Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05469386 · ClinicalTrials.gov registry record · Phase 4
Single and Combined Effects of Behavioral, Academic, and Medication Treatments for ADHD in the Classroom
A Phase 4 study of ADHD, sponsored by Florida International University.
- Active
- Registry status
- Phase 4
- Development phase
- 288
- Enrollment target
- 2
- Study locations
NCT05469386: Active Phase 4 study of ADHD, sponsored by Florida International University.
NCT05469386 is a Phase 4 study of ADHD that is active but no longer recruiting, run by Florida International University. The registered enrollment target is 288 participants, above the 186-participant average among 75 other ADHD trials with a reported enrollment target (55% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05469386, a Phase 4 study of ADHD, is active but no longer recruiting, sponsored by Florida International University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 288 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study is the first to systematically evaluate the efficacy of single and combined academic accommodation, behavioral treatment, and medication treatment in a large sample of children with ADHD. Using a scientifically rigorous, cross-over design the impact of these approaches on ecologically valid measures of outcome (on-task behavior, quiz scores, academic productivity) will be assessed to inform effective school intervention.
Primary Outcome
Behavioral frequency count of rule violations. Lower scores are better.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Methylphenidate Hydrochloride ER
- BEHAVIORAL Behavioral classroom
- BEHAVIORAL General Classroom
- BEHAVIORAL Academic Accommodations
Study Locations (2)
Florida
- FIU Center for Childern and Families - Miami
New York
- Center for Children and Families - Amherst
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2022-06-13 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 4 |
What the registry record for NCT05469386 still lists
NCT05469386 is an interventional study that assigns participants to a tested intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap, above the 186-participant average among 75 other ADHD trials with a reported enrollment target (55% higher).
The record links to 1 condition, with ADHD appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT05469386 reports a single indexed study location in Florida, New York.
Frequently Asked Questions
What is clinical trial NCT05469386 about?
NCT05469386 is a clinical study titled "Single and Combined Effects of Behavioral, Academic, and Medication Treatments for ADHD in the Classroom". This study is the first to systematically evaluate the efficacy of single and combined academic accommodation, behavioral treatment, and medication treatment in a large sample of children with ADHD. Using a scientifically rigorous, cross-over design the impact of these approaches on ecologically val...
What is the current status of trial NCT05469386?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 288 participants. The study started on 2022-06-13. Estimated completion is 2026-08-31.
What conditions does trial NCT05469386 study?
This clinical trial studies the following conditions: ADHD.
What interventions are being tested in trial NCT05469386?
The interventions under investigation include: Placebo (DRUG), Methylphenidate Hydrochloride ER (DRUG), Behavioral classroom (BEHAVIORAL), General Classroom (BEHAVIORAL), Academic Accommodations (BEHAVIORAL).
Who is sponsoring clinical trial NCT05469386?
This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05469386 being conducted?
This trial has 2 study locations across Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for ADHD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05469386's enrollment target sits among peer trials
288 13th of 75 higher than 62 of 75 other ADHD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other ADHD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
RECRUITING · Phase 4
-
Evaluating Treatment of ADHD in Children with Down Syndrome
RECRUITING · Phase 4
-
Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD
RECRUITING · Phase 4
-
AWARE: Management of ADHD in Autism Spectrum Disorder
RECRUITING · Phase 4
-
A Double-Blind Comparison of Concerta and Placebo in Adults With Attention Deficit Hyperactivity Disorder
COMPLETED · Phase 4
-
Evaluation of an Intervention for Improving Community-based Pediatric Attention-Deficit Hyperactivity Disorder (ADHD) Care
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02098265 · 288 participants · NA
A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
- NCT03741777 · 288 participants · NA
Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume
- NCT03937635 · 288 participants · Phase 3
Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma
- NCT04621877 · 288 participants · NA
Lay-Delivered Behavioral Activation in Senior Centers
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI