Suicide Prevention Intervention for Vulnerable Emerging Adult Sexual Minorities

Suicide Clinical Trial

Official title:

Suicide Prevention Intervention for Vulnerable Emerging Adult Sexual Minorities

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05018143
• Other study ID #: 849500
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: August 31, 2024
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Suicide
• Suicide Prevention

Intervention

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.
• Control condition
In this intervention, participants will receive the safety planning intervention.

Locations

Country	Name	City	State
United States	University of Pennsylvania, Center for the Treatment and Study of Anxiety	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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) and intensity (range 0-4: higher scores greater ideation severity), and suicidal behavior (count of total number of actual, interrupted, and aborted attempts). 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	Social Support	Support from parents and friends, respectively, will be measured through the Procidano and Heller Perceived Social Support from Friends and 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