Morgan Stanley Children's Hospital, Pediatric Emergency
New York, 10032, United States
NCT Number: NCT07111052
The primary goal is to determine the acceptability and feasibility of implementing the Lock and Protect decision aid. The secondary goals are to identify the potential short-term impact of Lock and Protect on home firearm and medication storage, parental self-efficacy. Using interviews with caregivers, the study will clarify the acceptability, feasibility, and barriers to implementing the Lock and Protect hone safety plan. This will allow further development of effective strategies to subsequently further test and use Lock and Protect in the ED.
NOTE: The study will only recruit guardians and their adolescents from the pediatric ED at Morgan Stanley Children's Hospital NY-Presbyterian.
Interested in participating?
Request Info13 year–17 year
All sexes
Interventional
Not applicable
New York, 10032, United States
Suicide is the second leading cause of death in adolescents in the United States. Suicide rates increased 22% from 2005-2015, with a 28% increase in New York State. Emergency Departments (EDs) capture a medically underserved population at high risk for suicide and provide an important but typically missed opportunity for adolescent suicide prevention. Reducing access to guns, medications, and other methods of suicide (also called lethal means restriction or counseling) is one of the few suicide prevention interventions found to decrease suicides. It is based on the idea that reducing access to highly lethal means of suicide during a time of vulnerability can prevent suicide by decreasing the lethality of attempts. This is of critical importance in adolescence, when the transition from thinking about suicide to committing or attempting suicide is often sudden and unplanned, using the most readily available method to attempt suicide. However, effective tools to facilitate suicide prevention, particularly restricting lethal mean access, are lacking. Our expert team has developed a novel, low-resource, tablet-based intervention termed Lock and Protect intended to decrease risk of suicide in adolescents evaluated in EDs.
The investigator will conduct a research study of parents or caregivers (hereafter referred to as caregivers) who receive the intervention during evaluation of their adolescent in the ED for suicidal ideation, self-ham, or suicide. The study will randomly assign caregivers; those who are assigned to the intervention will receive usual ED care and receive the Lock and Protect intervention. Guardians randomly assigned to receive usual ED care alone will complete study surveys in addition to usual ED care. Usual ED care for patients presenting with self-harm or suicidal thoughts and behaviors includes evaluation by the child psychiatry team and determination of risk to determine if safety planning (Stanley Brown safety plan completed in the medical chart), discharge home, or inpatient psychiatric admission is warranted. The study will enroll parents of youths 13-17 years-old presenting to the ED for suicidal thoughts or behaviors. Caregivers will not be part of the study if their child is medically unstable, a caregiver does not speak English or Spanish, and/or they do not reside in the same home as the patient. The investigator hopes to determine if home access to high-risk medications and/or firearms has changed at 1-month after ED visit. The study will also measure decision quality and behavioral intent through surveys.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(Both caregiver and patient must agree to participation to be eligible)
Exclusion criteria
Lock and Protect is a user-friendly web-based decision aid that identifies preferences and explores options for removing or storing lethal means safety through: (a) education on home means of suicide, such as firearms, medications, and other potentially dangerous home and external items/situations (e.g., poisons, methods/ligatures used in suffocation/hanging), and community hazards (e.g., subways, heights); (b) safe storage options; and (c) protective monitoring and supervision as a means of increasing adolescent safety during a time of elevated risk.
Time frame: Baseline (ED visit), 1 month follow-up
The primary efficacy outcome is change in home access to medications and/or firearms by 1-month post-discharge from the ED, as measured by a REDCap self-administered survey.
Time frame: Baseline (ED visit)
This outcome is designed to measure decision quality. Decision quality is a fundamental element of the Ottawa Decision Support Framework, as a marker of readiness to change. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Time frame: From ED enrollment to 3-months after baseline ED visit
The study will assess subsequent adolescent ED visits for NSSI, suicidal ideation, or suicide attempt, within 3 months of baseline ED visit.
Time frame: Baseline (ED visit)
This is to measure feasibility of intervention. A 4-item instrument measuring the feasibility of an intervention. Reported by caregivers, assigned to the intervention arm, after completion of the Lock and Protect intervention.
Score response range 1-5. Completely disagree (1) Disagree (2) Neither agree nor disagree (3) Agree (4) Completely agree (5)
Scale is created by averaging the 4 responses.
Time frame: Baseline (ED visit)
This is to measure acceptability of intervention. A 4-item instrument measuring the acceptability of an intervention. Completed by caregivers assigned to the intervention, after completing the Lock and Protect intervention.
Score response range 1-5. Completely disagree (1) Disagree (2) Neither agree nor disagree (3) Agree (4) Completely agree (5)
Scale is created by averaging the 4 responses.
Columbia University
Other
Lock and Protect: An Emergency Department Randomized Controlled Trial to Reduce Adolescent Access to Lethal Means of Suicide
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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