Lock and Protect: Reducing Adolescent Access to Lethal Means of Suicide
- Conditions
- SuicideSuicide AttemptAdolescent SuicidalitySuicide Ideation
- Registration Number
- NCT07111052
- Lead Sponsor
- Columbia University
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
(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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of caregivers who improved home storage of medications and/or firearms 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.
- Secondary Outcome Measures
Name Time Method Mean Decision Conflict Scale Score (low literacy) 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).
Number of subsequent ED visits for suicide-related events 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.
Feasibility of Intervention Measure - Instrument Score 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.Acceptability of Intervention: Instrument score 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.
Trial Locations
- Locations (1)
Morgan Stanley Children's Hospital, Pediatric Emergency
🇺🇸New York, New York, United States
Morgan Stanley Children's Hospital, Pediatric Emergency🇺🇸New York, New York, United StatesAshley Blanchard, MD, MSPrincipal InvestigatorAshley BlanchardContact