Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
NCT ID: NCT00050622
Last Updated: 2016-09-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
154 participants
INTERVENTIONAL
2001-09-30
2005-06-30
Brief Summary
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Detailed Description
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Measures include frequency counts of positive and negative behaviors, academic productivity and accuracy in the classroom, and counselor, parent, and teacher ratings of benefits and side effects. Parents attend training sessions and implement behavioral programs at home.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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No Treatment
No Medication, No Behavior Modification (BMOD)
Placebo
Low Dose Medication Only
0.15 mg/kg methylphenidate (MPH), No BMOD
Methylphenidate 0.15 mg/kg
0.15 m/kg/dose immediate-release methylphenidate
Medium Dose Medication Only
0.3 mg/kg MPH, No BMOD
Methylphenidate 0.3 mg/kg
0.3 mg/kg/dose immediate-release methylphenidate
Higher Dose Medication Only
0.6 mg/kg MPH, No BMOD
Methylphenidate 0.6 mg/kg
0.3 mg/kg/dose immediate-release methylphenidate
Low Intensity BMOD Only
Placebo, Low Intensity BMOD
Low-Intensity BMOD
Lower-intensity behavioral treatment package.
Placebo
Low Intensity BMOD + Low Dose Medication
0.15 mg/kg MPH, Low Intensity BMOD
Methylphenidate 0.15 mg/kg
0.15 m/kg/dose immediate-release methylphenidate
Low-Intensity BMOD
Lower-intensity behavioral treatment package.
Low Intensity BMOD + Medium Dose Medication
0.3 mg/kg MPH, Low Intensity BMOD
Low-Intensity BMOD
Lower-intensity behavioral treatment package.
Methylphenidate 0.3 mg/kg
0.3 mg/kg/dose immediate-release methylphenidate
Low Intensity BMOD + Higher Dose Medication
0.6 mg/kg MPH, Low Intensity BMOD
Low-Intensity BMOD
Lower-intensity behavioral treatment package.
Methylphenidate 0.6 mg/kg
0.3 mg/kg/dose immediate-release methylphenidate
High Intensity BMOD Only
Placebo, High Intensity BMOD
High Intensity BMOD
Comprehensive high-intensity Summer Treatment Program (STP)
High Intensity BMOD + Low Dose Medication
0.15 mg/kg MPH, High Intensity BMOD
Methylphenidate 0.15 mg/kg
0.15 m/kg/dose immediate-release methylphenidate
High Intensity BMOD
Comprehensive high-intensity Summer Treatment Program (STP)
High Intensity BMOD + Medium Dose Medication
0.3 mg/kg MPH, High Intensity BMOD
Methylphenidate 0.3 mg/kg
0.3 mg/kg/dose immediate-release methylphenidate
High Intensity BMOD
Comprehensive high-intensity Summer Treatment Program (STP)
High Intensity BMOD + Higher Dose Medication
0.6 mg/kg MPH, High Intensity BMOD
Methylphenidate 0.6 mg/kg
0.3 mg/kg/dose immediate-release methylphenidate
High Intensity BMOD
Comprehensive high-intensity Summer Treatment Program (STP)
Interventions
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Methylphenidate 0.15 mg/kg
0.15 m/kg/dose immediate-release methylphenidate
Low-Intensity BMOD
Lower-intensity behavioral treatment package.
Methylphenidate 0.3 mg/kg
0.3 mg/kg/dose immediate-release methylphenidate
Placebo
Methylphenidate 0.6 mg/kg
0.3 mg/kg/dose immediate-release methylphenidate
High Intensity BMOD
Comprehensive high-intensity Summer Treatment Program (STP)
Eligibility Criteria
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Inclusion Criteria
* IQ \>= 80
Exclusion Criteria
* Medical history that would involve considerable risk in taking stimulant medication
* History or concurrent diagnosis of any of the following disorders: pervasive developmental disorder, schizophrenia or other psychotic disorders, sexual disorder, organic mental disorder, or eating disorder
5 Years
12 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Florida International University
OTHER
Responsible Party
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Principal Investigators
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William E Pelham, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor, Florida International University
Locations
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Florida International University Center for Children and Families
Miami, Florida, United States
Center for Children and Families, University at Buffalo
Buffalo, New York, United States
Countries
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References
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Fabiano, G.A., Pelham, W.E., Gnagy, E.M., Wymbs, B.T., Chacko, A., Coles, E.K., Walker, K.S., Arnold, F., Burrows-MacLean, L., Massetti, G.M., & Hoffman, M.T. (2007). The single and combined effects of multiple intensities of behavior modification and multiple intensities of methylphenidate in a classroom setting. School Psychology Review, 36(2), 195-216.
Pelham WE, Burrows-MacLean L, Gnagy EM, Fabiano GA, Coles EK, Wymbs BT, Chacko A, Walker KS, Wymbs F, Garefino A, Hoffman MT, Waxmonsky JG, Waschbusch DA. A dose-ranging study of behavioral and pharmacological treatment in social settings for children with ADHD. J Abnorm Child Psychol. 2014 Aug;42(6):1019-31. doi: 10.1007/s10802-013-9843-8.
Related Links
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Center for Children and Families Home Page
Other Identifiers
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