search
Back to results

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

Primary Purpose

Suicidal Ideation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STAT-PC
YST-III
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation focused on measuring suicidal ideation, depression, suicide, 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; and
  • not have received mental health services in the past 90 days, excluding medication;
  • English-speaking, and
  • screen positive for suicidal ideation.

Exclusion Criteria:

  • are actively suicidal
  • have a developmental disability that would preclude them from participating in the study intervention or
  • 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.

Those who are excluded will be provided with referrals for treatment services.

Sites / Locations

  • UT Southwestern Medical Center

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 undergo 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

This group will undergo 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 ASIQ
Change in suicidal ideation is measured by Adult Suicidal Ideation Questionnaire (ASIQ). It 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 ED-STARS mental health service utilization check list
Change in number of mental healthcare service utilization is measured by Emergency Department Screen for Teens at Risk for Suicide (ED-STARS) mental health service utilization check list which will be used to assess the number of different types of mental health services that participants receive including inpatient psychiatric services, emergency department visits, medication management, and psychotherapy/counseling.
Number of past 2 months suicide attempts at baseline
Past 2 months suicide attempts is measured by suicide attempt question from the Columbia-Suicide Severity Rating Scale (CSSRS) which will assess the number of suicide attempts.
Number of lifetime suicide attempts at baseline
Suicide attempts is measured by suicide attempt question from the Columbia-Suicide Severity Rating Scale (CSSRS) which will assess the number of suicide attempts.
Number of suicide attempts at 2 months
Suicide attempts is measured by suicide attempt questions from the Columbia-Suicide Severity Rating Scale (CSSRS) which will assess the number of suicide attempts.
Change in depressive symptoms as measured by CESD-R
Change in depressive symptoms is measured by Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) which 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 MSPSS
Change in social support is measured by Multidimensional Scale of Perceived Social Support (MSPSS) which is a 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 ITS-adapted
Change in internalized stigma is measured by Internalized Transphobia Scale (ITS) - adapted. Internalized stigma will be measured by 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)
Number of deaths by suicide at 2 months
The data on any reported deaths due to suicide during the study period will be collected.

