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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 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.

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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.

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

FieldValue
Enrollment Target 288 participants
Start Date 2022-06-13
Est. Completion 2026-08-31
Phase Phase 4

Sponsor

Florida International University

89 total trials

What the Registry Record Tells You About NCT05469386

The ClinicalTrials.gov registry entry for NCT05469386 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 186-participant average among 75 other ADHD trials with a reported enrollment target (55% higher). The listed sponsor is Florida International University, which has 89 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.