An ED-based RCT of Lethal Means Counseling for Parents of At-Risk Youth
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|ClinicalTrials.gov Identifier: NCT03143283|
Recruitment Status : Completed
First Posted : May 8, 2017
Last Update Posted : September 10, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Suicidal and Self-injurious Behavior||Behavioral: Safety Study Lethal Means Counseling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||575 participants|
|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)|
|Official Title:||An ED-based Randomized Clinical Trial of Lethal Means Counseling for Parents of Youth at Risk for Suicide|
|Actual Study Start Date :||August 1, 2017|
|Actual Primary Completion Date :||July 31, 2019|
|Actual Study Completion Date :||July 31, 2019|
No Intervention: Usual care
Hospital EDs are observed under usual care conditions (families receive usual care at the ED).
Experimental: Safety Study Lethal Means Counseling
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
Clinicians provide applicable families with locking devices and handouts on safe storage of firearms and medications.
- 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).
- Relevant decisional attitudinal and contextual factors [ Time Frame: Within six months of the ED visit ]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.
- Long-term parental change in lethal means storage practices [ Time Frame: 3 months after the ED visit ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143283
|United States, Colorado|
|Colorado Springs, Colorado, United States, 80907|
|Colorado Springs, Colorado, United States, 80909|
|Colorado Springs, Colorado, United States, 80920|
|St. Francis Hospital|
|Colorado Springs, Colorado, United States, 80923|
|Poudre Valley Hospital|
|Fort Collins, Colorado, United States, 80524|
|Medical Center of Rockies|
|Loveland, Colorado, United States, 80538|
|St. Mary Corwin Medical Center|
|Pueblo, Colorado, United States, 81004|
|Lutheran Medical Center|
|Wheat Ridge, Colorado, United States, 80033|
|Principal Investigator:||Matthew Miller, ScD||Northeastern University|