ClinicalTrials.Veeva

Menu

Efficacy of a Multi-level School Intervention for LGBTQ Youth

The Washington University logo

The Washington University

Status

Terminated

Conditions

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

Treatments

Behavioral: Proud & Empowered

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05541406
1R01MD016082-01A1 (U.S. NIH Grant/Contract)
202208172

Details and patient eligibility

About

Efficacy of a Multi-level School Intervention for LGBTQ Youth

Full description

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.

Enrollment

228 patients

Sex

All

Ages

12 to 20 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • LGBTQ student in one of 24 high schools

Exclusion criteria

  • Not meeting inclusion criteria

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

228 participants in 2 patient groups

Intervention schools
Experimental group
Description:
Schools will be assigned to either intervention or control schools. Students in intervention schools will receive the intervention in semester 1.
Treatment:
Behavioral: Proud & Empowered
Control schools
Active Comparator group
Description:
Students in control schools will receive no intervention
Treatment:
Behavioral: Proud & Empowered

Trial documents
2

Trial contacts and locations

21

Loading...

Central trial contact

John G Senese IV, MSW

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems