Efficacy of a Multi-level School Intervention for LGBTQ Youth
2 other identifiers
interventional
228
1 country
23
Brief Summary
Efficacy of a Multi-level School Intervention for LGBTQ Youth
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Sep 2022
Longer than P75 for not_applicable depression
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2022
CompletedStudy Start
First participant enrolled
September 14, 2022
CompletedFirst Posted
Study publicly available on registry
September 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
September 11, 2026
September 1, 2026
4.6 years
September 12, 2022
September 8, 2026
Conditions
Keywords
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
EXPERIMENTALSchools will be assigned to either intervention or control schools. Students in intervention schools will receive the intervention in semester 1.
Control schools
ACTIVE COMPARATORStudents in control schools will receive no intervention
Interventions
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.
Schools in this condition will not receive the Proud \& Empowered intervention. Students in this condition will provide data spaced to align with the timing of the intervention delivered to schools in the other study arm.
Eligibility Criteria
You may qualify if:
- LGBTQ student in one of 24 high schools
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
El Monte High School
El Monte, California, 91731, United States
Arroyo High School
El Monte, California, 91732, United States
Fernando R Ledesma High School
El Monte, California, 91732, United States
Mountain View High School
El Monte, California, 91732, United States
South El Monte High School
El Monte, California, 91733, United States
Anderson W. Clark Magnet High School
Glendale, California, 91214, United States
Inglewood High School
Inglewood, California, 90303, United States
Animo Leadership High School
Inglewood, California, 90304, United States
Crescenta Valley High School
La Crescenta-Montrose, California, 91214, United States
Millikan High School
Long Beach, California, 90815, United States
Animo Pat Brown Charter High School
Los Angeles, California, 90001, United States
USC Hybrid High School
Los Angeles, California, 90037, United States
South LA College Prep
Los Angeles, California, 90044, United States
Larchmont Charter School
Los Angeles, California, 90057, United States
Brio College Prep
Los Angeles, California, 90071, United States
Lynwood High School
Lynwood, California, 90262, United States
Marco Antonio Firebaugh High School
Lynwood, California, 90262, United States
Vista High School
Lynwood, California, 90262, United States
Marshall Fundamental Secondary School
Pasadena, California, 91104, United States
Blair High School
Pasadena, California, 91106, United States
Pasadena High School
Pasadena, California, 91107, United States
Rosemead High School
Rosemead, California, 91770, United States
Washington University in St. Louis
St Louis, Missouri, 63130, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harmony Rhoades, PhD
Washington University School of Medicine
Central Study Contacts
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
- Research Associate Professor
Study Record Dates
First Submitted
September 12, 2022
First Posted
September 15, 2022
Study Start
September 14, 2022
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
September 11, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share