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NCT03272048
Identifying Effective Approaches to Counseling on Firearm Safety
NA trial testing Lethal Means Counseling in Suicide in 96 participants. Completed in 2 April 2018.
2 April 2018
Quick facts
| Lead sponsor | Florida State University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 96 |
| Start date | 6 September 2017 |
| Primary completion | 2 April 2018 |
| Estimated completion | 2 April 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Lethal Means Counseling
Conditions studied
- Suicide — all drugs for Suicide →
Sponsor
Florida State University
Who can join
18 and older, any sex, with Suicide. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Each year in the United States (U.S.), over 40,000 individuals die by suicide, and approximately half of these deaths occur by intentional, self-inflicted gunshot wounds. Given these staggering statistics, efforts to minimize individuals' access to firearms during at-risk periods has been identified as a critical if fraught suicide prevention strategy. Among individuals at risk for suicide who present to clinical settings, a crucial component of the clinical management of suicide risk is to ask about firearm ownership/access and counsel on firearm safety (e.g., encourage an at-risk person to transfer the firearm to a loved one until risk abates). Despite the clinical, ethical, and in some cases legal mandate of this intervention, a substantial proportion of clinicians are woefully undertrained and therefore unprepared to manage suicide risk and appropriately deliver counseling on firearm safety. Clinical and empirical evidence suggests that even among patients identified to be at increased risk for suicide, few clinicians ask about firearms or provide counseling on firearm safety. One key reason for this fissure between recommendations and actual implementation of recommendations is that strategies for discussing firearm safety in a way that is impactful and yields patient adherence to recommendations have yet to be established. One common approach to attempt to garner pro-health behavior change is the use of fear appeals; however, research on the utility of this approach across non-firearm-related health interventions has been equivocal. Given the cultural importance placed on firearms in the U.S., the investigators contend that fear-based approaches to lethal means counseling may be counter-productive by creating defensive avoidance, thereby detracting from the purpose of counseling on firearm safety (i.e., patient safety). Further, patient adherence to recommendations to limit access to a firearm during at-risk periods may be increased when clinicians emphasize that limits on firearm access will decline when suicide risk abates (i.e., limits on firearm access will likely not be permanent). However, research has yet to determine if varying the level of fear messaging and/or emphasis on temporariness is actually useful and acceptable. To address this gap, the investigators will randomly assign participants to one of four experimental conditions: (1) low-fear/not-temporary; (2) low-fear/temporary; (3) high-fear/not-temporary; and (4) high-fear/temporary. Participants include undergraduate students who are vulnerable to suicide and reported owning or previously owning a firearm, reported access to a firearm, or reported possibly obtaining a firearm in the future. The investigators hypothesized that individuals randomly assigned to the low-fear/temporary group will (1) report greater intentions to adhere to recommendations to limit access to firearms during at-risk periods than the other groups at both post-intervention and one-month follow-up; (2) report greater actual adherence to recommendations at one-month follow-up; and (3) rate the lethal means counseling session as more acceptable than the other groups. Exploratory aims examined if the effects differed for individuals reporting actual current firearm ownership or access, membership in the National Rifle Association (NRA) or a similar organization, political affiliation, political ideology, greater personal importance of the Second Amendment, or severity of suicidal symptoms. Findings have the potential to inform clinical and public health approaches to limit at-risk individuals' access to firearms for safety purposes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03272048
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Lethal Means Counseling
Trials testing the same drug.
- NCT03835585 — Gun Locks in Firearm Suicide Intervention · NA · completed
- NCT03375099 — Comparison of Lethal Means Counseling and an Active Control Condition, With and Without Provision of Gun Locks · NA · completed
Other recruiting trials for Suicide
Currently open trials in the same condition.
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- NCT07214233 — Youth Empowerment and Safety Intervention · NA · recruiting
- NCT07343258 — Pilot Study on Follow-Up of (Acutely) Suicidal Individuals From the Flemish Suicide Helpline · NA · recruiting
- NCT07523490 — Investigation on Suicide Risk Factors of Patients With Mood Disorders · recruiting
- NCT06571916 — Brief Skills for Safer Living (Brief-SfSL) · NA · recruiting
Other Florida State University trials
Trials by the same sponsor.
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- NCT06015581 — Scaling Up Implementation Strategies to Improve the DIAGNOSE and PREVENT Pillars for Young MSM in Florida · NA · not yet recruiting
- NCT07467473 — Causal Role of Rostromedial Prefrontal Cortex for Positive Savoring in Depression · NA · enrolling by invitation
- NCT07221448 — Sodium vs Potassium Education to Improve Vascular Health · NA · recruiting
- NCT07415941 — MBM and taVNS for Low Back Pain and Depressive Symptoms · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03272048 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Florida State University
- Last refreshed: 11 September 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03272048.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing