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

NCT05869552 | Recruiting DMC

• 2 other identifiers: 86014SP-2020C3-21020-IC
• Study Type: interventional
• Target: 1,485
• Locations: 1 country
• Sites: 3

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

Conditions

Suicide; Suicidal Ideation

Keywords

depression; Self-Injurious Behavior; sexual and gender minority youth

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

• Change in number of suicide attempts

  baseline and months 1, 3, 6

• Deaths by suicide

  baseline to 6 months

• Change in depressive symptoms as measured by Center for Epidemiologic Studies Depression Scale-Revised CESD-R

  baseline and months 1, 3, 6

• Change in social support as measured by the Multidimensional Scale of Perceived Social Support (MSPSS)

  baseline and months 1, 3, 6

Study Arms (2)

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

EXPERIMENTAL

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

Youth-Nominated Support Team (YST-III)

EXPERIMENTAL

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

Interventions

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.

Also known as: Suicidal Teens Accessing Treatment - Primary Care

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

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.

Also known as: Youth-Nominated Support Team- III

Youth-Nominated Support Team (YST-III)

Eligibility Criteria

• Age: 18 Years - 24 Years
• Gender Eligibility Details: 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
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elizabeth Arnold: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (3)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

RECRUITING

Steve Hicks School of Social Work at the University of Texas at Austin

Austin, Texas, 78705, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Suicide; Suicidal Ideation; Depression; Self-Injurious Behavior; Coitus

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sexual Behavior

Study Officials

• Elizabeth Arnold, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Arnold, PhD

CONTACT

859-562-3751; Liz.Arnold@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: July 13, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: By the date that the Final Research Report is accepted by the funder
• Access Criteria: Researchers must go through the Patient-Centered Outcomes Data Repository to request access to the de-identified data through their process.

Locations

US (3)