A Phase 4 interventional study of Methylphenidate Hydrochloride ER and Behavioral classroom in ADHD, sponsored by Florida International University. Active, not recruiting at 2 sites in United States. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-08-27.
Sponsored by Florida International University · Phase 4, Interventional, and Treatment
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.
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's planned enrollment of 288 is above the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Florida International University is the lead sponsor of 102 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo capsule administered in the morning
Behavioral: Behavioral classroom · Behavioral: General Classroom · Behavioral: Academic Accommodations
Methylphenidate ER (.3 mg/kg dose)administered in the morning
Behavioral: Behavioral classroom · Behavioral: General Classroom · Behavioral: Academic Accommodations
General classroom procedures
Drug: Methylphenidate Hydrochloride ER · Drug: Placebo · Behavioral: Academic Accommodations
Positive Behavior Support Classroom procedures
Drug: Methylphenidate Hydrochloride ER · Drug: Placebo · Behavioral: Academic Accommodations
Academic accommodations are used during seat work and quiz
Drug: Methylphenidate Hydrochloride ER · Behavioral: Behavioral classroom · Drug: Placebo · Behavioral: General Classroom
Methylphenidate Hydrochloride ER (.3 mg/kg dose q.d.)
Enhanced positive behavior supports implemented in classroom
Placebo capsule
General education classroom procedures
Accommodations are introduced to support the child's independent seat work completion and quiz scores
Behavioral frequency count of rule violations
Behavioral frequency count of rule violations. Lower scores are better.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, a maximum of eight weeks
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity→
Florida International University