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

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05270785
• Other study ID #: STU-2022-0351
• Secondary ID: SP-2020C3-210
• Status: Terminated
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: January 2023
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 clinics in the Dallas and Austin, Texas metropolitan areas. Each clinic will be randomly assigned to deliver one of the two study interventions.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide

Intervention

Other:
• STAT-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 (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-III
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.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants who had access to means for suicide at baseline	This is a descriptive measure with patient reported Yes/ No responses and if yes, to categorize the means for suicide.	Baseline
Other	Number of participants who had access to means for suicide at 2 months	This is a descriptive measure with patient reported Yes/ No responses and if yes, to categorize the means for suicide.	2 months
Other	Proportion of participants who screened and met criteria	Proportion of participants who screened and met criteria is obtained at the last day of the study recruitment period.	Last day of study recruitment period (approx. week 14)
Other	Proportion of participants who enrolled in the study	Proportion of participants who enrolled in the study is obtained at the last day of the study recruitment period.	Last day of study recruitment period (approx. week 14)
Other	Number of participants who decide not to participate	For potential study candidates who decide not to participate, refusal reason will be logged.	2 months post-intervention
Other	Intervention acceptability	Intervention acceptability will be measured by asking participants to rate the extent to which they agree with 4 statements about the study intervention received on a scale of 1 to 4 where 1 is strongly disagree and 4 is strongly agree	1 month post-intervention
Other	Study feasibility	Study feasibility will be measured by asking participants to rate the extent to which they agree with 5 statements about the study on a scale of 1 to 4 where 1 is strongly disagree and 4 is strongly agree.	1 month post-intervention
Primary	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)	Baseline, 2 months
Secondary	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.	Baseline, 2 months
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	2 months
Secondary	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).	Baseline, 2 months
Secondary	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).	Baseline, 2 months
Secondary	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)	Baseline, 2 months
Secondary	Number of deaths by suicide at 2 months	The data on any reported deaths due to suicide during the study period will be collected.	2 months