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

Study Overview
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Brief Summary
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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.

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

Conditions
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ADHD

Intervention / Treatment
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* Drug: Methylphenidate Hydrochloride ER
* Behavioral: Behavioral classroom
* Drug: Placebo
* Behavioral: General Classroom
* Behavioral: Academic Accommodations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ADHD Diagnosis IQ >= 70 Exclusion Criteria: Prior adverse reaction to methylphenidate Autism Spectrum disorder level 2/3 Child is home schooled

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo capsule administered in the morning | Behavioral: Behavioral classroom<br>* Enhanced positive behavior supports implemented in classroom<br>Behavioral: General Classroom<br>* General education classroom procedures<br>Behavioral: Academic Accommodations<br>* Accommodations are introduced to support the child's independent seat work completion and quiz scores<br>|
| Experimental: Methylphenidate ER (.3 mg/kg dose)<br>Methylphenidate ER (.3 mg/kg dose)administered in the morning | Behavioral: Behavioral classroom<br>* Enhanced positive behavior supports implemented in classroom<br>Behavioral: General Classroom<br>* General education classroom procedures<br>Behavioral: Academic Accommodations<br>* Accommodations are introduced to support the child's independent seat work completion and quiz scores<br>|
| Active Comparator: General Classroom<br>General classroom procedures | Drug: Methylphenidate Hydrochloride ER<br>* Methylphenidate Hydrochloride ER (.3 mg/kg dose q.d.)<br>Drug: Placebo<br>* Placebo capsule<br>Behavioral: Academic Accommodations<br>* Accommodations are introduced to support the child's independent seat work completion and quiz scores<br>|
| Experimental: Positive Behavior Support Classroom<br>Positive Behavior Support Classroom procedures | Drug: Methylphenidate Hydrochloride ER<br>* Methylphenidate Hydrochloride ER (.3 mg/kg dose q.d.)<br>Drug: Placebo<br>* Placebo capsule<br>Behavioral: Academic Accommodations<br>* Accommodations are introduced to support the child's independent seat work completion and quiz scores<br>|
| Experimental: Academic accommodations<br>Academic accommodations are used during seat work and quiz | Drug: Methylphenidate Hydrochloride ER<br>* Methylphenidate Hydrochloride ER (.3 mg/kg dose q.d.)<br>Behavioral: Behavioral classroom<br>* Enhanced positive behavior supports implemented in classroom<br>Drug: Placebo<br>* Placebo capsule<br>Behavioral: General Classroom<br>* General education classroom procedures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |