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NCT Number: NCT05469386

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

FIU Center for Childern and Families, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ADHD Diagnosis
  • IQ >= 70

Exclusion criteria

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

Treatment and study plan

Methylphenidate Hydrochloride ER

Drug

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

Behavioral classroom

Behavioral

Enhanced positive behavior supports implemented in classroom

Placebo

Drug

Placebo capsule

General Classroom

Behavioral

General education classroom procedures

Academic Accommodations

Behavioral

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

Primary outcomes

  1. Behavioral frequency count of rule violations

    Time frame: Through study completion, a maximum of eight weeks

    Behavioral frequency count of rule violations. Lower scores are better.

  2. Seatwork completion

    Time frame: 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.

  3. Quiz Scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jul 21, 2022
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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