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NCT Number: NCT07214233

Youth Empowerment and Safety Intervention

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.

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Self-Injurious Behavior

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Location contact

Dana Prince, PhD

CONTACT

[email protected]

216-368-1707

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment as Usual

Behavioral

Behavioral health services (treatment as usual)

Peer Support Services (PSS)

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Patient Health Questionnaire - Depression Scale - PHQ-9

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

    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.

  2. Youth level changes in minority stress

    Time frame: baseline, 3- month post, 6-month follow up

    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.

  3. Youth Level Changes in Perceived Parent Acceptance

    Time frame: baseline, 3-month post, 6 month follow up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dana M. Prince, PhD

CONTACT

[email protected]

216-368-1707

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • FrontLine Service
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Youth Empowerment and Safety Intervention for Systems-involved Sexual and Gender Minority Youth at Risk of Suicide

Acronym: YES

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 9, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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