Anxiety / Proud & Empowered / Depression · Interventional Study

Efficacy of a Multi-level School Intervention for LGBTQ Youth

ClinicalTrials.gov · August 10, 2026

Insufficient Information Why this matters to you Expert discussion

The material analysed did not support any firm read.

AI Summary

This is a prospective interventional study registration, not a results report. A school-based behavioral intervention (Proud & Empowered) is being evaluated in LGBTQ youth for effects on sexual minority stress, anxiety, depression, PTSD, coping, and suicidality over 12 weeks. No outcome data are presented in this registry record.

What was studied

Interventional, Randomized, Parallel, Open label, Prevention purpose. Depression, Anxiety, Post Traumatic Stress Disorder, Coping Behavior, Sexual Minority Stress, Suicidality, Substance Use, Bullying, Harassment; age from 12 Years; to 20 Years; accepts healthy volunteers. Intervention: Intervention schools. Compared with: Control schools — Active Comparator. n = 228. 22 sites: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a clinical trial registry record for an active, enrolling study with no results posted; it describes planned outcomes only, not efficacy data.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Sexual Minority Stress Inventory (assessed at Change between baseline and post-intervention/follow-up (12 weeks)); Beck Anxiety Inventory (BAI) (assessed at Change between baseline and post-intervention/follow-up (12 weeks)); PTSD Checklist for DSM-5 (PCL-5) (assessed at Change between baseline and post-intervention/follow-up (12 weeks)); Beck Depression Inventory (assessed at Change between baseline and post-intervention/follow-up (12 weeks)); Coping Strategies Inventory (assessed at Change between baseline and post-intervention/follow-up (12 weeks)); Adapted CSSRS…

DesignInterventional, Randomized, Parallel, Open label, Prevention purpose

PopulationDepression, Anxiety, Post Traumatic Stress Disorder, Coping Behavior, Sexual Minority Stress, Suicidality, Substance Use, Bullying, Harassment; age from 12 Years; to 20 Years; accepts healthy volunteers

Sample size228

InterventionIntervention schools

ComparatorControl schools — Active Comparator

Setting22 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment228

Primary outcome measure 1Sexual Minority Stress Inventory, change baseline to 12 weeks

Primary outcome measure 2Beck Anxiety Inventory (BAI), change baseline to 12 weeks

Primary outcome measure 3PTSD Checklist for DSM-5 (PCL-5), change baseline to 12 weeks

Primary outcome measure 4Beck Depression Inventory, change baseline to 12 weeks

Primary outcome measure 5Coping Strategies Inventory, change baseline to 12 weeks

Primary outcome measure 6Adapted CSSRS Suicide Questions (Columbia Suicide Severity Rating Scale), change baseline to 12 weeks

Caveats

This is a registry record only; no results are reported.
Study design details (randomization, blinding, control group, methodology) are not described in this registry excerpt.
No power calculation or sample size justification is stated.
Recruitment status is active/not recruiting, indicating enrollment has closed but results are not yet published in this registry record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

Registry lists type as INTERVENTIONAL but no comparator, randomization, or blinding details provided.

Directness

insufficient

Primary outcomes are self-report measures; clinical meaningfulness and hard outcomes not specified.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

No methodology details (allocation concealment, blinding, attrition) provided in registry record.

Sample adequacy

insufficient

Planned enrollment 228; no power calculation or justification stated in registry.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05541406). This is a study registration, not published results. Lead sponsor: Washington University School of Medicine. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 228 participants (ACTUAL). Conditions: Depression, Anxiety, Post Traumatic Stress Disorder, Coping Behavior, Sexual Minority Stress, Suicidality, Substance Use, Bullying, Harassment. Interventions: BEHAVIORAL: Proud & Empowered. Primary outcome measures: Sexual Minority Stress Inventory , Change between baseline and post-intervention/follow-up (12 weeks); Beck Anxiety Inventory (BAI) , Change between baseline and post-intervention/follow-up (12 weeks); PTSD Checklist for DSM-5 (PCL-5) , Change between baseline and post-intervention/follow-up (12 weeks); Beck Depression Inventory , Change between baseline and post-intervention/follow-up (12 weeks); Coping Strategies Inventory , Change between baseline and post-intervention/follow-up (12 weeks); Adapted CSSRS Suicide Questions (Columbia Suicide Severity Rating Scale) , Change between baseline and post-intervention/follow-up (12 weeks). Brief summary: Efficacy of a Multi-level School Intervention for LGBTQ Youth

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT05541406AnxietyWashington University School of MedicineProud & EmpoweredDepressionPost Traumatic Stress Disorder