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

Primary Purpose

Suicide, Suicidal Ideation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STAT-PC
YST-III
Sponsored by
Elizabeth Arnold
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring depression, Self-Injurious Behavior, sexual and gender minority youth

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dell Medical School at the University of Texas at AustinRecruiting
  • University of Texas Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Suicidal Teens Accessing Treatment - Primary Care (STAT-PC)

Youth-Nominated Support Team (YST-III)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
Change in number of suicide attempts
measured by the number of suicide attempts using the Columbia-Suicide Severity Rating Scale (CSSRS)
Deaths by suicide
The data on any reported deaths due to suicide during the study period will be collected.
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).
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).
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)

Full Information

First Posted
May 11, 2023
Last Updated
August 15, 2023
Sponsor
Elizabeth Arnold
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05869552
Brief Title
Preventing Suicide Among Sexual and Gender Diverse Young Adults in Primary Care in Texas
Official Title
Preventing Suicide Among Sexual and Gender Diverse Young Adults in Primary Care in Texas: CRT
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elizabeth Arnold
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicidal Ideation
Keywords
depression, Self-Injurious Behavior, sexual and gender minority youth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1485 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Suicidal Teens Accessing Treatment - Primary Care (STAT-PC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Youth-Nominated Support Team (YST-III)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
STAT-PC
Other Intervention Name(s)
Suicidal Teens Accessing Treatment - Primary Care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
YST-III
Other Intervention Name(s)
Youth-Nominated Support Team- III
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in suicidal ideation as measured by the Adult Suicidal Ideation Questionnaire (ASIQ)
Description
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).
Time Frame
baseline and months 1, 3, 6, 9, and 12
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
baseline and months 1, 3, 6, 9, and 12
Title
Change in number of suicide attempts
Description
measured by the number of suicide attempts using the Columbia-Suicide Severity Rating Scale (CSSRS)
Time Frame
baseline and months 1, 3, 6, 9, and 12
Title
Deaths by suicide
Description
The data on any reported deaths due to suicide during the study period will be collected.
Time Frame
baseline to study completion up to 12 months
Title
Change in depressive symptoms as measured by Center for Epidemiologic Studies Depression Scale-Revised CESD-R
Description
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).
Time Frame
baseline and months 1, 3, 6, 9, and 12
Title
Change in social support as measured by the Multidimensional Scale of Perceived Social Support (MSPSS)
Description
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).
Time Frame
baseline and months 1, 3, 6, 9, and 12
Title
Change in internalized stigma as measured by Internalized Transphobia Scale (ITS)-adapted
Description
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)
Time Frame
baseline and months 1, 3, 6, 9, and 12

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
To enroll, participants must identify as a sexual or gender minority individual (i.e., LGBTQ+) and be a patient of the one the clinic sites
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Arnold, PhD
Phone
859-562-3751
Email
Liz.Arnold@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Arnold, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dell Medical School at the University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phillip Schnarrs, PhD
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Levy-Kamugisha, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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