SuicideYESNCT07214233
Youth Empowerment and Safety Intervention
A study testing Treatment as Usual and Peer Support Services (PSS) in people with Suicide and Self-Injurious Behavior, run by Case Western Reserve University at 1 site in United States.
Trial summary
This clinical trial will implement and evaluate the feasibility, acceptability, and initial impact of Peer Support Specialist (PSS) services for public system-involved sexual and gender minority (lesbian, gay, bisexual, queer and/or transgender) youth (SGMY) at risk of suicide. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Suicide, Self-Injurious Behavior
- What is being tested?
- Treatment as Usual and Peer Support Services (PSS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Child Inclusion Criteria:
- 12-17 years of age
- Self-identify as a sexual or gender minority (SGM)
- Involved in one or more system: juvenile justice, child welfare, and/or community-based mental health
- Personal experience with self-injurious thoughts and behaviors (SITB)
- English speaking
- Willing and able to provide informed assent
Child Exclusion Criteria:
- Less than 12 or greater than 17 years of age (0-11 or 18 and over)
- Do not self-identify as a sexual or gender minority (SGM)
- Not involved in the juvenile justice, child welfare, and/or community-based mental health systems
- No personal experience with self-injurious thoughts and behaviors (SITB)
- Not English speaking
- Unwilling and/or unable to provide informed assent
Caregiver Inclusion Criteria:
- 18-80 years of age
- Primary Caregiver of youth who meet child inclusion criteria listed above
- English speaking
- Willing and able to provide informed consent
Caregiver Exclusion Criteria:
- Less than 18 or greater than 80 years of age (0-17 or 81 and over)
- Not the Primary Caregiver of youth who meet child inclusion criteria listed above
- Not English speaking
- Unwilling and/or unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Dana Prince, PhD, 216-368-1707, dana.prince@case.edu
About this study
Official title: Youth Empowerment and Safety Intervention for Systems-involved Sexual and Gender Minority Youth at Risk of Suicide
This clinical trial will implement and evaluate the feasibility, acceptability, and initial impact of Peer Support Specialist (PSS) services for public system-involved sexual and gender minority (lesbian, gay, bisexual, queer and/or transgender) youth (SGMY) at risk of suicide.
Read the detailed description
A sharp increase in U.S. youth mental health problems coupled with the national shortage in child behavioral health clinicians has identified peer providers as a cost- and impact-effective solution. Peer Support Specialists (PSS), paraprofessionals with lived experience who provide mutual and structured support, have been found to be effective in improving client engagement in mental health services. The study proposes to evaluate the feasibility, acceptability, and initial impact of a multi-level intervention, Youth Empowerment \& Safety (YES), comprised of two coordinated components: 1) system-level improved identification and referral (I/R) of self-injurious thoughts and behaviors (SITB) among sexual and gender minority youth (SGMY), and 2) introduction of an SGMY-tailored support PSS to enhance engagement and support with behavioral health treatment and other support services.
- Conditions
- Suicide, Self-Injurious Behavior
- Being tested
- Treatment as Usual, Peer Support Services (PSS)
- Keywords
- Self-injurious thoughts and behaviors (SITB), Peer Support Specialist (PSS), Behavioral health, adolescent, LGBTQ, Juvenile Justice, Foster Care, Crisis Response
- Medical subject headings
- Suicide, Self-Injurious Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as UsualBehavioural
Behavioral health services (treatment as usual)
Peer Support Services (PSS)Behavioural
Behavioral health services (treatment as usual) along with referral to and utilization of Peer Support Specialist services
| Study group | Role | What they receive |
|---|---|---|
| Pre-implementation Period | Active comparator | Behavioral health treatment as usual Receives: Behavioral: Treatment as Usual |
| Post-implementation Period | Experimental | Behavioral health treatment as usual + referral to and connection with Peer Support Services Receives: Behavioral: Peer Support Services (PSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Youth-level changes in Recovery
The researchers will compare the change in treatment engagement as quantified by total score on two separate subscales of the Questionnaire about the Process of Recovery (the QPR). The QPR is a 22-item measure developed from service users' accounts of recovery in collaboration with local service users. Each item is scored using a 5-point Likert scale ranging from 0 (disagree strongly) to 4 (agree strongly). There are two subscales: 1) intrapersonal tasks involved in recovery (17 items, range 0-68) and 2) interpersonal factors that facilitate recovery (5 items, range 0-20) with higher scores indicating increased recovery on both subscales.
