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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STARS | Experimental | 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. |
|
| Control Condition | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STARS | Behavioral | This intervention will use an online mobile application for teach life skills, coupled with peer mentoring to support the use of safety planning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Social Support | Support from family respectively, will be measured through the Procidano and Heller Perceived Social Support 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José A Bauermeister, PhD, MPH | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania, Center for the Treatment and Study of Anxiety | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41999074 | Derived | Brown LA, Tran JT, Gallop R, Webster JL, Wolfe JR, Kautz MM, Zhu Y, Arcomano A, Nathan JB, Mayinja L, O'Connor AA, Mowery D, Mandell DS, Brown GK, Oquendo MA, Bauermeister JA. Increasing Safety Plan Use and Reducing Suicidal Ideation Among Emerging Adults: A Pilot Randomized Trial of the STARS Intervention. Suicide Life Threat Behav. 2026 Apr;56(2):e70101. doi: 10.1111/sltb.70101. | |
| 39879591 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| GUID | Individual Participant Data Set | View IPD |
The dataset will be shared with the NIMH Data Archive.
The investigators will upload initial data 6 months after the onset of data collection with regular additions approximately every 6 months.
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Participants complete the safety planning intervention prior to randomization.
Recruitment occurred through a targeted social media campaign.
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| ID | Title | Description |
|---|---|---|
| FG000 | STARS | 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. STARS: This intervention will use an online mobile application for teach life skills, coupled with peer mentoring to support the use of safety planning. |
| FG001 | Control Condition | 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. Control condition: In this intervention, participants will receive the safety planning intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Participants with past month suicidal ideation
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| ID | Title | Description |
|---|---|---|
| BG000 | STARS | 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. STARS: This intervention will use an online mobile application for teach life skills, coupled with peer mentoring to support the use of safety planning. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). 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. | Participants with past month suicidal ideation | Posted | Mean | Standard Deviation | Mean Units on the CSSRS SI scale | Change from baseline to 6 months |
|
6 months
N/A, Systematic assessment using the C-SSRS
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | STARS | 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. STARS: This intervention will use an online mobile application for teach life skills, coupled with peer mentoring to support the use of safety planning. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. José A. Bauermeister | University of Pennsylvania | 215-898-3242 | bjose@upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2024 | Dec 4, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 28, 2022 | Dec 4, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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.
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Outcomes evaluator will be blinded to randomization.
| Control condition | Behavioral | In this intervention, participants will receive the safety planning intervention. |
|
| Change from baseline to 6 months |
| Number of Participants Who Used Their Safety Plant at Least 1 Time | Self-reported use of their safety plan | Every 2 months until 6 months |
| Beck Scale for Suicide Ideation | Sum of self-reported suicide ideation, with a possible range from 0 - 38, with higher values reflecting greater severity of suicidal ideation. | Change from baseline to 6 months |
| Derived |
| Tran JT, Webster J, Wolfe JR, Ben Nathan J, Mayinja L, Kautz M, Oquendo MA, Brown GK, Mandell D, Mowery D, Bauermeister JA, Brown LA. Experiences of Peer Mentoring Sexual and Gender Minority Emerging Adults Who Are at Risk for Suicide: Mixed Methods Study. JMIR Form Res. 2025 Jan 29;9:e67814. doi: 10.2196/67814. |
| 37773618 | Derived | Brown LA, Webster JL, Tran JT, Wolfe JR, Golinkoff J, Patel E, Arcomano AC, Ben Nathan J, Azat O'Connor A, Zhu Y, Oquendo M, Brown GK, Mandell D, Mowery D, Bauermeister JA. A Suicide Prevention Intervention for Emerging Adult Sexual and Gender Minority Groups: Protocol for a Pilot Hybrid Effectiveness Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 29;12:e48177. doi: 10.2196/48177. |
| BG001 | Control Condition | 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. Control condition: In this intervention, participants will receive the safety planning intervention. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Mean |
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| Sex: Female, Male | One participant in the intervention arm identified as third-gender. Two participants did not report their sex assigned at birth. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Control Condition | 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. Control condition: In this intervention, participants will receive the safety planning intervention. |
|
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| Secondary | Social Support | Support from family respectively, will be measured through the Procidano and Heller Perceived Social Support 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. | Participants with past month suicidal ideation | Posted | Mean | Standard Deviation | Mean score on family support | Change from baseline to 6 months |
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| Secondary | Number of Participants Who Used Their Safety Plant at Least 1 Time | Self-reported use of their safety plan | Participants with past month suicidal ideation | Posted | Count of Participants | Participants | Every 2 months until 6 months |
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| Secondary | Beck Scale for Suicide Ideation | Sum of self-reported suicide ideation, with a possible range from 0 - 38, with higher values reflecting greater severity of suicidal ideation. | Participants with past month suicidal ideation | Posted | Mean | Standard Deviation | Score on the scale | Change from baseline to 6 months |
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| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Control Condition | 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. Control condition: In this intervention, participants will receive the safety planning intervention. | 0 | 32 | 0 | 32 | 0 | 32 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 2 months |
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| 4 months |
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| 6 months |
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| 4 months |
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| 6 months |
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| 2 months |
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| 4 months |
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| 6 months |
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