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NCT Number: NCT05869552

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

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 multiple metropolitan areas. The primary study outcome is suicidal ideation. Each clinic will be randomly assigned to deliver one of the two study interventions.

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Coitus Depression Self-Injurious Behavior Sexual Behavior Suicidal Ideation

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh, Pittsburgh, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STAT-PC

Other

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

YST-III

Other

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

Primary outcomes

  1. Change in suicidal ideation as measured by the Adult Suicidal Ideation Questionnaire (ASIQ)

    Time frame: baseline and months 1, 3, 6

    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 outcomes

  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

    Time frame: baseline and months 1, 3, 6

    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

    Time frame: baseline and months 1, 3, 6

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

  3. Deaths by suicide

    Time frame: baseline to 6 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

    Time frame: baseline and months 1, 3, 6

    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)

    Time frame: baseline and months 1, 3, 6

    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

    Time frame: baseline and months 1, 3, 6

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Arnold, PhD

CONTACT

[email protected]

859-562-3751

Sponsors and collaborators

Lead sponsor

Elizabeth Arnold

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 22, 2023
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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