Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents

NCT05423483 | Completed Phase 2

• 1 other identifier: STU-2022-0396
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Suicide

Outcome Measures

Primary Outcomes (3)

• Adolescent suicidal behavior

  Adolescent suicidal behavior will be measured by Columbia Suicide Severity Rating Scale (C-SSRS) which is used to measure suicidal thoughts and behaviors in Investigational New Drug (IND) studies. The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).

  6 months

• Parent satisfaction as measured by CSQ-8

  Parent satisfaction will be measured by Client Satisfaction Questionnaire (CSQ-8) which is a self report measure of satisfaction with health and behavioral services received. The CSQ-8 is measured on a four point Likert scale from 1 "Quite Dissatisfied" to 4 "Very Satisfied." Scores range from 8-32, with higher values indicating higher satisfaction

  6 months

• Parent suicide prevention self efficacy as measured by parent suicide prevention self efficacy scale

  Parent suicide prevention self efficacy is measured by parent suicide prevention self efficacy scale which measures parent's confidence on a scale of 0 (not at all confident) to 10 (completely confident)

  6 months

Study Arms (2)

Text Message Intervention

EXPERIMENTAL

Parents in the intervention arm will receive text message reminders to restrict lethal means for 6 months.

Behavioral: Safe Home Text Message Reminders

Treatment as Usual

NO INTERVENTION

Parents in the treatment as usual group will not receive the text message intervention.

Interventions

Safe Home Text Message Reminders BEHAVIORAL

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.

Text Message Intervention

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Proficiency in spoken and written English
• Own cell phone that has internet capabilities
• Adolescent participants are patient's at Children's Health SPARC IOP (ages 12-17)
• Adult participants are parents and/or legal guardians of adolescent participants (ages 18+)

You may not qualify if:

• Non-English speaking

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Children's Health

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 21, 2022
• Study Start: September 8, 2022
• Primary Completion: January 16, 2024
• Study Completion: July 19, 2024
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)