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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05469386
• Other study ID #: 800013424
• Status: Recruiting
• Phase: Phase 4
• Start date: June 13, 2022
• Est. completion date: August 31, 2026

Study information

• Verified date: August 2023
• Source: Florida International University
• Contact: Gregory A Fabiano
• Phone: 716-359-7823
• Email: gfabiano[@]fiu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• ADHD Diagnosis

• IQ >= 70

Exclusion Criteria:

• Prior adverse reaction to methylphenidate

• Autism Spectrum disorder level 2/3

• Child is home schooled

Related Conditions & MeSH terms

• ADHD

Intervention

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

Locations

Country	Name	City	State
United States	Center for Children and Families	Amherst	New York
United States	FIU Center for Childern and Families	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida International University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral frequency count of rule violations	Behavioral frequency count of rule violations. Lower scores are better.	Through study completion, a maximum of eight weeks
Primary	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
Primary	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