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Completed

NCT Number: NCT05018143

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.

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Self-Injurious Behavior

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control condition

Behavioral

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

Primary outcomes

  1. 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

  1. Social Support

    Time frame: Change from baseline to 6 months

    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.

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

    Time frame: Every 2 months until 6 months

    Self-reported use of their safety plan

  3. Beck Scale for Suicide Ideation

    Time frame: Change from baseline to 6 months

    Sum of self-reported suicide ideation, with a possible range from 0 - 38, with higher values reflecting greater severity of suicidal ideation.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 24, 2021
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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