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

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: Not yet recruiting
• Conditions: Suicide Prevention
• Intervention / Treatment: Behavioral: Active control; Behavioral: RAMP

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: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steve Martino, PhD; Phone Number: 2468 (203) 932-5711; Email: Steve.Martino@va.gov
• Study Contact Backup: Name: Frances Aunon, PhD MS; Phone Number: 7894 (203) 932-5711; Email: Frances.Aunon@va.gov

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516-2770
      • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
      • Contact: Steve Martino, PhD; Phone Number: 2468 (203) 932-5711; Email: Steve.Martino@va.gov
      • Contact: Kimberly L Selander, MA; Phone Number: 203-932-5711; Email: Kimberly.Selander@va.gov
      • Principal Investigator: Frances Aunon, PhD MS

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Screening	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	Investigators will track the number of eligible Veterans who enrolled in the study per month	through study completion, approximately 2 years
Retention	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	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	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	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	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	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

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Frances Aunon, PhD MS, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: primary care; suicide; motivational interviewing; self-injurious behavior; firearm; lethal means safety
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Suicide Prevention; Suicide; Self-Injurious Behavior; Technology, Industry, and Agriculture; Facility Design and Construction; Architecture; Architectural Accessibility
• Other Study ID 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