DepressionNCT05541406
Efficacy of a Multi-level School Intervention for LGBTQ Youth
A study testing Proud & Empowered in people with Depression and Anxiety, run by Washington University School of Medicine at 23 sites in United States.
Trial summary
Efficacy of a Multi-level School Intervention for LGBTQ Youth Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Post Traumatic Stress Disorder
- What is being tested?
- Proud & Empowered
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 23 sitesUnited States
- Study dates
- 14 Sep 2022to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- LGBTQ student in one of 24 high schools
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
United States23 sites, 1 recruiting
- Completed
El Monte High School
El Monte, California, 91731
- Completed
Arroyo High School
El Monte, California, 91732
- Completed
Fernando R Ledesma High School
El Monte, California, 91732
- Completed
Mountain View High School
El Monte, California, 91732
- Completed
South El Monte High School
El Monte, California, 91733
- Completed
Anderson W. Clark Magnet High School
Glendale, California, 91214
- Completed
Inglewood High School
Inglewood, California, 90303
- Completed
Animo Leadership High School
Inglewood, California, 90304
- Completed
Crescenta Valley High School
La Crescenta-Montrose, California, 91214
- Completed
Millikan High School
Long Beach, California, 90815
- Completed
Animo Pat Brown Charter High School
Los Angeles, California, 90001
- Completed
USC Hybrid High School
Los Angeles, California, 90037
- Completed
South LA College Prep
Los Angeles, California, 90044
- Completed
Larchmont Charter School
Los Angeles, California, 90057
- Completed
Brio College Prep
Los Angeles, California, 90071
- Completed
Lynwood High School
Lynwood, California, 90262
- Completed
Marco Antonio Firebaugh High School
Lynwood, California, 90262
- Completed
Vista High School
Lynwood, California, 90262
- Completed
Marshall Fundamental Secondary School
Pasadena, California, 91104
- Completed
Blair High School
Pasadena, California, 91106
- Completed
Pasadena High School
Pasadena, California, 91107
- Completed
Rosemead High School
Rosemead, California, 91770
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63130
Bethany Lumsdaine, MPH, b.lumsdaine@wustl.edu
About this study
Efficacy of a Multi-level School Intervention for LGBTQ Youth
Read the 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.
- Conditions
- Depression, Anxiety, Post Traumatic Stress Disorder, Coping Behavior, Sexual Minority Stress, Suicidality
- Being tested
- Proud & Empowered, Control Group
- Keywords
- LGBTQ+ Youth, LGBT Youth, Queer Youth
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic, Suicidal Ideation, Substance-Related Disorders, Bullying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proud & EmpoweredBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention schools | Experimental | Schools will be assigned to either intervention or control schools. Students in intervention schools will receive the intervention in semester 1. Receives: Behavioral: Proud & Empowered |
| Control schools | Active comparator | Students in control schools will receive no intervention Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change between baseline and post-intervention/follow-up (12 weeks)
Secondary outcomes (2)
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.
Measured: Change between baseline and post-intervention/follow-up (12 weeks)
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.
Measured: Change between baseline and post-intervention/follow-up (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start14 Sep 2022
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), University of Southern California
- Responsible party
- Principal investigator, Harmony Rhoades, Washington University School of Medicine
- Investigators
- Harmony Rhoades, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541406
- Sponsor's protocol ID
- 202208172
- Other IDs
- 1R01MD016082-01A1
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Multi-level School Intervention for LGBTQ Youth
- ClinicalTrials.gov ID
- NCT05541406
- Acronym / sponsor ID
- 202208172
- Conditions
- Depression, Anxiety, Post Traumatic Stress Disorder, Coping Behavior, Sexual Minority Stress, Suicidality
- Keywords
- LGBTQ+ Youth, LGBT Youth, Queer Youth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), University of Southern California
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention schools | Experimental | Behavioral: Proud & EmpoweredSchools will be assigned to either intervention or control schools. Students in intervention schools will receive the intervention in semester 1. |
| Control schools | Active comparator | Behavioral: Control GroupStudents in control schools will receive no intervention |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- LGBTQ student in one of 24 high schools
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proud & EmpoweredProud \& 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. | Behavioural | Intervention schools |
| Control GroupSchools 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. | Behavioural | Control schools |
Primary outcome
Sexual Minority Stress Inventory
Time frame: Change between baseline and post-intervention/follow-up (12 weeks)
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)
Time frame: Change between baseline and post-intervention/follow-up (12 weeks)
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)
Time frame: Change between baseline and post-intervention/follow-up (12 weeks)
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
Time frame: Change between baseline and post-intervention/follow-up (12 weeks)
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
Time frame: Change between baseline and post-intervention/follow-up (12 weeks)
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)
Time frame: Change between baseline and post-intervention/follow-up (12 weeks)
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.
2 secondary outcomes
Youth Risk Behavior Survey Substance Use Questions
Time frame: Change between baseline and post-intervention/follow-up (12 weeks)
California Healthy Kids Survey General Bullying and Gender Identity/Sexual Orientation-Based Harassment Module
Time frame: Change between baseline and post-intervention/follow-up (12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Harmony Rhoades, PhD principal investigator
Washington University School of Medicine
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proud & Empowered in people with Depression and Anxiety, run by Washington University School of Medicine at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bethany N Lumsdaine, MPH (3103826003, b.lumsdaine@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Minority Stress Inventory (time frame: Change between baseline and post-intervention/follow-up (12 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.