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

Phase 4

Recruiting

• Conditions: ADHD
• Interventions: Drug: Methylphenidate Hydrochloride ER; Behavioral: Behavioral classroom; Drug: Placebo; Behavioral: Academic Accommodations; Behavioral: General Classroom

• Registration Number: NCT05469386
• Lead Sponsor: Florida International University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-13
• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-21
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-07
• Primary Completion: 2025-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

• ADHD Diagnosis
• IQ >= 70

Exclusion Criteria

• Prior adverse reaction to methylphenidate
• Autism Spectrum disorder level 2/3
• Child is home schooled

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
General Classroom	Methylphenidate Hydrochloride ER	General classroom procedures
Academic accommodations	Methylphenidate Hydrochloride ER	Academic accommodations are used during seat work and quiz
Academic accommodations	Placebo	Academic accommodations are used during seat work and quiz
Placebo	Behavioral classroom	Placebo capsule administered in the morning
General Classroom	Placebo	General classroom procedures
Positive Behavior Support Classroom	Methylphenidate Hydrochloride ER	Positive Behavior Support Classroom procedures
Positive Behavior Support Classroom	Academic Accommodations	Positive Behavior Support Classroom procedures
Methylphenidate ER (.3 mg/kg dose)	Academic Accommodations	Methylphenidate ER (.3 mg/kg dose)administered in the morning
Academic accommodations	General Classroom	Academic accommodations are used during seat work and quiz
Methylphenidate ER (.3 mg/kg dose)	Behavioral classroom	Methylphenidate ER (.3 mg/kg dose)administered in the morning
General Classroom	Academic Accommodations	General classroom procedures
Positive Behavior Support Classroom	Placebo	Positive Behavior Support Classroom procedures
Academic accommodations	Behavioral classroom	Academic accommodations are used during seat work and quiz
Placebo	General Classroom	Placebo capsule administered in the morning
Placebo	Academic Accommodations	Placebo capsule administered in the morning
Methylphenidate ER (.3 mg/kg dose)	General Classroom	Methylphenidate ER (.3 mg/kg dose)administered in the morning

Primary Outcome Measures

Name	Time	Method
Behavioral frequency count of rule violations	Through study completion, a maximum of eight weeks	Behavioral frequency count of rule violations. Lower scores are better.
Seatwork completion	Through study completion, a maximum of eight weeks	Percentage of assigned seat work items completed correctly. Range of scores is from 0-100%. Higher scores are better.
Quiz Scores	Through study completion, a maximum of eight weeks	Percentage correct out of 10 quiz questions. Range of scores is from 0-100%. Higher scores are better.

Trial Locations

Locations (2)

FIU Center for Childern and Families; 🇺🇸 Miami, Florida, United States

Center for Children and Families; 🇺🇸 Amherst, New York, United States