Skip to main content
Clinical Trials/NCT05018143
NCT05018143
Completed
N/A

Suicide Prevention Intervention for Vulnerable Emerging Adult Sexual Minorities

University of Pennsylvania1 site in 1 country64 target enrollmentOctober 20, 2022
ConditionsSuicide

Overview

Phase
N/A
Intervention
Not specified
Conditions
Suicide
Sponsor
University of Pennsylvania
Enrollment
64
Locations
1
Primary Endpoint
Suicidal Ideation and Behavior
Status
Completed
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2022
End Date
August 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jose Bauermeister

Chair, Department of Family & Community Health

University of Pennsylvania

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Suicidal Ideation and Behavior

Time Frame: Change from baseline to 6 months

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.

Secondary Outcomes

  • 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 Sites (1)

Loading locations...

Similar Trials