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

NCT07111052 | Enrolling By Invitation

• 1 other identifier: AAAV6627
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Suicide; Suicide Attempt; Adolescent Suicidality; Suicide Ideation

Keywords

adolescent suicide; lethal means counseling; lethal means access; adolescent suicide prevention

Outcome Measures

Primary Outcomes (1)

• Proportion of caregivers who improved home storage of medications and/or firearms

  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.

  Baseline (ED visit), 1 month follow-up

Secondary Outcomes (4)

• Mean Decision Conflict Scale Score (low literacy)

  Baseline (ED visit)

• Number of subsequent ED visits for suicide-related events

  From ED enrollment to 3-months after baseline ED visit

• Feasibility of Intervention Measure - Instrument Score

  Baseline (ED visit)

• Acceptability of Intervention: Instrument score

  Baseline (ED visit)

Study Arms (2)

Lock and Protect, web-based lethal means counseling intervention

EXPERIMENTAL

Guardians and patients will receive the intervention, Lock and Protect, is a user-friendly web-based decision aid that identifies preferences and explores options for removing or storing lethal means safety.

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

Usual care

NO INTERVENTION

All patients enrolled in the study, as part of usual care, will receive evaluation by the pediatric psychiatry team. This includes in-depth interviews about suicide risk and self-harm. All patients enrolled in this study are 1) evaluated by the pediatric psychiatry team and 2) evaluated for safety and suicide risk that informs if inpatient behavioral health admission is warranted based on the assessment. All patients who are eligible for study enrollment, as part of usual care for patients presenting for suicidal thoughts and behaviors or self-harm, will receive standard safety procedures while undergoing evaluation in the ED. These ED specific safety procedures include clinical observation of the patient while deemed to be at risk for any form of self-harm, removal of any phones and/or personal items that may be used for self-harm, being placed in behavioral health specific ED evaluation rooms, and (when warranted) security team presence.

Interventions

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

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.

Lock and Protect, web-based lethal means counseling intervention

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Morgan Stanley Children's Hospital, Pediatric Emergency

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Suicide; Suicide, Attempted

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Ashley Blanchard, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics in Emergency Medicine

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 8, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (1)