Measured: Baseline, Post-Intervention 3 Month, and Post Intervention 6 Month
Youth Level Changes in Self-injurious thoughts and behaviors
The researchers will compare changes in suicidal ideation, planning, attempt and non-suicidal self-harm in a group of pre-intervention (nonrandomized) youth to post-intervention (nonrandomized youth) using the Columbia Suicide Severity Rating Scale (C-SSRS), a widely used and well-validated measure of suicidal ideation, planning, attempt, and non-suicidal self-harm.
Measured: From enrollment (baseline), to 3- and 6 months follow ups post treatment at the end of 8-12 weeks.
Secondary outcomes (3)
Patient Health Questionnaire - Depression Scale - PHQ-9
The Patient Health Questionnaire - Depression Scale (PHQ-9) is a validated measure of depression consisting of nine questions that assess the severity of depressive symptoms over the past two weeks. Each item is scored using a 4-point Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). The scale provides a cumulative score (range from 0-27) with higher scores suggesting more severe depressive symptoms.
Measured: Study enrollment (baseline) and 3- and 6-month follow-ups
Youth level changes in minority stress
The researchers will assess changes in minority stress, as measured by the Adolescent Minority Stress Inventory. This is a 26-item measure of minority stressors experienced by LGBTQ+ youth in the past 30 days utilizing a binary Yes/No scale (yes = 1, no = 0). The scale provides a cumulative score (range from 0-30) with higher scores suggesting higher stress.
Measured: baseline, 3- month post, 6-month follow up
Youth Level Changes in Perceived Parent Acceptance
The Family Acceptance Measure is a 6-item measure of youths' perception of accepting and rejecting attitudes and behaviors of LGBTQ+ youth. Each item is scored using a 4-point Likert scale ranging from 0 (Never) to 3 (Often). The scale provides a cumulative score (range from 0-18) with higher scores suggesting less familial acceptance.
Measured: baseline, 3-month post, 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start23 Feb 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- FrontLine Service, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Dana M. Prince, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214233
- Sponsor's protocol ID
- STUDY20241289
- Other IDs
- 1R34MH134912-01A1
- Acronym
- YES
- Status last verified
- May 2026
- First submitted
- 7 Oct 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a community participatory research design. Members of the Learning Collaborative will be involved in the final decision about IPD sharing.
Publications
Prince DM, Ray-Novak M, Gillani B, Peterson E. Sexual and Gender Minority Youth in Foster Care: An Evidence-Based Theoretical Conceptual Model of Disproportionality and Psychological Comorbidities. Trauma Violence Abuse. 2022 Dec;23(5):1643-1657. doi: 10.1177/15248380211013129. Epub 2021 May 4.
PubMed 33942681Gillani B, Prince DM, Ray-Novak M, Feerasta G, Jones D, Mintz LJ, Moore SE. Mapping the Dynamic Complexity of Sexual and Gender Minority Healthcare Disparities: A Systems Thinking Approach. Healthcare (Basel). 2024 Feb 6;12(4):424. doi: 10.3390/healthcare12040424.
PubMed 38391800Prince, D. M., Ray-Novak, M*. Tossone, K., Peterson, E.*, Gillani, B.*, & Mintz, L. (2024). Psychological comorbidities and suicidality in sexual and gender minority foster youth. Children and Youth Services Review, 156 (2024): 107379.
Prince DM, Schuler MS, Lewis K, Munson MR, Blashill AJ, Hovmand PS. Opportunities to Address Health Disparities in Suicidality for Sexual and Gender Minority Youth in Public Systems. Mental Health Sci. 2025 Mar;3(1):10.1002/mhs2.100. doi: 10.1002/mhs2.100. Epub 2024 Dec 19. No abstract available.
PubMed 41367936
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth Empowerment and Safety Intervention for Systems-involved Sexual and Gender Minority Youth at Risk of Suicide
- ClinicalTrials.gov ID
- NCT07214233
- Acronym / sponsor ID
- YES / STUDY20241289
- Conditions
- Suicide, Self-Injurious Behavior
- Keywords
- Self-injurious thoughts and behaviors (SITB), Peer Support Specialist (PSS), Behavioral health, adolescent, LGBTQ, Juvenile Justice, Foster Care, Crisis Response
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- FrontLine Service, National Institute of Mental Health (NIMH)
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial will implement and evaluate the feasibility, acceptability, and initial impact of Peer Support Specialist (PSS) services for public system-involved sexual and gender minority (lesbian, gay, bisexual, queer and/or transgender) youth (SGMY) at risk of suicide.
