Suicidal and Self-injurious BehaviorNCT03143283
An ED-based RCT of Lethal Means Counseling for Parents of At-Risk Youth
A study testing Safety Study Lethal Means Counseling in people with Suicidal and Self-injurious Behavior, run by Northeastern University at 8 sites in United States.
Trial summary
The National Action Alliance to Prevent Suicide recently released a research agenda aimed at significantly reducing suicide over the next decade. Aspirational Goal 12, "Reduce access to lethal means that people use to attempt suicide," calls for identifying effective strategies to reduce a suicidal person's access to… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Suicidal and Self-injurious Behavior
- What is being tested?
- Safety Study Lethal Means Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 575 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Aug 2017to 31 Jul 2019
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age limits pertain to the patient seen at the ED for a psychiatric or substance abuse crisis. It is their parents/guardians who receive the intervention. Parents must speak either English or Spanish and have a working telephone number or email address.
Who cannot join
- A patient in institutional care would be excluded. Parents/guardians who were not at the ED with their child are excluded.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Penrose Hospital
Colorado Springs, Colorado, 80907
Memorial Central
Colorado Springs, Colorado, 80909
Memorial North
Colorado Springs, Colorado, 80920
St. Francis Hospital
Colorado Springs, Colorado, 80923
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Medical Center of Rockies
Loveland, Colorado, 80538
St. Mary Corwin Medical Center
Pueblo, Colorado, 81004
Lutheran Medical Center
Wheat Ridge, Colorado, 80033
About this study
Official title: An ED-based Randomized Clinical Trial of Lethal Means Counseling for Parents of Youth at Risk for Suicide
The National Action Alliance to Prevent Suicide recently released a research agenda aimed at significantly reducing suicide over the next decade. Aspirational Goal 12, "Reduce access to lethal means that people use to attempt suicide," calls for identifying effective strategies to reduce a suicidal person's access to firearms and other lethal means.
A promising strategy is to counsel patients seen in the emergency department (ED) for a psychiatric emergency to reduce access to firearms (the most lethal suicide method) and medications (the most common method of suicide attempt). To date, however, few studies have evaluated changes in firearm storage practices among those who received lethal means counseling (LMC), and those that have, including a pilot conducted in Colorado by the study team, have lacked control groups. Results from the pilot, which provided emergency department based LMC counseling to parents of suicidal adolescents, found that among gun-owning parents, 33% had unlocked guns at home on the day of the ED visit and none did on follow up.
Read more
Using the piloted LMC protocol, we will conduct the first randomized, controlled trial (RCT) of the effectiveness of ED-based LMC on firearm and medication storage. The proposed RCT, to be conducted in five Colorado hospitals, will test whether parents of at-risk adolescents who are treated in hospitals that have (vs. have not yet) implemented our LMC protocol are more likely to store household firearms and medications safely. In addition, we will conduct in-depth, qualitative interviews with parents who have received LMC counseling to better understand those factors that affect parents' willingness and ability to make changes to firearm and medication storage. We will also conduct qualitative interviews with clinicians to understand factors affecting clinician engagement in LMC.
AIM 1: To assess the effectiveness of an ED-based LMC intervention to improve how parents of pediatric patients (age 10-17) who visit the ED for a mental health emergency store household firearms and medication.
AIM 2: To examine how attitudinal and contextual factors shape a) parents' decisions about firearm and medication storage following LMC, and b) clinicians' delivery of LMC messages.
Read the detailed description
Suicide is the second leading cause of death for U.S. youth 10-17 years of age. Nationally, 51% of all suicides, and 40% of 10-17 year-olds' suicides, are completed with a firearm. In Colorado, which has the 6th highest adolescent suicide rate in the nation, more youth more youth die by suicide than in motor vehicle crashes. Every U.S. study that has addressed the relationship between access to firearms and suicide has found that such access increases risk of suicide, not only for the gun owner, but for all household members. Indeed, the relative risk of suicide associated with household firearms is highest for children and young adults, and elevated further in those households in which guns are stored loaded and unlocked.
Some of the largest reductions in national suicide rates have occurred when access to a commonly used and highly lethal suicide method was reduced. Consequently, reducing a suicidal person's access to lethal means of suicide ("means restriction") is a vital component of any effective national strategy for reducing suicide rates. Reducing access to firearms is particularly important given their greater lethality compared with other methods commonly used in US suicides and the very short deliberation period preceding nearly half of suicide attempts. Nonetheless, means restriction interventions remain uncommon. The CDC's recently released Research Priorities for the National Center for Injury Prevention and Control, acknowledges this gap and calls for evaluation of the feasibility, scalability, and economic efficiency of means restriction strategies.
