SuicideNCT07111052
Lock and Protect: Reducing Adolescent Access to Lethal Means of Suicide
A study testing Lock and Protect is a self-administered, web-based decision aid for caregivers of adolescents at risk for suicide. in people with Suicide and Suicide Attempt, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Suicide, Suicide Attempt, Adolescent Suicidality
- What is being tested?
- Lock and Protect is a self-administered, web-based decision aid for caregivers of adolescents at risk for suicide.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Morgan Stanley Children's Hospital, Pediatric Emergency
New York, New York, 10032
About this study
Official title: Lock and Protect: An Emergency Department Randomized Controlled Trial to Reduce Adolescent Access to Lethal Means of Suicide
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.
Read the 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.
- Conditions
- Suicide, Suicide Attempt, Adolescent Suicidality, Suicide Ideation
- Being tested
- Lock and Protect is a self-administered, web-based decision aid for caregivers of adolescents at risk for suicide.
- Keywords
- adolescent suicide, lethal means counseling, lethal means access, adolescent suicide prevention
- Medical subject headings
- Suicide, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lock and Protect is a self-administered, web-based decision aid for caregivers of adolescents at risk for suicide.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (ED visit), 1 month follow-up
Secondary outcomes (4)
Mean Decision Conflict Scale Score (low literacy)
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).
Measured: Baseline (ED visit)
Number of subsequent ED visits for suicide-related events
The study will assess subsequent adolescent ED visits for NSSI, suicidal ideation, or suicide attempt, within 3 months of baseline ED visit.
Measured: From ED enrollment to 3-months after baseline ED visit
Feasibility of Intervention Measure - Instrument Score
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.
Measured: Baseline (ED visit)
Acceptability of Intervention: Instrument score
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.
Measured: Baseline (ED visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start11 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley Blanchard, Columbia University
- Investigators
- Ashley Blanchard, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111052
- Sponsor's protocol ID
- AAAV6627
- Status last verified
- Dec 2025
- First submitted
- 6 Aug 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lock and Protect: An Emergency Department Randomized Controlled Trial to Reduce Adolescent Access to Lethal Means of Suicide
- ClinicalTrials.gov ID
- NCT07111052
- Acronym / sponsor ID
- AAAV6627
- Conditions
- Suicide, Suicide Attempt, Adolescent Suicidality, Suicide Ideation
- Keywords
- adolescent suicide, lethal means counseling, lethal means access, adolescent suicide prevention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lock and Protect, web-based lethal means counseling intervention | Experimental | Behavioral: Lock and Protect is a self-administered, web-based decision aid for caregivers of adolescents at risk for suicide.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. |
| 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 increasing adolescent safety during a time of elevated risk. | Behavioural | Lock and Protect, web-based lethal means counseling intervention |
Primary outcome
Proportion of caregivers who improved home storage of medications and/or firearms
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.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashley Blanchard, MD, MS principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lock and Protect is a self-administered, web-based decision aid for caregivers of adolescents at risk for suicide. in people with Suicide and Suicide Attempt, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of caregivers who improved home storage of medications and/or firearms (time frame: Baseline (ED visit), 1 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.