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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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)
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.

Dana M. Prince, PhD contact

216-368-1707

dana.prince@case.edu

United States1 site, 1 recruiting

  • Case Western Reserve University

    Cleveland, Ohio, 44106

    Dana Prince, PhD, 216-368-1707, dana.prince@case.edu

    Recruiting

Other trials in United States

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.

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 groups in NCT07214233
Study groupRoleWhat they receive
Pre-implementation PeriodActive comparatorBehavioral health treatment as usual
Receives: Behavioral: Treatment as Usual
Post-implementation PeriodExperimentalBehavioral 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.

  1. 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

  2. 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)

  1. 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

  2. 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

  3. 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.

  1. First posted9 Oct 2025
  2. Study start23 Feb 2026
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

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)
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 33942681

  • Gillani 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 38391800

  • Prince, 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

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.

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