An ED-based RCT of Lethal Means Counseling for Parents of At-Risk Youth
Condition: Suicidal and Self-injurious Behavior
MeSH terms: Self-Injurious Behavior
Study type: Interventional

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 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.
    

Intervention name(s): Safety Study Lethal Means Counseling
Intervention type(s): Behavioral
Intervention description(s): Clinicians provide applicable families with locking devices and handouts on safe storage of firearms and medications.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention 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)
Primary purpose: Prevention
Keywords: suicide; lethal means; counseling; youth; parents; firearms; medication; suicidal; emergency department