Clinical trial NCT05018143: Suicide Prevention Intervention for Vulnerable Emerging Adult Sexual Minorities
Official title: Suicide Prevention Intervention for Vulnerable Emerging Adult Sexual Minorities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: Sexual minority
Suicide
Emerging adults
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-08-24
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Suicidal Ideation and Behavior
timeFrame: Change from baseline to 6 months
Secondary outcomes:
measure: Social Support
timeFrame: Change from baseline to 6 months
measure: Number of Participants Who Used Their Safety Plant at Least 1 Time
timeFrame: Every 2 months until 6 months
measure: Beck Scale for Suicide Ideation
timeFrame: Change from baseline to 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania, Center for the Treatment and Study of Anxiety
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: José A Bauermeister, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: