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

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.

Study Overview

• Status: Recruiting
• Conditions: ADHD
• Intervention / Treatment: Drug: Placebo; Behavioral: Behavioral classroom; Behavioral: General Classroom; Behavioral: Academic Accommodations; Drug: Methylphenidate Hydrochloride ER

• Study Type: Interventional
• Enrollment (Estimated): 288
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Gregory A Fabiano; Phone Number: 716-359-7823; Email: gfabiano@fiu.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33199
      • Recruiting
      • FIU Center for Childern and Families
      • Contact: William E Pelham, PhD
  • New York
    • Amherst, New York, United States, 14226
      • Recruiting
      • Center for Children and Families
      • Contact: Gregory A Fabiano, PhD; Phone Number: 716-359-7823; Email: gfabiano@fiu.edu
      • Contact: Devon Tower; Phone Number: 716-359-7500; Email: dtower@fiu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ADHD Diagnosis
• IQ >= 70

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo capsule administered in the morning	Behavioral: Behavioral classroom; Enhanced positive behavior supports implemented in classroom; 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
Experimental: Methylphenidate ER (.3 mg/kg dose); Methylphenidate ER (.3 mg/kg dose)administered in the morning	Behavioral: Behavioral classroom; Enhanced positive behavior supports implemented in classroom; 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
Active Comparator: General Classroom; General classroom procedures	Drug: Placebo; Placebo capsule; Behavioral: Academic Accommodations; Accommodations are introduced to support the child's independent seat work completion and quiz scores; Drug: Methylphenidate Hydrochloride ER; Methylphenidate Hydrochloride ER (.3 mg/kg dose q.d.)
Experimental: Positive Behavior Support Classroom; Positive Behavior Support Classroom procedures	Drug: Placebo; Placebo capsule; Behavioral: Academic Accommodations; Accommodations are introduced to support the child's independent seat work completion and quiz scores; Drug: Methylphenidate Hydrochloride ER; Methylphenidate Hydrochloride ER (.3 mg/kg dose q.d.)
Experimental: Academic accommodations; Academic accommodations are used during seat work and quiz	Drug: Placebo; Placebo capsule; Behavioral: Behavioral classroom; Enhanced positive behavior supports implemented in classroom; Behavioral: General Classroom; General education classroom procedures; Drug: Methylphenidate Hydrochloride ER; Methylphenidate Hydrochloride ER (.3 mg/kg dose q.d.)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Florida International University

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: 800013424

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No