SuicideNCT05018143
Suicide Prevention Intervention for Vulnerable Emerging Adult Sexual Minorities
A study testing STARS in people with Suicide, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Suicide
- What is being tested?
- STARS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2022to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania, Center for the Treatment and Study of Anxiety
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Suicide
- Being tested
- STARS, Control condition
- Keywords
- Sexual minority, Suicide, Emerging adults
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STARSBehavioural
This intervention will use an online mobile application for teach life skills, coupled with peer mentoring to support the use of safety planning.
Control conditionBehavioural
In this intervention, participants will receive the safety planning intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: STARS |
| 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. Receives: Behavioral: Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 6 months
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start20 Oct 2022
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jose Bauermeister, University of Pennsylvania
- Investigators
- José A Bauermeister, PhD, MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018143
- Sponsor's protocol ID
- 849500
- Status last verified
- Jan 2025
- First submitted
- 11 Aug 2021
- Last updated
- 17 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset will be shared with the NIMH Data Archive.
Publications
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.
PubMed 41999074Tran 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.
PubMed 39879591Brown 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.
PubMed 37773618
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suicide Prevention Intervention for Vulnerable Emerging Adult Sexual Minorities
- ClinicalTrials.gov ID
- NCT05018143
- Acronym / sponsor ID
- 849500
- Conditions
- Suicide
- Keywords
- Sexual minority, Suicide, Emerging adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Posted 17 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| STARS | Experimental | Behavioral: STARSThe 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 | Behavioral: Control conditionThe 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STARSThis intervention will use an online mobile application for teach life skills, coupled with peer mentoring to support the use of safety planning. | Behavioural | STARS |
| Control conditionIn this intervention, participants will receive the safety planning intervention. | Behavioural | Control Condition |
Primary outcome
Suicidal Ideation and Behavior
Time frame: Change from baseline to 6 months
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.
3 secondary outcomes
Social Support
Time frame: Change from baseline to 6 months
Number of Participants Who Used Their Safety Plant at Least 1 Time
Time frame: Every 2 months until 6 months
Beck Scale for Suicide Ideation
Time frame: Change from baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41999074Brown 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.
- Derived from this study: PubMed 39879591Tran 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.
- Derived from this study: PubMed 37773618Brown 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.
- Individual participant dataSharing planned: Yes. The dataset will be shared with the NIMH Data Archive.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José A Bauermeister, PhD, MPH principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STARS in people with Suicide, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidal Ideation and Behavior (time frame: Change from baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05018143, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.