ClinicalTrials.gg
RecruitingNCT05869552Updated Nov 6, 2025

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

An interventional study of STAT-PC and YST-III in Suicide and Suicidal Ideation, sponsored by Elizabeth Arnold. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2025-11-06.

Primary conditionSuicidal IdeationRegistry: SuicideReclassifiedWhy we changed it
Registry
Suicide — the first condition term the registry derived for this study.
ClinicalTrials.gg
Suicidal Ideation
Why
  1. Suicide is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Suicidal Ideation, a narrower term within Suicide.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Elizabeth Arnold · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,485
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 349 studies in Suicidal Ideation with a site in United States — 109 open to participants now, 122 under way, 4 of them phase 3. Suicidal Ideation · United States.

Planned enrollment
12th of 320
1,485 · median 66
Started
2023
with 33 others
No phase
254 of 349
93 open now
Primary completion
2027-03
later than 44 of 121 live
Registered
241st of 349
by date

Among the 349 studies in Suicidal Ideation with a site in United States, this one is the 12th largest by planned enrollment of the 320 interventional ones, is one of 34 that started in 2023, is one of 254 with no phase, reaches primary completion later than 44 of the 121 other live ones, and was the 241st registered.

By phase

349 studies; the count open now beside each. This study's row is marked.

No phasethis study254 · 93 open
Observational29 · 5 open
Phase 216 · 4 open
Phase 416 · 1 open
Phase 113 · 5 open
Phase 310 · 0 open
Phase 2/38 · 1 open
Phase 1/23 · 0 open

By the year they started

First in 2004; this study’s year is marked. 34 started in 2023.

Size and results

Median enrollment 66 across the 320 interventional studies, 133 across the 29 observational. Of the 198 that completed or were terminated, 82 (41%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 349 studies in Suicidal Ideation with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Suicide
  • Suicidal Ideation

Browse trials for

Keywords

  • depression
  • Self-Injurious Behavior
  • sexual and gender minority youth
04

In context

Suicidal Ideation Reclassified

569 studies on the registry are indexed under Suicidal Ideation; 203 are open to participants now.

This study's planned enrollment of 1,485 is above the median of 80 across 469 interventional studies indexed under Suicidal Ideation.

Browse Suicidal Ideation studies →

Lead sponsor

Elizabeth Arnold is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Compared within Suicidal Ideation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Suicide. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
06

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,485 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherSTAT-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.

    Also known as: Suicidal Teens Accessing Treatment - Primary Care

  • OtherYST-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.

    Also known as: Youth-Nominated Support Team- III

07

What researchers measure

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).

    Time frame: baseline and months 1, 3, 6

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

    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

  2. Change in number of suicide attempts

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

    Time frame: baseline and months 1, 3, 6

  3. Deaths by suicide

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

    Time frame: baseline to 6 months

  4. 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).

    Time frame: baseline and months 1, 3, 6

  5. 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).

    Time frame: baseline and months 1, 3, 6

  6. 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)

    Time frame: baseline and months 1, 3, 6

08

Study locations

3 of 3 sites recruiting
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15261, United States
    Recruiting
    • Phillip Schnarrs, PhD · Contact
  • Steve Hicks School of Social Work at the University of Texas at Austin
    Austin, Texas 78705, United States
    Recruiting
    • Lauren Gulbas, PhD · Contact
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
    Recruiting
    • Emily Levy-Kamugisha, MD · Contact
09

References and documents

Individual participant data

Plan to share: Yes — De-identified data will be deposited in the Patient-Centered Outcomes Data Repository as required by the funder.

Supporting information: 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.

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2023 (actual). Primary completion is estimated for Mar 2027, 44 months after the start.

Of 281 non-industry interventional studies with no phase under Suicidal Ideation, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 44 months is above that.

Counting every sponsor, half of 290 studies reached it within 29 months; a quarter within 13 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
May 11, 2023
First posted
May 22, 2023
StartActual
Jul 13, 2023
Primary completionEst.
Mar 2027
CompletionEst.
Mar 2027
Last update
Nov 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05869552
Lead sponsor
Elizabeth Arnold
Collaborators
Patient-Centered Outcomes Research Institute
Responsible party
Elizabeth Arnold (Professor, University of Kentucky) — Sponsor-investigator
First posted
May 22, 2023
Start date
Jul 13, 2023
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Nov 6, 2025

Study contacts

Elizabeth Arnold, PhD
Contact
Liz.Arnold@uky.edu
859-562-3751
Elizabeth Arnold, PhD
principal investigator · University of Kentucky

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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