Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents

• ClinicalTrials.gov Identifier: NCT05423483
• Recruitment Status: Recruiting
• First Posted: June 21, 2022
• Last Update Posted: October 4, 2022
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): Beth Kennard, University of Texas Southwestern Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Suicide	Behavioral: Safe Home Text Message Reminders	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents: Randomization
• Actual Study Start Date: September 8, 2022
• Estimated Primary Completion Date: June 2024
• Estimated Study Completion Date: August 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Text Message Intervention; Parents in the intervention arm will receive text message reminders to restrict lethal means for 6 months.	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.
No Intervention: Treatment as Usual; Parents in the treatment as usual group will not receive the text message intervention.

Outcome Measures

Primary Outcome Measures :

1. Adolescent suicidal behavior [ Time Frame: 6 months ]
   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).
2. Parent satisfaction as measured by CSQ-8 [ Time Frame: 6 months ]
   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
3. Parent suicide prevention self efficacy as measured by parent suicide prevention self efficacy scale [ Time Frame: 6 months ]
   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)

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 100 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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+)

Exclusion Criteria:

• Non-English speaking

Contacts and Locations

Locations

United States, Texas

Children's Health; Recruiting

Dallas, Texas, United States, 75235

Contact: Beth Kennard, PsyD 214-500-6605 beth.kennard@utsouthwestern.edu

Contact: Ellen Andrews, BA 210-287-2035 ellen.andrews@utsouthwestern.edu

Sponsors and Collaborators

University of Texas Southwestern Medical Center

More Information

• Responsible Party: Beth Kennard, Professor of Psychiatry, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT05423483
• Other Study ID Numbers: STU-2022-0396
• First Posted: June 21, 2022
• Last Update Posted: October 4, 2022
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Suicide; Self-Injurious Behavior; Behavioral Symptoms