Efficacy of a Multi-level School Intervention for LGBTQ Youth

NCT05541406 | Terminated DMC

• 2 other identifiers: 2022081721R01MD016082-01A1
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 21

Brief Summary

Efficacy of a Multi-level School Intervention for LGBTQ Youth

Conditions

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

Keywords

LGBTQ+ Youth; LGBT Youth; Queer Youth

Outcome Measures

Primary Outcomes (6)

• Sexual Minority Stress Inventory

  54-item survey across 10 domains of minority stress. Assesses experiences of minority stress among adolescents. Each statement reflects past-30-day thoughts, feelings, and situations a person may have experienced, with response options of 1 = yes and 0 = no. A total score was calculated by summing the 54 items. The total score ranged from 0-54. Higher values correspond to a worse outcome, meaning the individual in question has had more stressful experiences.

  Change between baseline and post-intervention/follow-up (12 weeks)

• Beck Anxiety Inventory (BAI)

  21-item self-report assessment of anxiety symptoms. The total score is calculated by taking the sum of the 21 items. There are five responses an individual can choose from for each item, these being "Not at all" which is scored as a 1, "Mildly, but it didn't bother me much" which is scored as a 2, "Moderately -- It wasn't pleasant at times" which is scored as a 3, "Severely -- It bothered me a lot" which is scored as a 4, and "Decline to answer" which is scored as a 5. The total score ranges from 0-63. Higher values indicate higher self-reported anxiety: Score of 0-21 indicates low anxiety, Score of 22-35 indicates moderate anxiety, Scores of 36+ indicates potentially concerning levels of anxiety. Subscales are calculated through summation.

  Change between baseline and post-intervention/follow-up (12 weeks)

• PTSD Checklist for DSM-5 (PCL-5)

  20-item self-report assessment of post-traumatic stress disorder (PTSD) symptoms which addresses all 20 DSM-5 symptoms of PTSD. A total symptom severity score can be calculated by summing the scores for each of the 20 items. Each item has five possible responses including "Not at all" which is scored as a 0, "A little bit" which is scored as a 1, "Moderately" which is scored as 2, "Quite a bit" which is scored as a 3, and "Extremely" which is scored as a 4. The potential range of scores is 0-80. Higher scores indicate a worse outcome where the individual has higher severity of PTSD symptoms.

  Change between baseline and post-intervention/follow-up (12 weeks)

• Beck Depression Inventory

  21-item self-report assessment of depression symptoms and severity of depression. The items are rated on a 4-point scale ranging from 0-3 based on the severity of each item (e.g., 0=I do not feel sad, 1=I feel sad much of the time, 2=I am sad all the time, and 3=I am so sad or unhappy that I can't stand it). The total range of scores is from 0-63. Higher values indicate a worse outcome and indicates a greater severity of depression. Scores of 0-13 indicates minimal depression, scores of 14-19 indicates mild depression, scores of 20-28 indicates moderate depression, scores of 29-63 indicates severe depression. Subscale values are achieved through summation.

  Change between baseline and post-intervention/follow-up (12 weeks)

• Coping Strategies Inventory

  16-item assessment measuring specific coping strategies people use in response to stressful events. Individuals respond to 16 items, with each item assessing components of Problem Solving, Cognitive Restructuring, Social Support, Express Emotions, Problem Avoidance, Wishful Thinking, and Social Withdrawal. Individuals can respond in 5 different ways, these being "Never", "Seldom", "Sometimes", "Often", or "Almost Always". These responses are scored from 1-5 with "Never" being a 1 and "Almost Always" being a 5. The total score is a summation of item scores with a range from 16-80. Higher scores in a particular primary scale indicates that the individual implements that form of coping strategy more often.

  Change between baseline and post-intervention/follow-up (12 weeks)

• Adapted CSSRS Suicide Questions (Columbia Suicide Severity Rating Scale)

  Six items assessing current suicidality that were adapted from the longer, treatment-based Columbia Suicide Severity Rating Scale. The first two items ask about passive ideation and active ideation, and affirmative responses link to follow-up questions about methods, intent, plans, and attempts. The scale is scored as follows: 0 = no to passive ideation and no to active ideation; 1 = yes to passive ideation (but no to active ideation); 2 = yes to active ideation (but no method, intent, plan); 3 = yes to method (but no intent or plan); 4 = yes to intent (but no plan); 5 = yes to plan; Attempts can be scored on its own or added to the overall scale for a risk score of 6 if participant has a recent suicide attempt.

  Change between baseline and post-intervention/follow-up (12 weeks)

Secondary Outcomes (2)

• Youth Risk Behavior Survey Substance Use Questions

  Change between baseline and post-intervention/follow-up (12 weeks)

• California Healthy Kids Survey General Bullying and Gender Identity/Sexual Orientation-Based Harassment Module

  Change between baseline and post-intervention/follow-up (12 weeks)

Study Arms (2)

Intervention schools

EXPERIMENTAL

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

Behavioral: Proud & Empowered

Control schools

ACTIVE COMPARATOR

Students in control schools will receive no intervention

Behavioral: Proud & Empowered

Interventions

Proud & Empowered 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; Intervention schools

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• LGBTQ student in one of 24 high schools

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• University of Southern California: collaborator

Study Sites (21)

El Monte High School

El Monte, California, 91731, United States

Location

Arroyo High School

El Monte, California, 91732, United States

Location

Fernando R Ledesma High School

El Monte, California, 91732, United States

Location

Mountain View High School

El Monte, California, 91732, United States

Location

South El Monte High School

El Monte, California, 91733, United States

Location

Anderson W. Clark Magnet High School

Glendale, California, 91214, United States

Location

Animo Leadership High School

Inglewood, California, 90304, United States

Location

Crescenta Valley High School

La Crescenta-Montrose, California, 91214, United States

Location

Millikan High School

Long Beach, California, 90815, United States

Location

Animo Pat Brown Charter High School

Los Angeles, California, 90001, United States

Location

USC Hybrid High School

Los Angeles, California, 90037, United States

Location

South LA College Prep

Los Angeles, California, 90044, United States

Location

Larchmont Charter School

Los Angeles, California, 90057, United States

Location

Brio College Prep

Los Angeles, California, 90071, United States

Location

Lynwood High School

Lynwood, California, 90262, United States

Location

Marco Antonio Firebaugh High School

Lynwood, California, 90262, United States

Location

Vista High School

Lynwood, California, 90262, United States

Location

Marshall Fundamental Secondary School

Pasadena, California, 91104, United States

Location

Blair High School

Pasadena, California, 91106, United States

Location

Pasadena High School

Pasadena, California, 91107, United States

Location

Rosemead High School

Rosemead, California, 91770, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic; Suicidal Ideation; Substance-Related Disorders; Bullying

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Suicide; Self-Injurious Behavior; Chemically-Induced Disorders; Aggression; Harassment, Non-Sexual; Social Behavior

Study Officials

• Jeremy Goldbach, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters & Johnson Distinguished Professor of Sexual Health and Education

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 15, 2022
• Study Start: September 14, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)