Suicide Prevention Intervention for Vulnerable Emerging Adult Sexual Minorities
Primary Purpose
Suicide
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STARS
Control condition
Sponsored by
About this trial
This is an interventional treatment trial for Suicide focused on measuring Sexual minority, Suicide, Emerging adults
Eligibility Criteria
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
Sites / Locations
- University of Pennsylvania, Center for the Treatment and Study of AnxietyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
STARS
Control Condition
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05018143
First Posted
August 11, 2021
Last Updated
May 9, 2023
Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05018143
Brief Title
Suicide Prevention Intervention for Vulnerable Emerging Adult Sexual Minorities
Official Title
Suicide Prevention Intervention for Vulnerable Emerging Adult Sexual Minorities
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Sexual minority, Suicide, Emerging adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Outcomes evaluator will be blinded to randomization.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
STARS
Arm Type
Experimental
Arm 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.
Arm Title
Control Condition
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
STARS
Intervention Description
This intervention will use an online mobile application for teach life skills, coupled with peer mentoring to support the use of safety planning.
Intervention Type
Behavioral
Intervention Name(s)
Control condition
Intervention Description
In this intervention, participants will receive the safety planning intervention.
Primary Outcome Measure Information:
Title
Suicidal Ideation and Behavior
Description
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.
Time Frame
Change from baseline to 6 months
Secondary Outcome Measure Information:
Title
Social Support
Description
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.
Time Frame
Change from baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Wolfe, MS
Phone
215-746-5869
Email
jameswol@nursing.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lily A Brown, PhD
Phone
215-746-3346
Email
lilybr@upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José A Bauermeister, PhD, MPH
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania, Center for the Treatment and Study of Anxiety
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Wolf, MS
Phone
215-746-5869
Email
jameswol@nursing.upenn.edu
First Name & Middle Initial & Last Name & Degree
Lily Brown, PhD
Phone
2157463346
Email
lilybr@upenn.edu
First Name & Middle Initial & Last Name & Degree
José A Bauermeister, PhD
First Name & Middle Initial & Last Name & Degree
Lily A Brown, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The dataset will be shared with the NIMH Data Archive.
IPD Sharing Time Frame
The investigators will upload initial data 6 months after the onset of data collection with regular additions approximately every 6 months.
IPD Sharing URL
https://nda.nih.gov/
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://nda.nih.gov/
Available IPD/Information Identifier
GUID
Learn more about this trial
Suicide Prevention Intervention for Vulnerable Emerging Adult Sexual Minorities
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