SuicideNCT03272048
Identifying Effective Approaches to Counseling on Firearm Safety
A study testing Lethal Means Counseling in people with Suicide, run by Florida State University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide
- What is being tested?
- Lethal Means Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2017to 2 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Lifetime history of suicidal ideation or a suicide attempt
- Firearm familiarity (based on participants' self-report that they currently own a firearm, previously owned a firearm, have access to a firearm, have a desire to obtain a firearm in the future, or intend to obtain a firearm in the future)
Who cannot join
- Younger than 18 years old
- Imminent risk of harm to self or others necessitating hospitalization
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University Department of Psychology
Tallahassee, Florida, 32304
About this study
Official title: Identifying Effective Approaches to Counseling on Firearm Safety: A Randomized Experimental Design Among Firearm-familiar Individuals at Risk for Suicide
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).
Read more
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.
- Conditions
- Suicide
- Being tested
- Lethal Means Counseling
- Keywords
- Firearms
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lethal Means CounselingBehavioural
Lethal means counseling is broadly defined as clinician-initiated discussions that encourage an individual at risk for suicide to safely store his or her firearms. Examples in this domain include applying a gun lock, separating the gun from its ammunition, dismantling the firearm and keeping its components locked and/or separated, or safely transferring the firearm to a trusted loved one, friend, or police station until risk abates (Bryan, Stone, \& Rudd, 2011; Jin, Khazem, \& Anestis, 2016). Further, given that recent purchasers of firearms are at markedly increased risk of death by suicide (Wintemute, Parham, Beaumont, Wright, \& Drake, 1999), anticipatory counseling on firearm safety should also be considered for at-risk individuals who do not report currently owning or having access to a firearm, but who report prior firearm ownership/access or intentions of obtaining a firearm in the future (Harvard T.H. Chan School of Public Health, 2017).
| Study group | Role | What they receive |
|---|---|---|
| Low-Fear/Not-Temporary | Experimental | Not described Receives: Behavioral: Lethal Means Counseling |
| Low-Fear/Temporary | Experimental | Not described Receives: Behavioral: Lethal Means Counseling |
| High-Fear/Not-Temporary | Experimental | Not described Receives: Behavioral: Lethal Means Counseling |
| High-Fear/Temporary | Experimental | Not described Receives: Behavioral: Lethal Means Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Intentions to Adhere to Clinician Recommendations Scale
Measured: Change from Pre-Intervention to (a) Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention) and (b) One-Month Follow-Up
Actual Adherence to Clinician Recommendations Scale
Measured: Change from Pre-Intervention to One-Month Follow-Up
Client Satisfaction Questionnaire
Measured: Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention)
Credibility and Expectancy Questionnaire
Measured: Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention)
Readiness to Change Scale
Measured: Change from Pre-Intervention to (a) Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention) and (b) One-Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start6 Sep 2017
- Primary completion2 Apr 2018
- Study completion2 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian Stanley, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272048
- Sponsor's protocol ID
- 2017.20703
- Other IDs
- 2017
- Status last verified
- Sep 2018
- First submitted
- 30 Aug 2017
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stanley IH, Hom MA, Sachs-Ericsson NJ, Gallyer AJ, Joiner TE. A pilot randomized clinical trial of a lethal means safety intervention for young adults with firearm familiarity at risk for suicide. J Consult Clin Psychol. 2020 Apr;88(4):372-383. doi: 10.1037/ccp0000481. Epub 2020 Jan 9.
PubMed 31916797
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Effective Approaches to Counseling on Firearm Safety: A Randomized Experimental Design Among Firearm-familiar Individuals at Risk for Suicide
- ClinicalTrials.gov ID
- NCT03272048
- Acronym / sponsor ID
- 2017.20703
- Conditions
- Suicide
- Keywords
- Firearms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 2 Apr 2018 (actual)
- First posted
- 5 Sep 2017 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-Fear/Not-Temporary | Experimental | Behavioral: Lethal Means Counseling |
| Low-Fear/Temporary | Experimental | Behavioral: Lethal Means Counseling |
| High-Fear/Not-Temporary | Experimental | Behavioral: Lethal Means Counseling |
| High-Fear/Temporary | Experimental | Behavioral: Lethal Means Counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Lifetime history of suicidal ideation or a suicide attempt
- Firearm familiarity (based on participants' self-report that they currently own a firearm, previously owned a firearm, have access to a firearm, have a desire to obtain a firearm in the future, or intend to obtain a firearm in the future)
Key exclusion criteria (2 listed)
- Younger than 18 years old
- Imminent risk of harm to self or others necessitating hospitalization
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 |
|---|---|---|
| Lethal Means CounselingLethal means counseling is broadly defined as clinician-initiated discussions that encourage an individual at risk for suicide to safely store his or her firearms. Examples in this domain include applying a gun lock, separating the gun from its ammunition, dismantling the firearm and keeping its components locked and/or separated, or safely transferring the firearm to a trusted loved one, friend, or police station until risk abates (Bryan, Stone, \& Rudd, 2011; Jin, Khazem, \& Anestis, 2016). Further, given that recent purchasers of firearms are at markedly increased risk of death by suicide (Wintemute, Parham, Beaumont, Wright, \& Drake, 1999), anticipatory counseling on firearm safety should also be considered for at-risk individuals who do not report currently owning or having access to a firearm, but who report prior firearm ownership/access or intentions of obtaining a firearm in the future (Harvard T.H. Chan School of Public Health, 2017). | Behavioural | High-Fear/Not-Temporary, High-Fear/Temporary, Low-Fear/Not-Temporary, Low-Fear/Temporary |
Primary outcome
Self-Reported Intentions to Adhere to Clinician Recommendations Scale
Time frame: Change from Pre-Intervention to (a) Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention) and (b) One-Month Follow-Up
Actual Adherence to Clinician Recommendations Scale
Time frame: Change from Pre-Intervention to One-Month Follow-Up
Client Satisfaction Questionnaire
Time frame: Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention)
Credibility and Expectancy Questionnaire
Time frame: Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention)
Readiness to Change Scale
Time frame: Change from Pre-Intervention to (a) Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention) and (b) One-Month Follow-Up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Derived from this study: PubMed 31916797Stanley IH, Hom MA, Sachs-Ericsson NJ, Gallyer AJ, Joiner TE. A pilot randomized clinical trial of a lethal means safety intervention for young adults with firearm familiarity at risk for suicide. J Consult Clin Psychol. 2020 Apr;88(4):372-383. doi: 10.1037/ccp0000481. Epub 2020 Jan 9.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lethal Means Counseling in people with Suicide, run by Florida State University 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 11 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Intentions to Adhere to Clinician Recommendations Scale (time frame: Change from Pre-Intervention to (a) Immediately Post-Intervention (i.e., assessed within minutes of completing the intervention) and (b) One-Month Follow-Up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03272048, which also lists 1 linked publication.
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 11 Sep 2018.