A recent study estimated that over 40% of youth suicide victims were seen in the ED in the year preceding their death. EDs have been identified by the National Action Alliance for Suicide Prevention as one of two key arenas for improved services to reduce the proportion of at-risk youth who progress to suicide, yet LMC in emergency departments remains uncommon: ED clinicians often do not offer any lethal means counseling to at-risk patients and their families, and many do not counsel on reducing access to firearms in particular. For example, Grossman and colleagues reported that although 80% of emergency nurses in Illinois had recent experience with suicidal adolescents, only 28% provided LMC to parents. A record review found that psychiatric residents at a psychiatric emergency department assessed firearm access in only 3% of pediatric patients.
ED-based lethal means counseling with parents of youth is a promising approach, but no RCTs have been conducted: Previous studies on LMC point to the need for fully powered RCTs in this area. A prospective follow-up study at a hospital ED where staff were instructed to deliver LMC messages to parents of all at-risk youth found that parents exposed to LMC were more likely to reduce the youth's access to lethal means than parents who were not exposed (75% vs. 48% for prescription drugs and 63% vs. 0% for firearms), but the number of gun- owning households (n=15) was very small. Promising evidence also comes from the pilot investigation that members of the study team conducted at Children's Hospital Colorado.
Our research team, which includes experts in suicide prevention, LMC, evaluation science, qualitative research, adolescent mental health, and emergency medicine, is well-suited to rigorously evaluate the study aims using a mixed-methods approach. Our five hospital sites will collaborate with study personnel to: a) establish IRB procedures and approvals, b) develop a system (in nearly all sites via the electronic medical record) to flag eligible patients, document provision of intervention services, and provide parent contact information to the study team, c) require the clinicians who will provide LMC to take the online training during their sites' two-week phase-in period, d) host an in-person training with a study investigator at a staff meeting during the phase-in period, and e) implement the new lethal means counseling protocol on their start date. A lead ED clinician at each site will be the point of contact to help manage logistics and access medical record information for the study in accordance with HIPAA regulations. The Colorado-based project coordinator (Brandspigel) will work with hospitals to develop site-specific consent and data transfer processes.
- Conditions
- Suicidal and Self-injurious Behavior
- Being tested
- Safety Study Lethal Means Counseling
- Keywords
- suicide, lethal means, counseling, youth, parents, firearms, medication, suicidal, emergency department
- Medical subject headings
- Self-Injurious Behavior, Suicide, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Study Lethal Means CounselingBehavioural
Clinicians provide applicable families with locking devices and handouts on safe storage of firearms and medications.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Hospital EDs are observed under usual care conditions (families receive usual care at the ED). |
| Safety Study Lethal Means Counseling | Experimental | During the intervention phase, mental health clinicians at EDs of participating hospitals are trained in lethal means counseling and implement the new protocol uniformly with eligible families. Receives: Behavioral: Safety Study Lethal Means Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term parental change in lethal means storage practices
Self-reported firearm and medication storage practices following the ED visit, as compared with on the day of the visit. Specifically, we will assess the following among gun-owning parents: 1) removal of firearms from the home; 2) change in firearm storage practices from keeping a firearm unlocked to storing it locked; and 3) change in practice from keeping a firearm loaded to unloaded. In addition, we will assess parental storage of medications (from unlocked to locked).
Measured: 1-3 weeks after the ED visit
Secondary outcomes (2)
Relevant decisional attitudinal and contextual factors
Qualitative, face-to-face or video semi-structured in-depth interviews with clinicians and parents/caregivers of adolescents eligible for our RCT using a grounded theory approach. The focus of the interviews will be on understanding how the intervention effects behavior change with an emphasis on reducing at-risk adolescents' access to firearms.
Measured: Within six months of the ED visit
Long-term parental change in lethal means storage practices
Self-reported firearm and medication storage practices several months after the ED visit, as compared with on the day of the visit. Specifically, we will assess the following among gun-owning parents: 1) removal of firearms from the home; 2) change in firearm storage practices from keeping a firearm unlocked to storing it locked; and 3) change in practice from keeping a firearm loaded to unloaded. In addition, we will assess parental storage of medications (from unlocked to locked).
Measured: 3 months after the ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start1 Aug 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
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 Suicidal and Self-injurious BehaviorStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- We will use a stepped wedge sample design, a type of cluster randomized crossover design in which different clusters (in our case, hospitals) switch permanently from a control to an intervention state at different time points (steps) (Woertman, 2013). We chose a cluster-randomized design to prevent contamination that would likely occur were providers or patients randomized to receive different interventions within hospitals. All clusters start in the control condition (usual care), with hospitals switching to the intervention at consecutive 3- month time points, where the time of the switch is randomized for every hospital. At the end of the study period, all clusters will have switched from a control to an intervention condition.
