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Enrolling by invitation NCT07111052

Lock and Protect: Reducing Adolescent Access to Lethal Means of Suicide

No phase Interventional Suicide Suicide Attempt Adolescent Suicidality Suicide Ideation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lock and Protect is a self-administered, web-based decision aid for caregivers of adolescents at risk for suicide..
Who it may be relevant to
Registry conditions: Suicide, Suicide Attempt, Adolescent Suicidality, Suicide Ideation. Basic parameters: 13 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Lock and Protect: An Emergency Department Randomized Controlled Trial to Reduce Adolescent Access to Lethal Means of Suicide

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Lock and Protect is a self-administered, web-based decision aid for caregivers of adolescents at risk for suicide.
    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 inc

Primary outcome measures

  • Proportion of caregivers who improved home storage of medications and/or firearms [Time frame: Baseline (ED visit), 1 month follow-up]
Secondary outcome measures (4)
  • Mean Decision Conflict Scale Score (low literacy) [Time frame: Baseline (ED visit)]
  • Number of subsequent ED visits for suicide-related events [Time frame: From ED enrollment to 3-months after baseline ED visit]
  • Feasibility of Intervention Measure - Instrument Score [Time frame: Baseline (ED visit)]
  • Acceptability of Intervention: Instrument score [Time frame: Baseline (ED visit)]

Eligibility criteria

Inclusion Criteria: (Both caregiver and patient must agree to participation to be eligible)

  • Parents or caregivers of adolescents aged 13-17 years presenting to the ED for suicidal thoughts and/or behaviors or non-suicidal self-injury as defined by presenting complaint or initial provider assessment.
  • Patients ages 13-17 years-old presenting to the ED for non-suicidal self-injury (NSSI), suicidal thoughts and behaviors

Exclusion criteria

  • Medically unstable children
  • Patients with autism, intellectual disability, or active psychosis
  • Lack of parental and/or youth English and/or Spanish fluency
  • Caregivers who do not reside in the same home as the patient for at least 2 nights a week
  • If the caregiver OR patient does not agree to participation both participants will be excluded

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Morgan Stanley Children's Hospital, Pediatric Emergency — New York

Identifiers

NCT: NCT07111052 · AAAV6627

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