Efficacy of a Multi-level School Intervention for LGBTQ Youth

NCT ID: NCT05541406

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-14

Study Completion Date

2025-07-01

Brief Summary

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Efficacy of a Multi-level School Intervention for LGBTQ Youth

Detailed Description

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The goal of this R01 grant is to test the efficacy of a theoretically informed, LGBTQ-affirming intervention (Proud \& Empowered; P\&E) alongside a school climate intervention (Make Space).

Sexual and gender minority adolescents (SGMA) experience victimization in schools at much higher rates than their peers, and although SGMA experience disparities in behavioral health outcomes compared to their heterosexual peers, interventions are scarce.

The investigators P\&E intervention aims to allow youth participants to discuss their experiences of bullying and victimization, to build coping skills and to plan stress management strategies, while the investigators Make Space intervention is an indirect, environmental strategy aimed at improving overall school climate. The investigators goal will be achieved by completing three specific aims: 1) Determine participant-level efficacy of the intervention in an RCT with 24 schools (6-10 schools each year over 4 years); 2) Determine the school-wide intervention effects on (a) reporting of minority stress and behavioral health outcomes among all SGMA students and (b) perceptions of school climate (norms, attitudes, beliefs, bullying behaviors toward SGM youth, policies) among all students, and; 3) Examine factors that may affect intervention success (e.g., fidelity of implementation, barriers or facilitators to implementation, school or student characteristics) to prepare the intervention for future dissemination. This intervention has been tested in a previous, smaller, Feasibility study with 4 high schools.

Conditions

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Depression Anxiety Post Traumatic Stress Disorder Coping Behavior Sexual Minority Stress Suicidality Substance Use Bullying Harassment

Keywords

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LGBTQ+ Youth LGBT Youth Queer Youth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention schools

Schools will be assigned to either intervention or control schools. Students in intervention schools will receive the intervention in semester 1.

Group Type EXPERIMENTAL

Proud & Empowered

Intervention Type BEHAVIORAL

Proud \& Empowered! is a school-based intervention to decrease sexual minority stress and improve coping among LGBTQ students. It is administered by school counselors and trained social workers.

Control schools

Students in control schools will receive no intervention

Group Type ACTIVE_COMPARATOR

Proud & Empowered

Intervention Type BEHAVIORAL

Proud \& Empowered! is a school-based intervention to decrease sexual minority stress and improve coping among LGBTQ students. It is administered by school counselors and trained social workers.

Interventions

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Proud & Empowered

Proud \& Empowered! is a school-based intervention to decrease sexual minority stress and improve coping among LGBTQ students. It is administered by school counselors and trained social workers.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* LGBTQ student in one of 24 high schools
Minimum Eligible Age

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jeremy T. Goldbach

Masters & Johnson Distinguished Professor of Sexual Health and Education

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeremy Goldbach, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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El Monte High School

El Monte, California, United States

Site Status

Arroyo High School

El Monte, California, United States

Site Status

Fernando R Ledesma High School

El Monte, California, United States

Site Status

Mountain View High School

El Monte, California, United States

Site Status

South El Monte High School

El Monte, California, United States

Site Status

Anderson W. Clark Magnet High School

Glendale, California, United States

Site Status

Animo Leadership High School

Inglewood, California, United States

Site Status

Crescenta Valley High School

La Crescenta-Montrose, California, United States

Site Status

Millikan High School

Long Beach, California, United States

Site Status

Animo Pat Brown Charter High School

Los Angeles, California, United States

Site Status

USC Hybrid High School

Los Angeles, California, United States

Site Status

South LA College Prep

Los Angeles, California, United States

Site Status

Larchmont Charter School

Los Angeles, California, United States

Site Status

Brio College Prep

Los Angeles, California, United States

Site Status

Lynwood High School

Lynwood, California, United States

Site Status

Marco Antonio Firebaugh High School

Lynwood, California, United States

Site Status

Vista High School

Lynwood, California, United States

Site Status

Marshall Fundamental Secondary School

Pasadena, California, United States

Site Status

Blair High School

Pasadena, California, United States

Site Status

Pasadena High School

Pasadena, California, United States

Site Status

Rosemead High School

Rosemead, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R01MD016082-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202208172

Identifier Type: -

Identifier Source: org_study_id