Clinical trial NCT05541406: Efficacy of a Multi-level School Intervention for LGBTQ Youth
Official title: Efficacy of a Multi-level School Intervention for LGBTQ Youth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Post Traumatic Stress Disorder
Coping Behavior
Sexual Minority Stress
Suicidality
Substance Use
Bullying
Harassment
Keywords: LGBTQ+ Youth
LGBT Youth
Queer Youth
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: University of Southern California
First posted: 2022-09-15
Enrollment: 450
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Efficacy of a Multi-level School Intervention for LGBTQ Youth

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* LGBTQ student in one of 24 high schools

Exclusion Criteria:

* Not meeting inclusion criteria

Primary outcomes:
measure: Sexual Minority Stress Inventory
timeFrame: Change between baseline and post-intervention/follow-up (12 weeks)
measure: Beck Anxiety Inventory (BAI)
timeFrame: Change between baseline and post-intervention/follow-up (12 weeks)
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Change between baseline and post-intervention/follow-up (12 weeks)
measure: Beck Depression Inventory
timeFrame: Change between baseline and post-intervention/follow-up (12 weeks)
measure: Coping Strategies Inventory
timeFrame: Change between baseline and post-intervention/follow-up (12 weeks)
measure: Adapted CSSRS Suicide Questions (Columbia Suicide Severity Rating Scale)
timeFrame: Change between baseline and post-intervention/follow-up (12 weeks)
Secondary outcomes:
measure: Youth Risk Behavior Survey Substance Use Questions
timeFrame: Change between baseline and post-intervention/follow-up (12 weeks)
measure: California Healthy Kids Survey General Bullying and Gender Identity/Sexual Orientation-Based Harassment Module
timeFrame: Change between baseline and post-intervention/follow-up (12 weeks)
Other outcomes:
Locations:
city: El Monte
country: United States
facility: El Monte High School
state: California
city: El Monte
country: United States
facility: Arroyo High School
state: California
city: El Monte
country: United States
facility: Fernando R Ledesma High School
state: California
city: El Monte
country: United States
facility: Mountain View High School
state: California
city: El Monte
country: United States
facility: South El Monte High School
state: California
city: Glendale
country: United States
facility: Anderson W. Clark Magnet High School
state: California
city: Inglewood
country: United States
facility: Animo Leadership High School
state: California
city: La Crescenta-Montrose
country: United States
facility: Crescenta Valley High School
state: California
city: Long Beach
country: United States
facility: Millikan High School
state: California
city: Los Angeles
country: United States
facility: Animo Pat Brown Charter High School
state: California
city: Los Angeles
country: United States
facility: USC Hybrid High School
state: California
city: Los Angeles
country: United States
facility: South LA College Prep
state: California
city: Los Angeles
country: United States
facility: Larchmont Charter School
state: California
city: Los Angeles
country: United States
facility: Brio College Prep
state: California
city: Lynwood
country: United States
facility: Lynwood High School
state: California
city: Lynwood
country: United States
facility: Marco Antonio Firebaugh High School
state: California
city: Lynwood
country: United States
facility: Vista High School
state: California
city: Pasadena
country: United States
facility: Marshall Fundamental Secondary School
state: California
city: Pasadena
country: United States
facility: Blair High School
state: California
city: Pasadena
country: United States
facility: Pasadena High School
state: California
city: Rosemead
country: United States
facility: Rosemead High School
state: California
Study officials:
affiliation: Washington University School of Medicine
name: Jeremy Goldbach, PhD
role: PRINCIPAL_INVESTIGATOR
References: