Suicide Prevention Intervention for Vulnerable Emerging Adult Sexual Minorities

NCT ID: NCT05018143

Last Updated: 2025-02-17

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-20

Study Completion Date

2024-08-31

Brief Summary

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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.

Detailed Description

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Investigators will use the ADAPT-ITT framework to adapt a life skills intervention to increase the desire to live and reduce suicide ideation among at-risk emerging adult sexual minorities. STARS will embed components of the Safety Plan Intervention as well as modules focused on promoting coping with discrimination, social support, and positive affect. Investigators will pilot test STARS using a Type 1 Effectiveness-Implementation Hybrid Design in a racially/ethnically diverse sample of 60 EASM who report past-month suicidal ideation. Investigators will recruit EASM through social media advertising and invite them to an in-person screening. Eligible participants will provide informed consent and complete a Safety Planning Intervention with a licensed clinician, given the high-risk nature of the sample. They then will be randomized to the control condition ("CC", n = 30) or STARS (n = 30). Participants will be assessed 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. Secondary outcomes will be RE-AIM framework indicators (reach, adoption, implementation, maintenance). Our aims are: Aim 1: To conduct a systematic suicide prevention adaptation of a life skills intervention (STARS) that incorporates safety planning content and targets coping, social support, and positive affect using the ADAPT-ITT framework. Aim 2: To examine preliminary efficacy (suicidal ideation and behaviors) and mechanisms of action of STARS, relative to our control condition (safety planning protocol alone), using a prospective RCT design. Aim 3: Using RE-AIM metrics, to examine whether STARS has preliminary evidence for impacting intervention implementation outcomes among EASM compared to the control arm.

Conditions

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Suicide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes evaluator will be blinded to randomization.

Study Groups

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STARS

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.

Group Type EXPERIMENTAL

STARS

Intervention Type BEHAVIORAL

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

Control Condition

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.

Group Type ACTIVE_COMPARATOR

Control condition

Intervention Type BEHAVIORAL

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

Interventions

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STARS

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

Intervention Type BEHAVIORAL

Control condition

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Jose Bauermeister

Chair, Department of Family & Community Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José A Bauermeister, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39879591 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37773618 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Study Documents

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Document Type: Individual Participant Data Set

View Document

Other Identifiers

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849500

Identifier Type: -

Identifier Source: org_study_id

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