Lock and Protect for Teenage Suicide

Overseen By Ashley Blanchard, MD, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Autism, Intellectual disability, Active psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a web-based tool called Lock and Protect, designed to assist families in making decisions about safely storing firearms and medications in homes with teenagers at risk of self-harm. Researchers seek to determine if families find this tool easy to use and if it enhances caregivers' confidence in maintaining home safety. The trial will compare the usual care in an emergency department (ED) with this new tool to assess any additional benefits. Teenagers aged 13-17 who visit the ED for suicidal thoughts, behaviors, or self-injury, along with their caregivers, may be suitable candidates for this study. As an unphased trial, it offers families the chance to contribute to significant research that could improve home safety strategies.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Lock and Protect decision aid is safe for use in teenage suicide prevention?

Research has shown that "Lock and Protect" is the first online tool designed to assist parents of suicidal youth with safe storage advice. This user-friendly tool helps families find ways to safely store or remove potential dangers like guns and medications at home.

As a digital tool, "Lock and Protect" avoids physical side effects associated with medications. It aims to improve safety and reduce risks for teens. Studies suggest that this type of counseling effectively promotes safer environments. No reports of negative effects have emerged from using this tool, making it a safe option for families seeking guidance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lock and Protect intervention because it offers a fresh, web-based approach to addressing teenage suicide risk. Unlike standard treatments that often focus on in-person evaluations and psychiatric interventions, Lock and Protect empowers guardians and teens with a decision aid that helps identify and manage access to lethal means in a safe and effective way. This innovative method not only supports safety but also engages families directly in the prevention process, making it a potentially powerful addition to existing care strategies.

What evidence suggests that the Lock and Protect intervention is effective for teenage suicide prevention?

Research has shown that "Lock and Protect," an intervention in this trial, serves as a helpful tool for preventing suicide. This digital guide assists caregivers in safely storing dangerous items, thereby reducing suicide risk. Experts agree that keeping lethal items out of reach effectively prevents suicide. In one study, 94% of participants rated the information from "Lock and Protect" as good to excellent. This suggests "Lock and Protect" could be a valuable resource for parents and caregivers aiming to make their homes safer. ^{1 2 5 6 7}

Who Is on the Research Team?

Ashley Blanchard, MD, MS

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for caregivers of adolescents who are at risk for suicide. It aims to help them secure potentially dangerous items like firearms and medications in the home. There's no specific mention of inclusion or exclusion criteria provided, so it appears open to any caregiver in this situation.

Inclusion Criteria

I am the parent or caregiver of a teen (13-17) who has suicidal thoughts or self-harms.

I am a teenager who has self-harmed or had suicidal thoughts.

Both my caregiver and I agree to participate.

Exclusion Criteria

Patients with autism, intellectual disability, or active psychosis

Both my caregiver and I agree to participate in the study.

Caregivers who do not reside in the same home as the patient for at least 2 nights a week

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Intervention

Caregivers receive the Lock and Protect intervention during the ED visit

Baseline (ED visit)

1 visit (in-person)

Follow-up

Participants are monitored for changes in home access to medications and/or firearms

1 month

1 survey (self-administered)

Extended Follow-up

Assessment of subsequent ED visits for suicide-related events

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Lock and Protect

Trial Overview The 'Lock and Protect' program being tested is a web-based decision aid designed for caregivers. The study will assess how acceptable and feasible it is to implement this tool, as well as its immediate effects on safety practices at home.

How Is the Trial Designed?

Group I: Lock and Protect, web-based lethal means counseling intervention Experimental Treatment 1 Intervention

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.

Group II: Usual care Active Control 1 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.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8528190/

“Lock and Protect”: Development of a Digital Decision Aid ... Objective: Reducing access to lethal methods is an effective suicide prevention strategy that is often neglected in routine care.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07111052

Lock and Protect: Reducing Adolescent Access to Lethal ... Our expert team has developed a novel, low-resource, tablet-based intervention termed Lock and Protect intended to decrease risk of suicide in adolescents ...

3. trialx.com trialx.com/clinical-trials/listings/325353/lock-and-protect-reducing-adolescent-access-to-lethal-means-of-suicide/

Lock and Protect: Reducing Adolescent Access to Lethal ... Suicide rates increased 22% from 2005-2015, with a 28% increase in New York State. Emergency Departments (EDs) capture a medically underserved ...

4. researchgate.net researchgate.net/publication/354326156_Lock_and_Protect_Development_of_a_Digital_Decision_Aid_to_Support_Lethal_Means_Counseling_in_Parents_of_Suicidal_Youth

“Lock and Protect”: Development of a Digital Decision Aid ... Ninety-four percent of participants rated the information on reducing access to lethal means as good to excellent, and 91% rated the information ...

5. annemergmed.com annemergmed.com/article/S0196-0644(25)00116-7/pdf

Youth Suicide Prevention in the Emergency Department In this piece, we discuss the need for suicide prevention in the ED, the evidence behind lethal means counseling and effective strategies for implementation in ...

6. trial.medpath.com trial.medpath.com/clinical-trial/e09de9dd21dd205e/nct07111052-emergency-department-trial-reduce-adolescent-suicide

Reducing Adolescent Access to Lethal Means of Suicide Our expert team has developed a novel, low-resource, tablet-based intervention termed Lock and Protect intended to decrease risk of suicide in adolescents ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0891524524002591

Preventing Suicide Through Lethal Means Restriction in ... This article explores the data and practice evidence for lethal means restriction and counseling, focusing on clinical strategies and policy changes to reduce ...