Full Information

First Posted
February 25, 2022
Last Updated
January 18, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Patient-Centered Outcomes Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT05270785
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Lack of eligible participants during study time period
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
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 aim of this pilot study is to reduce suicide among sexual and gender diverse youth ages 18-24 years old. This pilot study will compare two brief suicide prevention interventions that have been adapted for use with this population to use in primary care via telehealth and will recruit 40 youth from 4-6 primary care clinics in the Dallas and Austin, Texas metropolitan areas. Each clinic will be randomly assigned to deliver one of the two study interventions.
Detailed Description
This is a cluster randomized study focused on youth suicide prevention which will recruit 40 youth from four primary care clinics serving sexual and gender diverse young adults in the Dallas and Austin, TX metropolitan areas. Each clinic will recruit 10 youth. Two clinics will be randomly assigned to deliver each of the two study interventions. The interventions are adapted versions of two existing, brief suicide prevention interventions: 1) Suicidal Teens Accessing Treatment after an ED Visit (STAT-ED) is a brief intervention based on motivational interviewing that focuses on mental health care seeking behavior, problem-solving, and referrals plus brief case management; and 2) Youth-Nominated Support Team for Suicidal Adolescents (YST-II) is a brief intervention developed for youth who have been psychiatrically hospitalized due to a suicide attempt or suicidal ideation. The revised interventions will be called STAT-PC and YST-III. For YST III, participants will identify 1-2 supportive adults from their lives who agree to provide ongoing contact and support. The interventions will last two months. Primary and secondary outcome assessments will be done at baseline and/or at 2 months. To be eligible, participants must report risk factors for suicide based on screening questions that will be implemented in our primary clinic sites.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation
Keywords
suicidal ideation, depression, suicide, 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
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suicidal Teens Accessing Treatment - Primary Care (STAT-PC)
Arm Type
Experimental
Arm Description
This group will undergo 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
Arm Title
Youth-Nominated Support Team (YST-III)
Arm Type
Experimental
Arm Description
This group will undergo 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
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 (2-3 follow-up calls). The intervention will consist of an initial session with the youth focusing on accessing mental health care plus two 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 two 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
Intervention Description
YST-III is an adapted version of Youth-Nominated Support Team for Suicidal Adolescents (YST-II). The intervention is a brief intervention developed for youth who have been psychiatrically hospitalized due to a suicide attempt or suicidal ideation (SI). Participants will nominate 1-2 supportive adults (age 18 and older) from their lives who agree to provide ongoing contact and support for up to 2 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 on how to best support their youth partner and then ongoing calls to support them in working with their youth partner for up to 2 months.
Primary Outcome Measure Information:
Title
Change in suicidal ideation as measured by ASIQ
Description
Change in suicidal ideation is measured by Adult Suicidal Ideation Questionnaire (ASIQ). It 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, 2 months
Secondary Outcome Measure Information:
Title
Change in number of mental healthcare service utilization as measured by ED-STARS mental health service utilization check list
Description
Change in number of mental healthcare service utilization is measured by Emergency Department Screen for Teens at Risk for Suicide (ED-STARS) mental health service utilization check list which will be used to assess the number of different types of mental health services that participants receive including inpatient psychiatric services, emergency department visits, medication management, and psychotherapy/counseling.
Time Frame
Baseline, 2 months
Title
Number of past 2 months suicide attempts at baseline
Description
Past 2 months suicide attempts is measured by suicide attempt question from the Columbia-Suicide Severity Rating Scale (CSSRS) which will assess the number of suicide attempts.
Time Frame
Baseline
Title
Number of lifetime suicide attempts at baseline
Description
Suicide attempts is measured by suicide attempt question from the Columbia-Suicide Severity Rating Scale (CSSRS) which will assess the number of suicide attempts.
Time Frame
Baseline
Title
Number of suicide attempts at 2 months
Description
Suicide attempts is measured by suicide attempt questions from the Columbia-Suicide Severity Rating Scale (CSSRS) which will assess the number of suicide attempts.
Time Frame
2 months
Title
Change in depressive symptoms as measured by CESD-R
Description
Change in depressive symptoms is measured by Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) which 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, 2 months
Title
Change in social support as measured by MSPSS
Description
Change in social support is measured by Multidimensional Scale of Perceived Social Support (MSPSS) which is a 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, 2 months
Title
Change in internalized stigma as measured by ITS-adapted
Description
Change in internalized stigma is measured by Internalized Transphobia Scale (ITS) - adapted. Internalized stigma will be measured by 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, 2 months
Title
Number of deaths by suicide at 2 months
Description
The data on any reported deaths due to suicide during the study period will be collected.
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
Number of participants who had access to means for suicide at baseline
Description
This is a descriptive measure with patient reported Yes/ No responses and if yes, to categorize the means for suicide.
Time Frame
Baseline
Title
Number of participants who had access to means for suicide at 2 months
Description
This is a descriptive measure with patient reported Yes/ No responses and if yes, to categorize the means for suicide.
Time Frame
2 months
Title
Proportion of participants who screened and met criteria
Description
Proportion of participants who screened and met criteria is obtained at the last day of the study recruitment period.
Time Frame
Last day of study recruitment period (approx. week 14)
Title
Proportion of participants who enrolled in the study
Description
Proportion of participants who enrolled in the study is obtained at the last day of the study recruitment period.
Time Frame
Last day of study recruitment period (approx. week 14)
Title
Number of participants who decide not to participate
Description
For potential study candidates who decide not to participate, refusal reason will be logged.
Time Frame
2 months post-intervention
Title
Intervention acceptability
Description
Intervention acceptability will be measured by asking participants to rate the extent to which they agree with 4 statements about the study intervention received on a scale of 1 to 4 where 1 is strongly disagree and 4 is strongly agree
Time Frame
1 month post-intervention
Title
Study feasibility
Description
Study feasibility will be measured by asking participants to rate the extent to which they agree with 5 statements about the study on a scale of 1 to 4 where 1 is strongly disagree and 4 is strongly agree.
Time Frame
1 month post-intervention

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; and not have received mental health services in the past 90 days, excluding medication; English-speaking, and screen positive for suicidal ideation. Exclusion Criteria: are actively suicidal have a developmental disability that would preclude them from participating in the study intervention or 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. Those who are excluded will be provided with referrals for treatment services.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Arnold, PhD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs