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

NCT07247916 | Not Yet Recruiting

• 2 other identifiers: HSR4-001-24W1IK2RD000503-01A2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Suicide Prevention

Keywords

suicide; firearm; primary care; lethal means safety; motivational interviewing; self-injurious behavior

Outcome Measures

Primary Outcomes (8)

• 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)

Study Arms (2)

Active control

ACTIVE COMPARATOR

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

RAMP

EXPERIMENTAL

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

Interventions

RAMP BEHAVIORAL

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

RAMP

Active control BEHAVIORAL

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.

Active control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

West Haven, Connecticut, 06516-2770, United States

Location

MeSH Terms

Conditions

Suicide Prevention; Suicide; Self-Injurious Behavior

Interventions

Architectural Accessibility

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Facility Design and Construction; Architecture; Technology, Industry, and Agriculture

Study Officials

• Frances Aunon, PhD MS

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frances Aunon, PhD MS

CONTACT

(203) 932-5711; Frances.Aunon@va.gov

Steve Martino, PhD

CONTACT

(203) 932-5711; Steve.Martino@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research assistant (outcomes assessor) will be blinded to study condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This pilot randomized controlled trial includes two arms: the experimental arm will have trained PCMHI clinicians deliver a brief motivational interviewing-based intervention to facilitate secure firearm storage; the control arm will have PCMHI clinicians review a suicide prevention pamphlet.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 25, 2025
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)