NCT Number: NCT07247916
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
West Haven, Connecticut, 06516-2770, United States
Frances Aunon, PhD MS
PRINCIPAL_INVESTIGATOR
Kimberly L Selander, MA
CONTACT
Steve Martino, PhD
CONTACT
(203) 932-5711 ext. 2468
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For Veterans:
For clinicians (delivering intervention):
Exclusion criteria
For Veterans:
For clinicians (delivering intervention):
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
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.
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
Time frame: through study completion, approximately 2 years
Investigators will track the number of eligible Veterans who enrolled in the study per month
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.
Time frame: approximately 30 days
Investigators will assess the percentage of participants who completed behavioral outcome measures within the time allotted at each timepoint
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.
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.
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.
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).
Contact information is provided by the study sponsor or research team.
Frances Aunon, PhD MS
CONTACT
(203) 932-5711 ext. 7894
Steve Martino, PhD
CONTACT
(203) 932-5711 ext. 2468
VA Office of Research and Development
Fed
Acronym: CDA-2
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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