Preventing Suicide Among Sexual and Gender Diverse Young Adults in Primary Care in Texas

Preventing Suicide Among Sexual and Gender Diverse Young Adults in Primary Care in Texas: CRT

The overall aim of this study is to reduce suicide among sexual and gender diverse youth ages 18-24 years old. This study will compare the effectiveness of two brief suicide prevention interventions that have been adapted for use with this population to use in primary care via telehealth and will recruit youth from primary care clinics in Texas metropolitan areas. The primary study outcome is suicidal ideation. Each clinic will be randomly assigned to deliver one of the two study interventions.

Study Overview

• Status: Recruiting
• Conditions: Suicidal Ideation; Suicide
• Intervention / Treatment: Other: STAT-PC; Other: YST-III

• Study Type: Interventional
• Enrollment (Estimated): 1485
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Arnold, PhD; Phone Number: 859-562-3751; Email: Liz.Arnold@uky.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • Recruiting
      • Dell Medical School at The University of Texas at Austin
      • Contact: Phillip Schnarrs, PhD
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center
      • Contact: Emily Levy-Kamugisha, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• be aged 18-24 at the time of enrollment
• not have received mental health services in the past 90 days, excluding medication and case management
• English-speaking
• screen positive for suicide risk

Exclusion Criteria:

• are actively suicidal
• have a developmental disability that would preclude them from participating in the study intervention
• who are impaired due to psychosis, mania, or substance use that would prevent them from providing consent.
• Participants will also be excluded at YST-III sites if they are unable to identify a minimum of one support person to participate in the intervention with them

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suicidal Teens Accessing Treatment - Primary Care (STAT-PC); This group will participate in a brief, suicide prevention intervention based on motivational interviewing that focuses on mental health care seeking behavior, problem-solving, and referrals plus brief case management that has been adapted.	Other: STAT-PC; STAT-PC is an adapted version of Suicidal Teens Accessing Treatment after an ED Visit (STAT-ED). It is a brief intervention based on motivational interviewing (MI) that focuses on mental health care seeking behavior, problem-solving, and referrals plus brief case management. The intervention will consist of an initial session with the youth focusing on accessing mental health care plus case management calls. The interventionist will also be available to assist with referrals for connection to other services later during the study period as needed for up to three months. The intervention may include contact with the youth's mental health provider to make sure linkages are made.; Other Names: Suicidal Teens Accessing Treatment - Primary Care
Experimental: Youth-Nominated Support Team (YST-III); This group will participate in a brief, suicide prevention intervention originally developed for youth who have been psychiatrically hospitalized due to a suicide attempt or suicidal ideation that has been adapted.	Other: YST-III; YST-III is an adapted version of Youth-Nominated Support Team for Suicidal Adolescents (YST-II). The intervention is a brief intervention originally developed for youth who have been psychiatrically hospitalized due to a suicide attempt or suicidal ideation (SI). Participants will nominate supportive adults (age 18 and older) from their lives who agree to provide ongoing contact and support for up to 3 months. YST-III will include an introductory session with the youth who will nominate their support persons plus referrals for mental health services. The support persons will receive training and support on how to best support their youth partner and then ongoing calls to support them in working with their youth partner for up to 3 months.; Other Names: Youth-Nominated Support Team- III

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in suicidal ideation as measured by the Adult Suicidal Ideation Questionnaire (ASIQ)	ASIQ is a 25-item, self-report assessment of suicidal thoughts designed specifically for adult populations. Possible scores range from 1 (Not at All) to 6 (Extreme), with lower scores indicating less severe suicidal ideation (better outcome).	baseline and months 1, 3, 6, 9, and 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of mental healthcare service utilization as measured by Emergency Department Screen for Teens at Risk for Suicide (ED-STARS) mental health service utilization check list	ED-STARS mental health service utilization check list will be used to assess the number of different types of mental health services that participants receive	baseline and months 1, 3, 6, 9, and 12
Change in number of suicide attempts	measured by the number of suicide attempts using the Columbia-Suicide Severity Rating Scale (CSSRS)	baseline and months 1, 3, 6, 9, and 12
Deaths by suicide	The data on any reported deaths due to suicide during the study period will be collected.	baseline to study completion up to 12 months
Change in depressive symptoms as measured by Center for Epidemiologic Studies Depression Scale-Revised CESD-R	CESD-R is a 20-item measure of depression that assesses the duration symptoms across a period of two weeks. Possible scores range from 0-60, with lower scores indicating less depressive symptoms (better outcome).	baseline and months 1, 3, 6, 9, and 12
Change in social support as measured by the Multidimensional Scale of Perceived Social Support (MSPSS)	12-item measure with three subscales that assesses family, friend, and significant other support. Response categories are on a 7-point Likert-scale from 1=very strongly disagree to 7=very strongly agree. The overall score will be used to assess change. The 12-item MSPSS scale has a mean continuous score ranging from 1-84. Higher scores indicate greater perceived social support (better outcome).	baseline and months 1, 3, 6, 9, and 12
Change in internalized stigma as measured by Internalized Transphobia Scale (ITS)-adapted	an adapted version of the Internalized Transphobia Scale (ITS). The measure consists of 22 questions. Possible score ranges from 1-4 with lower scores indicating less internalized stigma (better outcome)	baseline and months 1, 3, 6, 9, and 12

Collaborators and Investigators

• Sponsor: Elizabeth Arnold
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Elizabeth Arnold, PhD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: depression; sexual and gender minority youth; Self-Injurious Behavior
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: 86014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be deposited in the Patient-Centered Outcomes Data Repository as required by the funder.
• IPD Sharing Time Frame: By the date that the Final Research Report is accepted by the funder
• IPD Sharing Access Criteria: Researchers must go through the Patient-Centered Outcomes Data Repository to request access to the de-identified data through their process.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No