2 years
Investigators will track the number of eligible Veterans who enrolled in the study per month
through study completion, approximately 2 years
Retention
Time Frame: approximately 30 days
Investigators will calculate the number of Veterans who received RAMP who were willing to complete immediate and one-month follow up assessments.
approximately 30 days
Assessment of behavioral outcomes
Time Frame: approximately 30 days
Investigators will assess the percentage of participants who completed behavioral outcome measures within the time allotted at each timepoint
approximately 30 days
Veteran acceptability - Theoretical Framework of Acceptability
Time Frame: At immediate follow up, within approximately 2 weeks of intervention
Investigators will assess Veteran acceptability using the eight Likert-style items from the Theoretical Framework of Acceptability questionnaire, which assess seven component constructs of acceptability including Veteran's experience of the lethal means safety intervention. Each item has 5 answer options (1-5) on a Likert Scale. Score range is 8 to 40, with a higher score indicating more higher reported acceptability.
At immediate follow up, within approximately 2 weeks of intervention
Veteran acceptability - Experience and Satisfaction with intervention
Time Frame: At immediate follow up, within approximately 2 weeks of intervention
Investigators will conduct qualitative evaluation of the participant's experience and satisfaction receiving the intervention.
At immediate follow up, within approximately 2 weeks of intervention
Clinician acceptability - Theoretical Framework of Acceptability
Time Frame: at 50% enrollment (approximately 1 year) and 100% enrollment (approximately 2 years)
Investigators will invite clinicians to respond to the eight-item Theoretical Framework of Acceptability questionnaire eliciting clinician acceptability of the lethal means safety intervention. Each item has 5 answer options (1-5) on a Likert Scale. Score range is 8 to 40, with a higher score indicating more higher reported acceptability.
at 50% enrollment (approximately 1 year) and 100% enrollment (approximately 2 years)
Clinician acceptability - Negative impact
Time Frame: at 50% enrollment (approximately 1 year) and 100% enrollment (approximately 2 years)
Investigators will assess to what extent PCMHI clinicians agree that study recruitment negatively impacted clinical care, using Likert-type items where '1' indicates "strongly disagree" and '5' indicates "strongly agree." For those responding >3 ("don't know"), an open-ended question will elicit detailed information (e.g., interfered with delivery of clinical care, led to Veteran frustration).
at 50% enrollment (approximately 1 year) and 100% enrollment (approximately 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frances Aunon, PhD MS, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSR4-001-24W
  • 1IK2RD000503-01A2%9 (Other Grant/Funding Number: VA Office of Research & Development)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings