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

NCT05469386 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 800013424
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 2

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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo capsule administered in the morning

Behavioral: Behavioral classroom; Behavioral: General Classroom; Behavioral: Academic Accommodations

Methylphenidate ER (.3 mg/kg dose)

EXPERIMENTAL

Methylphenidate ER (.3 mg/kg dose)administered in the morning

Behavioral: Behavioral classroom; Behavioral: General Classroom; Behavioral: Academic Accommodations

General Classroom

ACTIVE COMPARATOR

General classroom procedures

Drug: Methylphenidate Hydrochloride ER; Drug: Placebo; Behavioral: Academic Accommodations

Positive Behavior Support Classroom

EXPERIMENTAL

Positive Behavior Support Classroom procedures

Drug: Methylphenidate Hydrochloride ER; Drug: Placebo; Behavioral: Academic Accommodations

Academic accommodations

EXPERIMENTAL

Academic accommodations are used during seat work and quiz

Drug: Methylphenidate Hydrochloride ER; Behavioral: Behavioral classroom; Drug: Placebo; Behavioral: General Classroom

Interventions

Methylphenidate Hydrochloride ER DRUG

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

Academic accommodations; General Classroom; Positive Behavior Support Classroom

Behavioral classroom BEHAVIORAL

Enhanced positive behavior supports implemented in classroom

Academic accommodations; Methylphenidate ER (.3 mg/kg dose); Placebo

Placebo DRUG

Placebo capsule

Academic accommodations; General Classroom; Positive Behavior Support Classroom

General Classroom BEHAVIORAL

General education classroom procedures

Academic accommodations; Methylphenidate ER (.3 mg/kg dose); Placebo

Academic Accommodations BEHAVIORAL

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

General Classroom; Methylphenidate ER (.3 mg/kg dose); Placebo; Positive Behavior Support Classroom

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ADHD Diagnosis
• IQ \>= 70

You may not qualify if:

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

Sponsors & Collaborators

• Florida International University: lead

Study Sites (2)

FIU Center for Childern and Families

Miami, Florida, 33199, United States

Location

Center for Children and Families

Amherst, New York, 14226, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 21, 2022
• Study Start: June 13, 2022
• Primary Completion: August 8, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

US (2)