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NCT Number: NCT07247916

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

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.

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Key information

Conditions

Suicide Prevention Behavior Behavioral Symptoms Self-Injurious Behavior Suicide

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

West Haven, Connecticut, 06516-2770, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. 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

  2. Recruitment

    Time frame: through study completion, approximately 2 years

    Investigators will track the number of eligible Veterans who enrolled in the study per month

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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).

Interested in participating?

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Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: CDA-2

Important dates

Study start
2027
Primary completion
2029
Study completion
2031
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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