NCT05270785

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

July 25, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

February 25, 2022

Last Update Submit

January 18, 2023

Conditions

Keywords

suicidal ideationdepressionsuicidesexual and gender minority youth

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Change in number of mental healthcare service utilization as measured by ED-STARS mental health service utilization check list

    Baseline, 2 months

  • Number of past 2 months suicide attempts at baseline

    Baseline

  • Number of lifetime suicide attempts at baseline

    Baseline

  • Number of suicide attempts at 2 months

    2 months

  • Change in depressive symptoms as measured by CESD-R

    Baseline, 2 months

  • +3 more secondary outcomes

Other Outcomes (7)

  • Number of participants who had access to means for suicide at baseline

    Baseline

  • Number of participants who had access to means for suicide at 2 months

    2 months

  • Proportion of participants who screened and met criteria

    Last day of study recruitment period (approx. week 14)

  • +4 more other outcomes

Study Arms (2)

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

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

Other: YST-III

Interventions

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.

Suicidal Teens Accessing Treatment - Primary Care (STAT-PC)
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.

Youth-Nominated Support Team (YST-III)

Eligibility Criteria

Age18 Years - 24 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsTo enroll, participants must identify as a sexual or gender minority individual (i.e., LGBTQ+) and be a patient of the one the clinic sites
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Suicidal IdeationDepressionSuicideCoitus

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorSexual Behavior

Study Officials

  • Elizabeth Arnold, PhD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 25, 2022

First Posted

March 8, 2022

Study Start

July 25, 2022

Primary Completion

December 20, 2022

Study Completion

December 20, 2022

Last Updated

January 20, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations