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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07247916
Acronym
CDA-2
Enrollment
50
Registered
2025-11-25
Start date
2027-07-01
Completion date
2031-12-31
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide Prevention

Keywords

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

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.

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.

Interventions

BEHAVIORALRAMP

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

BEHAVIORALActive 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

The research assistant (outcomes assessor) will be blinded to study condition.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Screeningthrough study completion, approximately 2 yearsInvestigators will assess the number of new PCMHI patients seen in PCMHI and the number who were approached about potential study participation per month
Recruitmentthrough study completion, approximately 2 yearsInvestigators will track the number of eligible Veterans who enrolled in the study per month
Retentionapproximately 30 daysInvestigators will calculate the number of Veterans who received RAMP who were willing to complete immediate and one-month follow up assessments.
Assessment of behavioral outcomesapproximately 30 daysInvestigators will assess the percentage of participants who completed behavioral outcome measures within the time allotted at each timepoint
Veteran acceptability - Theoretical Framework of AcceptabilityAt immediate follow up, within approximately 2 weeks of interventionInvestigators 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.
Veteran acceptability - Experience and Satisfaction with interventionAt immediate follow up, within approximately 2 weeks of interventionInvestigators will conduct qualitative evaluation of the participant's experience and satisfaction receiving the intervention.
Clinician acceptability - Theoretical Framework of Acceptabilityat 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.
Clinician acceptability - Negative impactat 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).

Countries

United States

Contacts

Primary ContactFrances Aunon, PhD MS
Frances.Aunon@va.gov(203) 932-5711
Backup ContactSteve Martino, PhD
Steve.Martino@va.gov(203) 932-5711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026