Detailed description
A sharp increase in U.S. youth mental health problems coupled with the national shortage in child behavioral health clinicians has identified peer providers as a cost- and impact-effective solution. Peer Support Specialists (PSS), paraprofessionals with lived experience who provide mutual and structured support, have been found to be effective in improving client engagement in mental health services. The study proposes to evaluate the feasibility, acceptability, and initial impact of a multi-level intervention, Youth Empowerment \& Safety (YES), comprised of two coordinated components: 1) system-level improved identification and referral (I/R) of self-injurious thoughts and behaviors (SITB) among sexual and gender minority youth (SGMY), and 2) introduction of an SGMY-tailored support PSS to enhance engagement and support with behavioral health treatment and other support services.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation Period | Active comparator | Behavioral: Treatment as UsualBehavioral health treatment as usual |
| Post-implementation Period | Experimental | Behavioral: Peer Support Services (PSS)Behavioral health treatment as usual + referral to and connection with Peer Support Services |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Treatment as UsualBehavioral health services (treatment as usual) | Behavioural | Pre-implementation Period |
| Peer Support Services (PSS)Behavioral health services (treatment as usual) along with referral to and utilization of Peer Support Specialist services | Behavioural | Post-implementation Period |
Primary outcome
Youth-level changes in Recovery
Time frame: Baseline, Post-Intervention 3 Month, and Post Intervention 6 Month
The researchers will compare the change in treatment engagement as quantified by total score on two separate subscales of the Questionnaire about the Process of Recovery (the QPR). The QPR is a 22-item measure developed from service users' accounts of recovery in collaboration with local service users. Each item is scored using a 5-point Likert scale ranging from 0 (disagree strongly) to 4 (agree strongly). There are two subscales: 1) intrapersonal tasks involved in recovery (17 items, range 0-68) and 2) interpersonal factors that facilitate recovery (5 items, range 0-20) with higher scores indicating increased recovery on both subscales.
Youth Level Changes in Self-injurious thoughts and behaviors
Time frame: From enrollment (baseline), to 3- and 6 months follow ups post treatment at the end of 8-12 weeks.
The researchers will compare changes in suicidal ideation, planning, attempt and non-suicidal self-harm in a group of pre-intervention (nonrandomized) youth to post-intervention (nonrandomized youth) using the Columbia Suicide Severity Rating Scale (C-SSRS), a widely used and well-validated measure of suicidal ideation, planning, attempt, and non-suicidal self-harm.
3 secondary outcomes
Patient Health Questionnaire - Depression Scale - PHQ-9
Time frame: Study enrollment (baseline) and 3- and 6-month follow-ups
Youth level changes in minority stress
Time frame: baseline, 3- month post, 6-month follow up
Youth Level Changes in Perceived Parent Acceptance
Time frame: baseline, 3-month post, 6 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 33942681Prince DM, Ray-Novak M, Gillani B, Peterson E. Sexual and Gender Minority Youth in Foster Care: An Evidence-Based Theoretical Conceptual Model of Disproportionality and Psychological Comorbidities. Trauma Violence Abuse. 2022 Dec;23(5):1643-1657. doi: 10.1177/15248380211013129. Epub 2021 May 4.
- Background: PubMed 38391800Gillani B, Prince DM, Ray-Novak M, Feerasta G, Jones D, Mintz LJ, Moore SE. Mapping the Dynamic Complexity of Sexual and Gender Minority Healthcare Disparities: A Systems Thinking Approach. Healthcare (Basel). 2024 Feb 6;12(4):424. doi: 10.3390/healthcare12040424.
- BackgroundPrince, D. M., Ray-Novak, M*. Tossone, K., Peterson, E.*, Gillani, B.*, & Mintz, L. (2024). Psychological comorbidities and suicidality in sexual and gender minority foster youth. Children and Youth Services Review, 156 (2024): 107379.
- Background: PubMed 41367936Prince DM, Schuler MS, Lewis K, Munson MR, Blashill AJ, Hovmand PS. Opportunities to Address Health Disparities in Suicidality for Sexual and Gender Minority Youth in Public Systems. Mental Health Sci. 2025 Mar;3(1):10.1002/mhs2.100. doi: 10.1002/mhs2.100. Epub 2024 Dec 19. No abstract available.
- Individual participant dataSharing planned: Undecided. This is a community participatory research design. Members of the Learning Collaborative will be involved in the final decision about IPD sharing.
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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.
Dana M. Prince, PhD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as Usual and Peer Support Services (PSS) in people with Suicide and Self-Injurious Behavior, run by Case Western Reserve University 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?
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: looking for participants now, as of the sponsor's last update on 8 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dana M. Prince, PhD (216-368-1707, dana.prince@case.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Youth-level changes in Recovery (time frame: Baseline, Post-Intervention 3 Month, and Post Intervention 6 Month). The study lists 2 primary outcomes in all. 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 NCT07214233, which also lists 4 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 8 May 2026.