An ED-based RCT of Lethal Means Counseling for Parents of At-Risk Youth

NCT03143283 | Completed DMC

• 1 other identifier: TBT-0-013-15
• Study Type: interventional
• Target: 575
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Suicidal and Self-injurious Behavior

Keywords

suicide; lethal means; counseling; youth; parents; firearms; medication; suicidal; emergency department

Outcome Measures

Primary Outcomes (1)

• 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).

  1-3 weeks after the ED visit

Secondary Outcomes (2)

• Relevant decisional attitudinal and contextual factors

  Within six months of the ED visit

• Long-term parental change in lethal means storage practices

  3 months after the ED visit

Study Arms (2)

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.

Behavioral: Safety Study Lethal Means Counseling

Interventions

Safety Study Lethal Means Counseling BEHAVIORAL

Clinicians provide applicable families with locking devices and handouts on safe storage of firearms and medications.

Safety Study Lethal Means Counseling

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• A patient in institutional care would be excluded. Parents/guardians who were not at the ED with their child are excluded.

Sponsors & Collaborators

• Northeastern University: lead
• Colorado School of Public Health: collaborator
• Harvard School of Public Health (HSPH): collaborator
• American Foundation for Suicide Prevention: collaborator

Study Sites (8)

Penrose Hospital

Colorado Springs, Colorado, 80907, United States

Location

Memorial Central

Colorado Springs, Colorado, 80909, United States

Location

Memorial North

Colorado Springs, Colorado, 80920, United States

Location

St. Francis Hospital

Colorado Springs, Colorado, 80923, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Medical Center of Rockies

Loveland, Colorado, 80538, United States

Location

St. Mary Corwin Medical Center

Pueblo, Colorado, 81004, United States

Location

Lutheran Medical Center

Wheat Ridge, Colorado, 80033, United States

Location

Related Publications (1)

• 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.

  PMID: 32307124 DERIVED

MeSH Terms

Conditions

Self-Injurious Behavior; Suicide; Emergencies

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Miller, ScD

  Northeastern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health Sciences and Epidemiology

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 8, 2017
• Study Start: August 1, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)