NCT05423483

Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents

Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents: Randomization

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 12 Years – 100 Years
• Healthy volunteers: Accepted

Summary

Study Objective: to develop a phone-based intervention to aid parents of suicidal adolescents to adhere to lethal means safety. Lethal means counseling is the practice of educating patients and their families about limiting access to items that can be used to attempt suicide. Though lethal means counseling is standard practice in treating suicidal patients, there is little experimental literature related to its utilization across different providers and its efficacy. Further, there is a significant gap in the literature on lethal means counseling as it relates to adolescents. The proposed project will investigate a novel text message-based intervention aimed to promote lethal means safety.

Detailed description

Participants will be adolescents (age 12-17) who are currently enrolled in the SPARC IOP for a recent suicide attempt or significant suicidal ideation with a plan or intent and their parents or legal guardians. SPARC clinical staff will identify patients and parents who would be eligible based on inclusion/exclusion criteria provided to them. If the family is interested, the study staff will be on hand to present the study and collect informed assent from patients and consent from parent(s). Investigators will enroll up to 120 pairs of parents and teens receiving care at the SPARC clinic. Investigators will utilize a Children's Health HIPAA compliant texting services to send prompts to the parents of the teens. Phase I of the study was approved in STU-2020-0100 in which the team developed interviews and data collection guides. In Phase II, approved in STU-2021-0658, the team is conducting pilot testing of the intervention to determine if parents find it useful. In this study, Phase III, investigators will randomize the families into two groups: the first being the treatment as usual (TAU) group (N = 60) and the second being the intervention group (N = 60). Parents and guardians in the control group will not receive the text-based intervention. In the intervention group, parents of teens currently enrolled in the SPARC program will enroll in and receive text-based reminders (safety prompts and questionnaire) to adhere to lethal means safety practices twice a week, serving as an intervention to increase adherence to lethal means safety. Data will be collected at 4 time points: SPARC intake, SPARC discharge, 1 month following SPARC discharge, and 6 month following SPARC discharge. At 1-month and 6-month follow up, parents will complete Client Satisfaction Questionnaire regarding satisfaction with the intervention, a brief measure of family functioning, and a brief measure of parental-self efficacy in the context of their child's suicidality. Additionally, at 1-month and 6-month follow up, adolescents will complete questionnaires regarding their access to lethal means in the time frame and measures of suicidality and symptomatology. All 1-month and 6-month questionnaires will be completed by families digitally or over the phone.

Conditions

• Suicide

Interventions

Type	Name	Description
BEHAVIORAL	Safe Home Text Message Reminders	Text messages sent 2x a week with reminders to keep lethal means restricted and surveys of lethal means practices that serve as a prompt to adhere to suggested restriction measures.

Timeline

• Start date: 2022-09-08
• Primary completion: 2024-01-16
• Completion: 2024-07-19
• First posted: 2022-06-21
• Last updated: 2025-03-03

Locations

1 site across 1 country: United States