Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents
Primary Purpose
Suicide
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Safe Home Text Message Reminders
Sponsored by
About this trial
This is an interventional prevention trial for Suicide
Eligibility 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
Sites / Locations
- Children's HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Text Message Intervention
Treatment as Usual
Arm Description
Parents in the intervention arm will receive text message reminders to restrict lethal means for 6 months.
Parents in the treatment as usual group will not receive the text message intervention.
Outcomes
Primary Outcome Measures
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).
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
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05423483
First Posted
May 31, 2022
Last Updated
September 14, 2023
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05423483
Brief Title
Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents
Official Title
Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents: Randomization
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Text Message Intervention
Arm Type
Experimental
Arm Description
Parents in the intervention arm will receive text message reminders to restrict lethal means for 6 months.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Parents in the treatment as usual group will not receive the text message intervention.
Intervention Type
Behavioral
Intervention Name(s)
Safe Home Text Message Reminders
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adolescent suicidal behavior
Description
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).
Time Frame
6 months
Title
Parent satisfaction as measured by CSQ-8
Description
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
Time Frame
6 months
Title
Parent suicide prevention self efficacy as measured by parent suicide prevention self efficacy scale
Description
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)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Children's Health
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Kennard, PsyD
Phone
214-500-6605
Email
beth.kennard@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Ellen Andrews, BA
Phone
210-287-2035
Email
ellen.andrews@utsouthwestern.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents
We'll reach out to this number within 24 hrs