Suicide PreventionCDA-2NCT07247916
Developing and Piloting an Implementation Strategy for a Brief, Motivational Interviewing-based Lethal Means Safety Counseling Intervention in Primary Care Settings
A study testing RAMP in people with Suicide Prevention, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide Prevention
- What is being tested?
- RAMP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2027to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
Kimberly L Selander, MA, 203-932-5711, Kimberly.Selander@va.gov
Steve Martino, PhD, (203) 932-5711 ext. 2468, Steve.Martino@va.gov
About this study
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.
Read the 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.
- Conditions
- Suicide Prevention
- Being tested
- RAMP, Active control
- Keywords
- suicide, firearm, primary care, lethal means safety, motivational interviewing, self-injurious behavior
- Medical subject headings
- Suicide Prevention, Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAMPBehavioural
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 controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: RAMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, approximately 2 years
Recruitment
Investigators will track the number of eligible Veterans who enrolled in the study per month
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: at 50% enrollment (approximately 1 year) and 100% enrollment (approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Jul 2027 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Frances Aunon, PhD MS, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247916
- Sponsor's protocol ID
- HSR4-001-24W
- Other IDs
- 1IK2RD000503-01A2
- Acronym
- CDA-2
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Piloting an Implementation Strategy for a Brief, Motivational Interviewing-based Lethal Means Safety Counseling Intervention in Primary Care Settings
- ClinicalTrials.gov ID
- NCT07247916
- Acronym / sponsor ID
- CDA-2 / HSR4-001-24W
- Conditions
- Suicide Prevention
- Keywords
- suicide, firearm, primary care, lethal means safety, motivational interviewing, self-injurious behavior
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active control | Active comparator | Behavioral: Active controlThe 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. |
| RAMP | Experimental | Behavioral: RAMPParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has access to a firearm
- Referred to PCMHI care
- deliver care in PCMHI
- trained in RAMP and study procedures
Key exclusion criteria (6 listed)
- 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
- Did not participate in training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAMPParticipants 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 | Behavioural | RAMP |
| Active controlThe 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. | Behavioural | Active control |
Primary outcome
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
Recruitment
Time frame: through study completion, approximately 2 years
Investigators will track the number of eligible Veterans who enrolled in the study per month
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.
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
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.
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.
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Suicide Prevention
Not yet recruitingPhase 1/2
Reducing Firearm Suicide Among Veterans: Evaluating the Effectiveness of Peer-Delivered Lethal Means Counseling
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Intravenous Ketamine for Acute Suicidal Crisis and Psychiatric Hospital Length of Stay
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Recruiting
Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis
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Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
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THRIVE: A Recovery-Focused Suicide Prevention Intervention in Crisis Stabilization Centers
Suicide
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frances Aunon, PhD MS principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAMP in people with Suicide Prevention, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frances Aunon, PhD MS ((203) 932-5711 ext. 7894, Frances.Aunon@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening (time frame: through study completion, approximately 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.