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Trial record 9 of 125 for:    Recruiting, Not yet recruiting, Available Studies | "Self-Injurious Behavior"

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

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ClinicalTrials.gov Identifier: NCT03143283
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : August 22, 2018
Sponsor:
Collaborators:
Colorado School of Public Health
Harvard School of Public Health
American Foundation for Suicide Prevention
Information provided by (Responsible Party):
Matthew Miller, Northeastern University

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.


Condition or disease Intervention/treatment Phase
Suicidal and Self-injurious Behavior Behavioral: Safety Study Lethal Means Counseling Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: 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
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
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-Harm Suicide

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Contacts
Contact: Sara Brandspigel, MPH 303-724-6998 sara.brandspigel@ucdenver.edu
Contact: Carol Runyan, PhD 303-724-6499 carol.runyan@ucdenver.edu

Locations
United States, Colorado
Penrose Hospital Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Charlene Coffin, LPC    719-776-6553      
Memorial Central Recruiting
Colorado Springs, Colorado, United States, 80909
Contact: Billie Ratliff    719-365-6139      
Memorial North Recruiting
Colorado Springs, Colorado, United States, 80920
Contact: Billie Ratliff    719-365-6139      
St. Francis Hospital Recruiting
Colorado Springs, Colorado, United States, 80923
Contact: Charlene Coffin, LPC    719-776-6553      
Poudre Valley Hospital Recruiting
Fort Collins, Colorado, United States, 80524
Contact: Lyssa Stroup    970-624-1602      
Medical Center of Rockies Recruiting
Loveland, Colorado, United States, 80538
Contact: Lyssa Stroup         
Contact    970.624.1602      
St. Mary Corwin Medical Center Recruiting
Pueblo, Colorado, United States, 81004
Contact: Theresa Nicholas    719-557-5703    theresanicholas@centura.org   
Lutheran Medical Center Recruiting
Wheat Ridge, Colorado, United States, 80033
Contact: Cheryl Storey, LCSW    303-467-4013      
Sponsors and Collaborators
Northeastern University
Colorado School of Public Health
Harvard School of Public Health
American Foundation for Suicide Prevention
Investigators
Principal Investigator: Matthew Miller, ScD Northeastern University

Responsible Party: Matthew Miller, Professor of Health Sciences and Epidemiology, Northeastern University
ClinicalTrials.gov Identifier: NCT03143283     History of Changes
Other Study ID Numbers: TBT-0-013-15
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matthew Miller, Northeastern University:
suicide
lethal means
counseling
youth
parents
firearms
medication
suicidal
emergency department

Additional relevant MeSH terms:
Self-Injurious Behavior
Behavioral Symptoms