- Masking
- None (open label)
- Enrolment
- 575 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado School of Public Health, Harvard School of Public Health (HSPH), American Foundation for Suicide Prevention
- Responsible party
- Principal investigator, Matthew Miller, Northeastern University
- Investigators
- Matthew Miller, ScD, Principal investigator, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143283
- Sponsor's protocol ID
- TBT-0-013-15
- Status last verified
- Sep 2020
- First submitted
- 3 May 2017
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miller M, Salhi C, Barber C, Azrael D, Beatriz E, Berrigan J, Brandspigel S, Betz ME, Runyan C. Changes in Firearm and Medication Storage Practices in Homes of Youths at Risk for Suicide: Results of the SAFETY Study, a Clustered, Emergency Department-Based, Multisite, Stepped-Wedge Trial. Ann Emerg Med. 2020 Aug;76(2):194-205. doi: 10.1016/j.annemergmed.2020.02.007. Epub 2020 Apr 16.
PubMed 32307124
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An ED-based Randomized Clinical Trial of Lethal Means Counseling for Parents of Youth at Risk for Suicide
- ClinicalTrials.gov ID
- NCT03143283
- Acronym / sponsor ID
- TBT-0-013-15
- Conditions
- Suicidal and Self-injurious Behavior
- Keywords
- suicide, lethal means, counseling, youth, parents, firearms, medication, suicidal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Collaborators
- Colorado School of Public Health, Harvard School of Public Health (HSPH), American Foundation for Suicide Prevention
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 8 May 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.
The National Action Alliance to Prevent Suicide recently released a research agenda aimed at significantly reducing suicide over the next decade. Aspirational Goal 12, "Reduce access to lethal means that people use to attempt suicide," calls for identifying effective strategies to reduce a suicidal person's access to firearms and other lethal means.
A promising strategy is to counsel patients seen in the emergency department (ED) for a psychiatric emergency to reduce access to firearms (the most lethal suicide method) and medications (the most common method of suicide attempt). To date, however, few studies have evaluated changes in firearm storage practices among those who received lethal means counseling (LMC), and those that have, including a pilot conducted in Colorado by the study team, have lacked control groups. Results from the pilot, which provided emergency department based LMC counseling to parents of suicidal adolescents, found that among gun-owning parents, 33% had unlocked guns at home on the day of the ED visit and none did on follow up.
Using the piloted LMC protocol, we will conduct the first randomized, controlled trial (RCT) of the effectiveness of ED-based LMC on firearm and medication storage. The proposed RCT, to be conducted in five Colorado hospitals, will test whether parents of at-risk adolescents who are treated in hospitals that have (vs. have not yet) implemented our LMC protocol are more likely to store household firearms and medications safely. In addition, we will conduct in-depth, qualitative interviews with parents who have received LMC counseling to better understand those factors that affect parents' willingness and ability to make changes to firearm and medication storage. We will also conduct qualitative interviews with clinicians to understand factors affecting clinician engagement in LMC.
AIM 1: To assess the effectiveness of an ED-based LMC intervention to improve how parents of pediatric patients (age 10-17) who visit the ED for a mental health emergency store household firearms and medication.
AIM 2: To examine how attitudinal and contextual factors shape a) parents' decisions about firearm and medication storage following LMC, and b) clinicians' delivery of LMC messages.
Detailed description
Suicide is the second leading cause of death for U.S. youth 10-17 years of age. Nationally, 51% of all suicides, and 40% of 10-17 year-olds' suicides, are completed with a firearm. In Colorado, which has the 6th highest adolescent suicide rate in the nation, more youth more youth die by suicide than in motor vehicle crashes. Every U.S. study that has addressed the relationship between access to firearms and suicide has found that such access increases risk of suicide, not only for the gun owner, but for all household members. Indeed, the relative risk of suicide associated with household firearms is highest for children and young adults, and elevated further in those households in which guns are stored loaded and unlocked.
Some of the largest reductions in national suicide rates have occurred when access to a commonly used and highly lethal suicide method was reduced. Consequently, reducing a suicidal person's access to lethal means of suicide ("means restriction") is a vital component of any effective national strategy for reducing suicide rates. Reducing access to firearms is particularly important given their greater lethality compared with other methods commonly used in US suicides and the very short deliberation period preceding nearly half of suicide attempts. Nonetheless, means restriction interventions remain uncommon. The CDC's recently released Research Priorities for the National Center for Injury Prevention and Control, acknowledges this gap and calls for evaluation of the feasibility, scalability, and economic efficiency of means restriction strategies.
A recent study estimated that over 40% of youth suicide victims were seen in the ED in the year preceding their death. EDs have been identified by the National Action Alliance for Suicide Prevention as one of two key arenas for improved services to reduce the proportion of at-risk youth who progress to suicide, yet LMC in emergency departments remains uncommon: ED clinicians often do not offer any lethal means counseling to at-risk patients and their families, and many do not counsel on reducing access to firearms in particular. For example, Grossman and colleagues reported that although 80% of emergency nurses in Illinois had recent experience with suicidal adolescents, only 28% provided LMC to parents. A record review found that psychiatric residents at a psychiatric emergency department assessed firearm access in only 3% of pediatric patients.
