Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1IK2RD000503-01A2 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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. |
Not provided
Not provided
Inclusion Criteria:
For Veterans:
For clinicians (delivering intervention):
Exclusion Criteria:
For Veterans:
For clinicians (delivering intervention):
- Did not participate in training
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frances Aunon, PhD MS | Contact | (203) 932-5711 | 7894 | Frances.Aunon@va.gov |
| Steve Martino, PhD | Contact | (203) 932-5711 | 2468 | Steve.Martino@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Frances Aunon, PhD MS | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516-2770 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
The research assistant (outcomes assessor) will be blinded to study condition.
|
| 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. |
|
| 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) |
| ID | Term |
|---|---|
| D000092864 | Suicide Prevention |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D001107 | Architectural Accessibility |
| ID | Term |
|---|---|
| D005160 | Facility Design and Construction |
| D001108 | Architecture |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided