SuicideNCT05869552
Preventing Suicide Among Sexual and Gender Diverse Young Adults in Primary Care
A study testing STAT-PC and YST-III in people with Suicide and Suicidal Ideation, run by Elizabeth Arnold at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Suicide, Suicidal Ideation
- What is being tested?
- STAT-PC and YST-III
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,485 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Jul 2023to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Steve Hicks School of Social Work at the University of Texas at Austin
Austin, Texas, 78705
Lauren Gulbas, PhD
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Emily Levy-Kamugisha, MD
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Phillip Schnarrs, PhD
About this study
Official title: Preventing Suicide Among Sexual and Gender Diverse Young Adults in Primary Care: CRT
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
- Being tested
- STAT-PC, YST-III
- Keywords
- depression, Self-Injurious Behavior, sexual and gender minority youth
- Medical subject headings
- Suicide, Suicidal Ideation, Depression, Self-Injurious Behavior, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAT-PCOther
Also called Suicidal Teens Accessing Treatment - Primary Care
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.
YST-IIIOther
Also called Youth-Nominated Support Team- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: YST-III |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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
Measured: baseline and months 1, 3, 6
Change in number of suicide attempts
measured by the number of suicide attempts using the Columbia-Suicide Severity Rating Scale (CSSRS)
Measured: baseline and months 1, 3, 6
Deaths by suicide
The data on any reported deaths due to suicide during the study period will be collected.
Measured: baseline to 6 months
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).
Measured: baseline and months 1, 3, 6
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).
Measured: baseline and months 1, 3, 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)
Measured: baseline and months 1, 3, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start13 Jul 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,485 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elizabeth Arnold
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor-investigator, Elizabeth Arnold, University of Kentucky
- Investigators
- Elizabeth Arnold, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869552
- Sponsor's protocol ID
- 86014
- Other IDs
- SP-2020C3-21020-IC
- Status last verified
- Nov 2025
- First submitted
- 11 May 2023
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be deposited in the Patient-Centered Outcomes Data Repository as required by the funder.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Suicide Among Sexual and Gender Diverse Young Adults in Primary Care: CRT
- ClinicalTrials.gov ID
- NCT05869552
- Acronym / sponsor ID
- 86014
- Conditions
- Suicide, Suicidal Ideation
- Keywords
- depression, Self-Injurious Behavior, sexual and gender minority youth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,485 participants (estimated)
- Lead sponsor
- Elizabeth ArnoldUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suicidal Teens Accessing Treatment - Primary Care (STAT-PC) | Experimental | Other: STAT-PCThis 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. |
| Youth-Nominated Support Team (YST-III) | Experimental | Other: YST-IIIThis 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAT-PCAlso: Suicidal Teens Accessing Treatment - Primary CareSTAT-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 | Suicidal Teens Accessing Treatment - Primary Care (STAT-PC) |
| YST-IIIAlso: Youth-Nominated Support Team- IIIYST-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 | Youth-Nominated Support Team (YST-III) |
Primary outcome
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).
6 secondary outcomes
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
Change in number of suicide attempts
Time frame: baseline and months 1, 3, 6
Deaths by suicide
Time frame: baseline to 6 months
Change in depressive symptoms as measured by Center for Epidemiologic Studies Depression Scale-Revised CESD-R
Time frame: baseline and months 1, 3, 6
Change in social support as measured by the Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: baseline and months 1, 3, 6
Change in internalized stigma as measured by Internalized Transphobia Scale (ITS)-adapted
Time frame: baseline and months 1, 3, 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Individual participant dataSharing planned: Yes. De-identified data will be deposited in the Patient-Centered Outcomes Data Repository as required by the funder.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Arnold, PhD principal investigator
University of Kentucky
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAT-PC and YST-III in people with Suicide and Suicidal Ideation, run by Elizabeth Arnold at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Arnold, PhD (859-562-3751, Liz.Arnold@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in suicidal ideation as measured by the Adult Suicidal Ideation Questionnaire (ASIQ) (time frame: baseline and months 1, 3, 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.