NCT07214233

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Feb 2026Nov 2027

First Submitted

Initial submission to the registry

October 7, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

February 23, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1.8 years

First QC Date

October 7, 2025

Last Update Submit

May 6, 2026

Conditions

SuicideSelf-Injurious Behavior

Keywords

Self-injurious thoughts and behaviors (SITB)Peer Support Specialist (PSS)Behavioral healthadolescentLGBTQJuvenile JusticeFoster CareCrisis Response

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    Study enrollment (baseline) and 3- and 6-month follow-ups

  • Youth level changes in minority stress

    baseline, 3- month post, 6-month follow up

  • Youth Level Changes in Perceived Parent Acceptance

    baseline, 3-month post, 6 month follow up

Study Arms (2)

Pre-implementation Period

ACTIVE COMPARATOR

Behavioral health treatment as usual

Behavioral: Treatment as Usual

Post-implementation Period

EXPERIMENTAL

Behavioral health treatment as usual + referral to and connection with Peer Support Services

Behavioral: Peer Support Services (PSS)

Interventions

Treatment as UsualBEHAVIORAL

Behavioral health services (treatment as usual)

Pre-implementation Period
Peer Support Services (PSS)BEHAVIORAL

Behavioral health services (treatment as usual) along with referral to and utilization of Peer Support Specialist services

Post-implementation Period

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • years of age
  • English speaking
  • Willing and able to provide informed consent
  • Less than 18 or greater than 80 years of age (0-17 or 81 and over)
  • Not English speaking
  • Unwilling and/or unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 33942681BACKGROUND

  • 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.

    PMID: 38391800BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 41367936BACKGROUND

MeSH Terms

Conditions

SuicideSelf-Injurious BehaviorBehavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms

Study Officials

  • Dana M. Prince, PhD

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana M. Prince, PhD

CONTACT

216-368-1707dana.prince@case.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2025

First Posted

October 9, 2025

Study Start

February 23, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

May 8, 2026

Record last verified: 2026-05

Locations

US(1)