Suicide Prevention Intervention for Vulnerable Emerging Adult Sexual Minorities

NCT05018143 | Completed Results DMC

• 1 other identifier: 849500
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Emerging adult sexual minorities (EASM) are vulnerable to stressors that increase risk for suicidal ideation and behaviors. The investigators will examine a mobile application that leverages skills coaching and peer mentoring to reduce suicide risk for EASM. The online life skills intervention (iREACH) was developed to reduce a variety of negative health outcomes using telehealth with peer mentors. In Supporting Transitions to Adulthood and Reducing Suicide (STARS), investigators' interdisciplinary team will adapt iREACH to reduce suicidal ideation and behaviors among EASM. Then, investigators will pilot test STARS using in a racially/ethnically diverse sample of EASM with suicidal ideation. Participants will be randomized to receive an in-person brief, evidence-based safety planning protocol or to receive safety planning plus access to STARS. This project will identify the potential clinical utility of STARS for suicide prevention in a vulnerable, marginalized, population to inform a future larger efficacy RCT.

Conditions

Suicide

Keywords

Sexual minority; Suicide; Emerging adults

Outcome Measures

Primary Outcomes (1)

• Suicidal Ideation and Behavior

  The Columbia-Suicide Severity Rating Scale is an interview-rated measure that will be completed by a blind independent evaluator. The Columbia-Suicide Severity Rating Scale includes a measure of suicidal ideation (range 0-5: higher scores indicate more severe ideation). The measure has strong psychometric properties, including inter-rater reliability and internal consistency. The suicidal behavior and the suicidal ideation subscales have been shown to predict future suicidal behavior.

  Change from baseline to 6 months

Secondary Outcomes (3)

• Social Support

  Change from baseline to 6 months

• Number of Participants Who Used Their Safety Plant at Least 1 Time

  Every 2 months until 6 months

• Beck Scale for Suicide Ideation

  Change from baseline to 6 months

Study Arms (2)

STARS

EXPERIMENTAL

The investigators will deliver an online intervention focused on safety planning (STARS). The intervention content includes life skills interactive modules across 14 domains, a goal tracker, referral to community resources, and scheduling of peer mentoring sessions.

Behavioral: STARS

Control Condition

ACTIVE COMPARATOR

The investigators will deliver an in-person therapeutic session where participants can develop an individualized safety plan for use during a suicidal crisis, focusing on adaptive coping, addressing barriers or ambivalence, and strengthening their self-efficacy.

Behavioral: Control condition

Interventions

STARS BEHAVIORAL

This intervention will use an online mobile application for teach life skills, coupled with peer mentoring to support the use of safety planning.

STARS

Control condition BEHAVIORAL

In this intervention, participants will receive the safety planning intervention.

Control Condition

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Identifies as a sexual minority
• Lives in the Philadelphia Metropolitan Area;
• Report suicide ideation in the prior month as verified in clinical interview;
• Is aged 18-24 years (inclusive)
• Daily use of a smartphone
• Does not plan to move out of the region for the next 6 months
• Consents to the study procedures

You may not qualify if:

• Does not live in the Philadelphia Metropolitan Area;
• Does not meet clinical criteria for suicide ideation in the prior month;
• Is not between the ages of 18-24 years (inclusive)
• Does not own a smartphone
• Plan to move out of the region for the next 6 months
• Does not consent to study procedures
• Meets criteria for an unmanaged psychotic disorder

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pennsylvania, Center for the Treatment and Study of Anxiety

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Tran JT, Webster J, Wolfe JR, Ben Nathan J, Mayinja L, Kautz M, Oquendo MA, Brown GK, Mandell D, Mowery D, Bauermeister JA, Brown LA. Experiences of Peer Mentoring Sexual and Gender Minority Emerging Adults Who Are at Risk for Suicide: Mixed Methods Study. JMIR Form Res. 2025 Jan 29;9:e67814. doi: 10.2196/67814.

  PMID: 39879591 DERIVED

• Brown LA, Webster JL, Tran JT, Wolfe JR, Golinkoff J, Patel E, Arcomano AC, Ben Nathan J, Azat O'Connor A, Zhu Y, Oquendo M, Brown GK, Mandell D, Mowery D, Bauermeister JA. A Suicide Prevention Intervention for Emerging Adult Sexual and Gender Minority Groups: Protocol for a Pilot Hybrid Effectiveness Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 29;12:e48177. doi: 10.2196/48177.

  PMID: 37773618 DERIVED

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. José A. Bauermeister
• Organization: University of Pennsylvania

bjose@upenn.edu

215-898-3242

Study Officials

• José A Bauermeister, PhD, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes evaluator will be blinded to randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Family & Community Health

Model Details: The investigators will adapt a life skills intervention to increase the desire to live and reduce suicide ideation among at-risk emerging adult sexual minorities (EASM). STARS will embed components of the Safety Plan Intervention and modules to promote coping with discrimination, social support, and positive affect. We will pilot test STARS in a racially/ethnically diverse sample of 60 EASM who report past-month suicidal ideation. Eligible participants will provide informed consent and complete a Safety Planning Intervention with a licensed clinician. They then will be randomized to the control condition ("CC", n = 30) or STARS (n = 30). The investigators will follow participants for 6 months, with evaluations at 2, 4, and 6 months. Primary outcomes will be preliminary efficacy outcomes of suicidal ideation and behavior and hypothesized mechanisms of change (improved coping with discrimination, social support, positive affect) to estimate critical parameters for a future trial.

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 24, 2021
• Study Start: October 20, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The investigators will upload initial data 6 months after the onset of data collection with regular additions approximately every 6 months.

Locations

US (1)