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Single and Combined Effects of Behavioral, Academic, and Medication Treatments for ADHD in the Classroom

NCT05469386 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2025-08-27

No results posted yet for this 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

  • ADHD

Interventions

DRUG

Methylphenidate Hydrochloride ER

Methylphenidate Hydrochloride ER (.3 mg/kg dose q.d.)

BEHAVIORAL

Behavioral classroom

Enhanced positive behavior supports implemented in classroom

DRUG

Placebo

Placebo capsule

BEHAVIORAL

General Classroom

General education classroom procedures

BEHAVIORAL

Academic Accommodations

Accommodations are introduced to support the child's independent seat work completion and quiz scores

Sponsors & Collaborators

  • Florida International University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2025-08-08
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05469386 on ClinicalTrials.gov