Suicidal IdeationNCT05270785
Preventing Suicide Among Sexual and Gender Diverse Young Adults in Primary Care in Texas
A study testing STAT-PC and YST-III in people with Suicidal Ideation, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The aim of this pilot study is to reduce suicide among sexual and gender diverse youth ages 18-24 years old. This pilot study will compare two brief suicide prevention interventions that have been adapted for use with this population to use in primary care via telehealth and will recruit 40 youth from 4-6 primary care… Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- 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
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2022to 20 Dec 2022
- Phase
- Interventional
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; and
- not have received mental health services in the past 90 days, excluding medication;
- English-speaking, and
- screen positive for suicidal ideation.
Who cannot join
- are actively suicidal
- have a developmental disability that would preclude them from participating in the study intervention or
- 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.
- Those who are excluded will be provided with referrals for treatment services.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this pilot study is to reduce suicide among sexual and gender diverse youth ages 18-24 years old. This pilot study will compare two brief suicide prevention interventions that have been adapted for use with this population to use in primary care via telehealth and will recruit 40 youth from 4-6 primary care clinics in the Dallas and Austin, Texas metropolitan areas. Each clinic will be randomly assigned to deliver one of the two study interventions.
Read the detailed description
This is a cluster randomized study focused on youth suicide prevention which will recruit 40 youth from four primary care clinics serving sexual and gender diverse young adults in the Dallas and Austin, TX metropolitan areas. Each clinic will recruit 10 youth. Two clinics will be randomly assigned to deliver each of the two study interventions. The interventions are adapted versions of two existing, brief suicide prevention interventions: 1) Suicidal Teens Accessing Treatment after an ED Visit (STAT-ED) is a brief intervention based on motivational interviewing that focuses on mental health care seeking behavior, problem-solving, and referrals plus brief case management; and 2) Youth-Nominated Support Team for Suicidal Adolescents (YST-II) is a brief intervention developed for youth who have been psychiatrically hospitalized due to a suicide attempt or suicidal ideation. The revised interventions will be called STAT-PC and YST-III. For YST III, participants will identify 1-2 supportive adults from their lives who agree to provide ongoing contact and support. The interventions will last two months. Primary and secondary outcome assessments will be done at baseline and/or at 2 months.
To be eligible, participants must report risk factors for suicide based on screening questions that will be implemented in our primary clinic sites.
- Conditions
- Suicidal Ideation
- Being tested
- STAT-PC, YST-III
- Keywords
- suicidal ideation, depression, suicide, sexual and gender minority youth
- Medical subject headings
- Suicidal Ideation, Depression, Suicide, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAT-PCOther
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 (2-3 follow-up calls). The intervention will consist of an initial session with the youth focusing on accessing mental health care plus two 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 two months. The intervention may include contact with the youth's mental health provider to make sure linkages are made.
YST-IIIOther
YST-III is an adapted version of Youth-Nominated Support Team for Suicidal Adolescents (YST-II). The intervention is a brief intervention developed for youth who have been psychiatrically hospitalized due to a suicide attempt or suicidal ideation (SI). Participants will nominate 1-2 supportive adults (age 18 and older) from their lives who agree to provide ongoing contact and support for up to 2 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 on how to best support their youth partner and then ongoing calls to support them in working with their youth partner for up to 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Suicidal Teens Accessing Treatment - Primary Care (STAT-PC) | Experimental | This group will undergo 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 Receives: Other: STAT-PC |
| Youth-Nominated Support Team (YST-III) | Experimental | This group will undergo 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 ASIQ
Change in suicidal ideation is measured by Adult Suicidal Ideation Questionnaire (ASIQ). It 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, 2 months
Secondary outcomes (8)
Change in number of mental healthcare service utilization as measured by ED-STARS mental health service utilization check list
Change in number of mental healthcare service utilization is measured by Emergency Department Screen for Teens at Risk for Suicide (ED-STARS) mental health service utilization check list which will be used to assess the number of different types of mental health services that participants receive including inpatient psychiatric services, emergency department visits, medication management, and psychotherapy/counseling.
Measured: Baseline, 2 months
Number of past 2 months suicide attempts at baseline
Past 2 months suicide attempts is measured by suicide attempt question from the Columbia-Suicide Severity Rating Scale (CSSRS) which will assess the number of suicide attempts.
Measured: Baseline
Number of lifetime suicide attempts at baseline
Suicide attempts is measured by suicide attempt question from the Columbia-Suicide Severity Rating Scale (CSSRS) which will assess the number of suicide attempts.
Measured: Baseline
Number of suicide attempts at 2 months
Suicide attempts is measured by suicide attempt questions from the Columbia-Suicide Severity Rating Scale (CSSRS) which will assess the number of suicide attempts.
Measured: 2 months
Change in depressive symptoms as measured by CESD-R
Change in depressive symptoms is measured by Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) which 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, 2 months
Change in social support as measured by MSPSS
Change in social support is measured by Multidimensional Scale of Perceived Social Support (MSPSS) which is a 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, 2 months
Change in internalized stigma as measured by ITS-adapted
Change in internalized stigma is measured by Internalized Transphobia Scale (ITS) - adapted. Internalized stigma will be measured by 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, 2 months
Number of deaths by suicide at 2 months
The data on any reported deaths due to suicide during the study period will be collected.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start25 Jul 2022
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Why it stopped: Lack of eligible participants during study time period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Elizabeth Arnold, University of Texas Southwestern Medical Center
- Investigators
- Elizabeth Arnold, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270785
- Sponsor's protocol ID
- STU-2022-0351
- Other IDs
- SP-2020C3-210
- Status last verified
- Jan 2023
- First submitted
- 25 Feb 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No