Clinical trial NCT05869552: 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: CRT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide
Suicidal Ideation
Keywords: depression
Self-Injurious Behavior
sexual and gender minority youth
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2023-05-22
Enrollment: 1485
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 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 Texas metropolitan areas. The primary study outcome is suicidal ideation. Each clinic will be randomly assigned to deliver one of the two study interventions.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Change in suicidal ideation as measured by the Adult Suicidal Ideation Questionnaire (ASIQ)
timeFrame: baseline and months 1, 3, 6, 9, and 12
Secondary outcomes:
measure: 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
timeFrame: baseline and months 1, 3, 6, 9, and 12
measure: Change in number of suicide attempts
timeFrame: baseline and months 1, 3, 6, 9, and 12
measure: Deaths by suicide
timeFrame: baseline to study completion up to 12 months
measure: Change in depressive symptoms as measured by Center for Epidemiologic Studies Depression Scale-Revised CESD-R
timeFrame: baseline and months 1, 3, 6, 9, and 12
measure: Change in social support as measured by the Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: baseline and months 1, 3, 6, 9, and 12
measure: Change in internalized stigma as measured by Internalized Transphobia Scale (ITS)-adapted
timeFrame: baseline and months 1, 3, 6, 9, and 12
Other outcomes:
Locations:
city: Austin
country: United States
facility: Steve Hicks School of Social Work at the University of Texas at Austin
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Kentucky
name: Elizabeth Arnold, PhD
role: PRINCIPAL_INVESTIGATOR
References: