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Efficacy of a Multi-level School Intervention for LGBTQ Youth

Primary Purpose

Depression, Anxiety, Post Traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proud & Empowered
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring LGBTQ+ Youth, LGBT Youth, Queer Youth

Eligibility Criteria

12 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • LGBTQ student in one of 24 high schools

Exclusion Criteria:

  • Not meeting inclusion criteria

Sites / Locations

  • El Monte High SchoolRecruiting
  • Arroyo High School
  • Fernando R Ledesma High School
  • Mountain View High SchoolRecruiting
  • South El Monte High School
  • Crescenta Valley High School
  • Woodrow Wilson High SchoolRecruiting
  • Millikan High SchoolRecruiting
  • USC Hybrid High SchoolRecruiting
  • South LA College PrepRecruiting
  • Larchmont Charter SchoolRecruiting
  • Lynwood High SchoolRecruiting
  • Marco Antonio Firebaugh High School
  • Vista High SchoolRecruiting
  • Marshall Fundamental Secondary SchoolRecruiting
  • Blair High School
  • Pasadena High School
  • Rosemead High School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention schools

Control schools

Arm Description

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

Students in control schools will receive no intervention

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Youth Risk Behavior Survey Substance Use Questions
Measures individual's usage of various substances in their lifetime and within the past 30 days as well as the ways in which individuals have used marijuana, tobacco, or nicotine in the past 30 days. Each substance is individually analyzed for both lifetime usage and past 30 day usage. Individuals can answer Yes or No for both lifetime usage and past 30 day usage. Each substance can range from 0 to the maximum number of survey responses. In addition, for marijuana, students can specify the way in which they used it with response options of smoking, vaping, edible or beverage form, or other. For nicotine and tobacco, students can specify the way in which they used it with the response options of smoking, vaping, or other. "Yes" responses indicate a worse outcome indicating that individuals have used or are currently using the substance in question.
California Healthy Kids Survey General Bullying and Gender Identity/Sexual Orientation-Based Harassment Module
Assesses students' perceptions of harassment experiences on school campus among the general student population in addition to bullying and harassment experiences on school campus specific of students who identify as, or are perceived to be, lesbian, gay, bisexual, transgender, questioning, or gender nonconforming.

Full Information

First Posted
September 12, 2022
Last Updated
October 6, 2023
Sponsor
Washington University School of Medicine
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT05541406
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Post Traumatic Stress Disorder, Coping Behavior, Sexual Minority Stress, Suicidality, Substance Use, Bullying, Harassment
Keywords
LGBTQ+ Youth, LGBT Youth, Queer Youth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention schools
Arm Type
Experimental
Arm Description
Schools will be assigned to either intervention or control schools. Students in intervention schools will receive the intervention in semester 1.
Arm Title
Control schools
Arm Type
Active Comparator
Arm Description
Students in control schools will receive no intervention
Intervention Type
Behavioral
Intervention Name(s)
Proud & Empowered
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sexual Minority Stress Inventory
Description
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.
Time Frame
Change between baseline and post-intervention/follow-up (12 weeks)
Title
Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
Change between baseline and post-intervention/follow-up (12 weeks)
Title
PTSD Checklist for DSM-5 (PCL-5)
Description
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.
Time Frame
Change between baseline and post-intervention/follow-up (12 weeks)
Title
Beck Depression Inventory
Description
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.
Time Frame
Change between baseline and post-intervention/follow-up (12 weeks)
Title
Coping Strategies Inventory
Description
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.
Time Frame
Change between baseline and post-intervention/follow-up (12 weeks)
Title
Adapted CSSRS Suicide Questions (Columbia Suicide Severity Rating Scale)
Description
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.
Time Frame
Change between baseline and post-intervention/follow-up (12 weeks)
Secondary Outcome Measure Information:
Title
Youth Risk Behavior Survey Substance Use Questions
Description
Measures individual's usage of various substances in their lifetime and within the past 30 days as well as the ways in which individuals have used marijuana, tobacco, or nicotine in the past 30 days. Each substance is individually analyzed for both lifetime usage and past 30 day usage. Individuals can answer Yes or No for both lifetime usage and past 30 day usage. Each substance can range from 0 to the maximum number of survey responses. In addition, for marijuana, students can specify the way in which they used it with response options of smoking, vaping, edible or beverage form, or other. For nicotine and tobacco, students can specify the way in which they used it with the response options of smoking, vaping, or other. "Yes" responses indicate a worse outcome indicating that individuals have used or are currently using the substance in question.
Time Frame
Change between baseline and post-intervention/follow-up (12 weeks)
Title
California Healthy Kids Survey General Bullying and Gender Identity/Sexual Orientation-Based Harassment Module
Description
Assesses students' perceptions of harassment experiences on school campus among the general student population in addition to bullying and harassment experiences on school campus specific of students who identify as, or are perceived to be, lesbian, gay, bisexual, transgender, questioning, or gender nonconforming.
Time Frame
Change between baseline and post-intervention/follow-up (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: LGBTQ student in one of 24 high schools Exclusion Criteria: Not meeting inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John G Senese IV, MSW
Phone
(917) 815-1242
Email
senese@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Goldbach, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
El Monte High School
City
El Monte
State/Province
California
ZIP/Postal Code
91731
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John G Senese IV, MSW
Phone
917-719-5691
Email
senese@wustl.edu
Facility Name
Arroyo High School
City
El Monte
State/Province
California
ZIP/Postal Code
91732
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Fernando R Ledesma High School
City
El Monte
State/Province
California
ZIP/Postal Code
91732
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mountain View High School
City
El Monte
State/Province
California
ZIP/Postal Code
91732
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John G Senese IV, MSW
Phone
917-719-5691
Email
senese@wustl.edu
Facility Name
South El Monte High School
City
El Monte
State/Province
California
ZIP/Postal Code
91733
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Crescenta Valley High School
City
La Crescenta-Montrose
State/Province
California
ZIP/Postal Code
91214
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Woodrow Wilson High School
City
Long Beach
State/Province
California
ZIP/Postal Code
90804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John G Senese IV, MSW
Phone
917-719-5691
Email
senese@wustl.edu
Facility Name
Millikan High School
City
Long Beach
State/Province
California
ZIP/Postal Code
90815
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John G Senese IV, MSW
Phone
917-719-5691
Email
senese@wustl.edu
Facility Name
USC Hybrid High School
City
Los Angeles
State/Province
California
ZIP/Postal Code
90037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John G Senese IV, MSW
Phone
917-719-5691
Email
senese@wustl.edu
Facility Name
South LA College Prep
City
Los Angeles
State/Province
California
ZIP/Postal Code
90044
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John G Senese IV, MSW
Phone
917-719-5691
Email
senese@wustl.edu
Facility Name
Larchmont Charter School
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John G Senese IV, MSW
Phone
917-719-5691
Email
senese@wustl.edu
Facility Name
Lynwood High School
City
Lynwood
State/Province
California
ZIP/Postal Code
90262
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John G Senese IV, MSW
Phone
917-719-5691
Email
senese@wustl.edu
Facility Name
Marco Antonio Firebaugh High School
City
Lynwood
State/Province
California
ZIP/Postal Code
90262
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Vista High School
City
Lynwood
State/Province
California
ZIP/Postal Code
90262
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John G Senese IV, MSW
Phone
917-719-5691
Email
senese@wustl.edu
Facility Name
Marshall Fundamental Secondary School
City
Pasadena
State/Province
California
ZIP/Postal Code
91104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John G Senese IV, MSW
Phone
917-719-5691
Email
senese@wustl.edu
Facility Name
Blair High School
City
Pasadena
State/Province
California
ZIP/Postal Code
91106
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Pasadena High School
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Rosemead High School
City
Rosemead
State/Province
California
ZIP/Postal Code
91770
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of a Multi-level School Intervention for LGBTQ Youth

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