Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05018143
Study type Interventional
Source University of Pennsylvania
Contact
Status Active, not recruiting
Phase N/A
Start date October 20, 2022
Completion date August 31, 2024

See also
  Status Clinical Trial Phase
Completed NCT04127292 - Impact of Clinician Virtual Human Interaction Training in Emotional Self-Awareness on Patients Suicidal Ideation and Suicide Crisis Syndrome N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Recruiting NCT05423483 - Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents Phase 2
Completed NCT03272048 - Identifying Effective Approaches to Counseling on Firearm Safety N/A
Completed NCT05514587 - Meaning of Life Questionnaire (MLQ) in Patients Admitted to the Crisis Centre (MSVCAC)
Enrolling by invitation NCT05639426 - Preventing Youth Violence Through Building Equitable Communities N/A
Completed NCT03703128 - Suicide in People Aged 45-60: A Case-control Psychological Autopsy Study
Completed NCT03646903 - Reducing Help-Seeking Stigma in Young Adults at Elevated Suicide Risk N/A
Not yet recruiting NCT05558332 - Youth Nominated Support Team N/A
Completed NCT02718248 - Ottawa Suicide Prevention in Men Pilot Study N/A
Completed NCT02094898 - Ketamine for Depression and Suicide Risk Phase 2
Completed NCT01360736 - A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL) N/A
Completed NCT01594138 - Linguistic Characteristics of Suicidal Patients in the Emergency Department N/A
Completed NCT02228044 - Alcohol, Suicide and HIV Prevention for Teens in Mental Health Treatment N/A
Completed NCT00604097 - Preventing Youth Suicide in Primary Care: A Family Model Phase 3
Completed NCT00387855 - An Evaluation of the SOS (Suicide Prevention) Program N/A
Recruiting NCT03519802 - Evaluation of Cognitive Function in a Suicidal Crisis
Completed NCT05580757 - Pharmacists as Gate Keepers in Suicide Prevention: Needs of Pharmacists
Recruiting NCT03030924 - Wearable Suicidal Early Warning System for Adolescents
Completed NCT03280225 - REACH VET Implementation Program Evaluation