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

Suicide Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05869552
• Other study ID #: 86014
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2023
• Est. completion date: July 2026

Study information

• Verified date: August 2023
• Source: University of Kentucky
• Contact: Elizabeth Arnold, PhD
• Phone: 859-562-3751
• Email: Liz.Arnold[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1485
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Dell Medical School at the University of Texas at Austin	Austin	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Elizabeth Arnold	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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