Feasibility of a Multi-Level School Intervention for LGBTQ Youth

NCT ID: NCT04041414

Last Updated: 2021-07-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-04

Study Completion Date

2020-04-30

Brief Summary

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The goal of this R21 grant is to test the feasibility of a theoretically informed, LGBTQ-affirming intervention (Proud \& Empowered; P\&E). Although LGBTQ adolescents experience disparities in behavioral health outcomes compared to their heterosexual peers, interventions are scarce. For example, LGBTQ adolescents are 3 to 4 times more likely to meet criteria for an internalizing disorder and 2 to 5 times more likely to meet criteria for externalizing disorders than their heterosexual peers. Our intervention seeks to address disparate behavioral health problems such as depression, anxiety and trauma symptomology. Our goal will be achieved by completing two specific aims: 1) Assess the feasibility, including recruitment, enrollment, fidelity of service delivery, satisfaction, safety, and retention, of the intervention in a randomized control trial with four schools, 2) Obtain preliminary estimates of intervention effects on key behavioral health symptoms for LGBTQ youth and school climate (norms, attitudes, beliefs, behaviors) at the school level in preparation for a larger efficacy trial. This innovative R21 application brings together a team of nationally recognized minority stress and prevention science experts and responds to a nationally established public health need for research from the Institute of Medicine, the National Institutes of Health, and the National Gay and Lesbian Task Force.

Detailed Description

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Conditions

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Sexual Minority Stress Experiences Among LGBTQ Youth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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 OTHER

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 OTHER

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 OTHER

Eligibility Criteria

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Inclusion Criteria

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

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Jeremy Goldbach

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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John Muir High School

Pasadena, California, United States

Site Status

Marshall Fundamental High 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

Countries

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United States

References

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Goldbach JT, Rhoades H, Mamey MR, Senese J, Karys P, Marsiglia FF. Reducing behavioral health symptoms by addressing minority stressors in LGBTQ adolescents: a randomized controlled trial of Proud & Empowered. BMC Public Health. 2021 Dec 23;21(1):2315. doi: 10.1186/s12889-021-12357-5.

Reference Type DERIVED
PMID: 34949171 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

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Other Identifiers

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1R21MD013971

Identifier Type: NIH

Identifier Source: org_study_id

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