ED-based lethal means counseling with parents of youth is a promising approach, but no RCTs have been conducted: Previous studies on LMC point to the need for fully powered RCTs in this area. A prospective follow-up study at a hospital ED where staff were instructed to deliver LMC messages to parents of all at-risk youth found that parents exposed to LMC were more likely to reduce the youth's access to lethal means than parents who were not exposed (75% vs. 48% for prescription drugs and 63% vs. 0% for firearms), but the number of gun- owning households (n=15) was very small. Promising evidence also comes from the pilot investigation that members of the study team conducted at Children's Hospital Colorado.
Our research team, which includes experts in suicide prevention, LMC, evaluation science, qualitative research, adolescent mental health, and emergency medicine, is well-suited to rigorously evaluate the study aims using a mixed-methods approach. Our five hospital sites will collaborate with study personnel to: a) establish IRB procedures and approvals, b) develop a system (in nearly all sites via the electronic medical record) to flag eligible patients, document provision of intervention services, and provide parent contact information to the study team, c) require the clinicians who will provide LMC to take the online training during their sites' two-week phase-in period, d) host an in-person training with a study investigator at a staff meeting during the phase-in period, and e) implement the new lethal means counseling protocol on their start date. A lead ED clinician at each site will be the point of contact to help manage logistics and access medical record information for the study in accordance with HIPAA regulations. The Colorado-based project coordinator (Brandspigel) will work with hospitals to develop site-specific consent and data transfer processes.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will use a stepped wedge sample design, a type of cluster randomized crossover design in which different clusters (in our case, hospitals) switch permanently from a control to an intervention state at different time points (steps) (Woertman, 2013). We chose a cluster-randomized design to prevent contamination that would likely occur were providers or patients randomized to receive different interventions within hospitals. All clusters start in the control condition (usual care), with hospitals switching to the intervention at consecutive 3- month time points, where the time of the switch is randomized for every hospital. At the end of the study period, all clusters will have switched from a control to an intervention condition.
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Hospital EDs are observed under usual care conditions (families receive usual care at the ED). |
| Safety Study Lethal Means Counseling | Experimental | Behavioral: Safety Study Lethal Means CounselingDuring the intervention phase, mental health clinicians at EDs of participating hospitals are trained in lethal means counseling and implement the new protocol uniformly with eligible families. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age limits pertain to the patient seen at the ED for a psychiatric or substance abuse crisis. It is their parents/guardians who receive the intervention. Parents must speak either English or Spanish and have a working telephone number or email address.
Key exclusion criteria (1 listed)
- A patient in institutional care would be excluded. Parents/guardians who were not at the ED with their child are excluded.
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 |
|---|---|---|
| Safety Study Lethal Means CounselingClinicians provide applicable families with locking devices and handouts on safe storage of firearms and medications. | Behavioural | Safety Study Lethal Means Counseling |
Primary outcome
Short-term parental change in lethal means storage practices
Time frame: 1-3 weeks after the ED visit
Self-reported firearm and medication storage practices following the ED visit, as compared with on the day of the visit. Specifically, we will assess the following among gun-owning parents: 1) removal of firearms from the home; 2) change in firearm storage practices from keeping a firearm unlocked to storing it locked; and 3) change in practice from keeping a firearm loaded to unloaded. In addition, we will assess parental storage of medications (from unlocked to locked).
2 secondary outcomes
Relevant decisional attitudinal and contextual factors
Time frame: Within six months of the ED visit
Long-term parental change in lethal means storage practices
Time frame: 3 months after the ED visit
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 10 Sep 2020.
- Derived from this study: PubMed 32307124Miller M, Salhi C, Barber C, Azrael D, Beatriz E, Berrigan J, Brandspigel S, Betz ME, Runyan C. Changes in Firearm and Medication Storage Practices in Homes of Youths at Risk for Suicide: Results of the SAFETY Study, a Clustered, Emergency Department-Based, Multisite, Stepped-Wedge Trial. Ann Emerg Med. 2020 Aug;76(2):194-205. doi: 10.1016/j.annemergmed.2020.02.007. Epub 2020 Apr 16.
- Individual participant dataSharing planned: No
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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.
Matthew Miller, ScD principal investigator
Northeastern University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Study Lethal Means Counseling in people with Suicidal and Self-injurious Behavior, run by Northeastern University at 8 sites 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 1 inclusion and 1 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 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Short-term parental change in lethal means storage practices (time frame: 1-3 weeks after the ED visit). 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 NCT03143283, 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 10 Sep 2020; AzTrials last refreshed its copy on 6 Nov 2026.