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

Sponsor
Elizabeth Arnold (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05869552
Collaborator
Patient-Centered Outcomes Research Institute (Other)
1,485
2
2
38
742.5
19.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: STAT-PC
  • Other: YST-III
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1485 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Preventing Suicide Among Sexual and Gender Diverse Young Adults in Primary Care in Texas: CRT
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Change in suicidal ideation as measured by the Adult Suicidal Ideation Questionnaire (ASIQ) [baseline and months 1, 3, 6, 9, and 12]

      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

    1. 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 [baseline and months 1, 3, 6, 9, and 12]

      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

    2. Change in number of suicide attempts [baseline and months 1, 3, 6, 9, and 12]

      measured by the number of suicide attempts using the Columbia-Suicide Severity Rating Scale (CSSRS)

    3. Deaths by suicide [baseline to study completion up to 12 months]

      The data on any reported deaths due to suicide during the study period will be collected.

    4. Change in depressive symptoms as measured by Center for Epidemiologic Studies Depression Scale-Revised CESD-R [baseline and months 1, 3, 6, 9, and 12]

      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).

    5. Change in social support as measured by the Multidimensional Scale of Perceived Social Support (MSPSS) [baseline and months 1, 3, 6, 9, and 12]

      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).

    6. Change in internalized stigma as measured by Internalized Transphobia Scale (ITS)-adapted [baseline and months 1, 3, 6, 9, and 12]

      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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 24 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dell Medical School at the University of Texas at Austin Austin Texas United States 78712
    2 University of Texas Southwestern Medical Center Dallas Texas United States 75390

    Sponsors and Collaborators

    • Elizabeth Arnold
    • Patient-Centered Outcomes Research Institute

    Investigators

    • Principal Investigator: Elizabeth Arnold, PhD, University of Kentucky

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elizabeth Arnold, Professor, University of Kentucky
    ClinicalTrials.gov Identifier:
    NCT05869552
    Other Study ID Numbers:
    • 86014
    First Posted:
    May 22, 2023
    Last Update Posted:
    May 22, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Elizabeth Arnold, Professor, University of Kentucky
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 22, 2023