Single and Combined Effects of Behavioral, Academic, and Medication Treatments for ADHD in the Classroom
NCT ID: NCT05469386
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
288 participants
INTERVENTIONAL
2022-06-13
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo capsule administered in the morning
Behavioral classroom
Enhanced positive behavior supports implemented in classroom
General Classroom
General education classroom procedures
Academic Accommodations
Accommodations are introduced to support the child's independent seat work completion and quiz scores
Methylphenidate ER (.3 mg/kg dose)
Methylphenidate ER (.3 mg/kg dose)administered in the morning
Behavioral classroom
Enhanced positive behavior supports implemented in classroom
General Classroom
General education classroom procedures
Academic Accommodations
Accommodations are introduced to support the child's independent seat work completion and quiz scores
General Classroom
General classroom procedures
Methylphenidate Hydrochloride ER
Methylphenidate Hydrochloride ER (.3 mg/kg dose q.d.)
Placebo
Placebo capsule
Academic Accommodations
Accommodations are introduced to support the child's independent seat work completion and quiz scores
Positive Behavior Support Classroom
Positive Behavior Support Classroom procedures
Methylphenidate Hydrochloride ER
Methylphenidate Hydrochloride ER (.3 mg/kg dose q.d.)
Placebo
Placebo capsule
Academic Accommodations
Accommodations are introduced to support the child's independent seat work completion and quiz scores
Academic accommodations
Academic accommodations are used during seat work and quiz
Methylphenidate Hydrochloride ER
Methylphenidate Hydrochloride ER (.3 mg/kg dose q.d.)
Behavioral classroom
Enhanced positive behavior supports implemented in classroom
Placebo
Placebo capsule
General Classroom
General education classroom procedures
Interventions
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Methylphenidate Hydrochloride ER
Methylphenidate Hydrochloride ER (.3 mg/kg dose q.d.)
Behavioral classroom
Enhanced positive behavior supports implemented in classroom
Placebo
Placebo capsule
General Classroom
General education classroom procedures
Academic Accommodations
Accommodations are introduced to support the child's independent seat work completion and quiz scores
Eligibility Criteria
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Inclusion Criteria
* IQ \>= 70
Exclusion Criteria
* Autism Spectrum disorder level 2/3
* Child is home schooled
5 Years
12 Years
ALL
No
Sponsors
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Florida International University
OTHER
Responsible Party
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Locations
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FIU Center for Childern and Families
Miami, Florida, United States
Center for Children and Families
Amherst, New York, United States
Countries
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Other Identifiers
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800013424
Identifier Type: -
Identifier Source: org_study_id
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