Clinical trial NCT05270785: Preventing Suicide Among Sexual and Gender Diverse Young Adults in Primary Care in Texas
Official title: Preventing Suicide Among Sexual and Gender Diverse Young Adults in Primary Care in Texas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Suicidal Ideation
Keywords: suicidal ideation
depression
suicide
sexual and gender minority youth
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2022-03-08
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in suicidal ideation as measured by ASIQ
timeFrame: Baseline, 2 months
Secondary outcomes:
measure: Change in number of mental healthcare service utilization as measured by ED-STARS mental health service utilization check list
timeFrame: Baseline, 2 months
measure: Number of past 2 months suicide attempts at baseline
timeFrame: Baseline
measure: Number of lifetime suicide attempts at baseline
timeFrame: Baseline
measure: Number of suicide attempts at 2 months
timeFrame: 2 months
measure: Change in depressive symptoms as measured by CESD-R
timeFrame: Baseline, 2 months
measure: Change in social support as measured by MSPSS
timeFrame: Baseline, 2 months
measure: Change in internalized stigma as measured by ITS-adapted
timeFrame: Baseline, 2 months
measure: Number of deaths by suicide at 2 months
timeFrame: 2 months
Other outcomes:
measure: Number of participants who had access to means for suicide at baseline
timeFrame: Baseline
measure: Number of participants who had access to means for suicide at 2 months
timeFrame: 2 months
measure: Proportion of participants who screened and met criteria
timeFrame: Last day of study recruitment period (approx. week 14)
measure: Proportion of participants who enrolled in the study
timeFrame: Last day of study recruitment period (approx. week 14)
measure: Number of participants who decide not to participate
timeFrame: 2 months post-intervention
measure: Intervention acceptability
timeFrame: 1 month post-intervention
measure: Study feasibility
timeFrame: 1 month post-intervention
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Elizabeth Arnold, PhD
role: PRINCIPAL_INVESTIGATOR
References: