Suicide Prevention Intervention for Vulnerable Emerging Adult Sexual Minorities

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.

Study Overview

• Status: Completed
• Conditions: Suicide
• Intervention / Treatment: Behavioral: STARS; Behavioral: Control condition

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania, Center for the Treatment and Study of Anxiety

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: STARS; This intervention will use an online mobile application for teach life skills, coupled with peer mentoring to support the use of safety planning.
Active Comparator: 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.	Behavioral: Control condition; In this intervention, participants will receive the safety planning intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Support	Support from family respectively, will be measured through the Procidano and Heller Perceived Social Support from Family Scale. This five-item emotional support scale is rated on a 5-point scale (1=Not True; 5=Very True), where higher scores indicate greater social support. The measure has strong convergent and divergent validity, as well a strong test-retest reliability and internal consistency.	Change from baseline to 6 months
Number of Participants Who Used Their Safety Plant at Least 1 Time	Self-reported use of their safety plan	Every 2 months until 6 months
Beck Scale for Suicide Ideation	Sum of self-reported suicide ideation, with a possible range from 0 - 38, with higher values reflecting greater severity of suicidal ideation.	Change from baseline to 6 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: José A Bauermeister, PhD, MPH, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Suicide; Sexual minority; Emerging adults
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide Prevention; Suicide
• Other Study ID Numbers: 849500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The dataset will be shared with the NIMH Data Archive.
• IPD Sharing Time Frame: The investigators will upload initial data 6 months after the onset of data collection with regular additions approximately every 6 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: GUID

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No