NCT05469386

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

Single and Combined Effects of Positive Behavior Support, Medication and Academic Accommodation for Children With ADHD

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: Florida International University · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-06-13
• Primary completion: 2025-08-08
• Completion: 2026-08-31
• First posted: 2022-07-21
• Last updated: 2025-08-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study