Suicide Prevention Intervention for Vulnerable Emerging Adult Sexual Minorities

University of Pennsylvania

Status: Completed

Conditions: Suicide

Treatments: Behavioral: Control condition; Behavioral: STARS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05018143

849500

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

64 participants in 2 patient groups

STARS

Experimental group

Description:

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.

Treatment:

Behavioral: STARS

Control Condition

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control condition