Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
ADHD Treatment: Comparative and Combined Dosage Effects
2 other identifiers
interventional
154
1 country
2
Brief Summary
The purpose of this study is to determine the effectiveness of behavioral treatment, drug treatment, and combined treatment for children with Attention Deficit Hyperactivity Disorder (ADHD). This study will also examine the interactions between different levels of behavioral and drug treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2001
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedFirst Submitted
Initial submission to the registry
December 16, 2002
CompletedFirst Posted
Study publicly available on registry
December 17, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedResults Posted
Study results publicly available
September 30, 2016
CompletedSeptember 30, 2016
August 1, 2016
2.9 years
December 16, 2002
May 31, 2016
August 8, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Social Behavior-Negative Verbalizations
Sum of daily frequency of Verbal Abuse toward staff members, Teasing toward peers, and Cursing/Swearing as defined by a behavioral point system that doubles as an objective measure of children's behavior. All instances of these behaviors were reported and noted as they occur throughout daily activities.
Daily for 45 days
Classroom Behavior
Daily records of percentage of assigned problems completed by children in a 60-minute classroom period.
Daily for 45 days
Secondary Outcomes (1)
Treatment Satisfaction
End of Treatment
Study Arms (12)
No Treatment
PLACEBO COMPARATORNo Medication, No Behavior Modification (BMOD)
Low Dose Medication Only
ACTIVE COMPARATOR0.15 mg/kg methylphenidate (MPH), No BMOD
Medium Dose Medication Only
ACTIVE COMPARATOR0.3 mg/kg MPH, No BMOD
Higher Dose Medication Only
ACTIVE COMPARATOR0.6 mg/kg MPH, No BMOD
Low Intensity BMOD Only
ACTIVE COMPARATORPlacebo, Low Intensity BMOD
Low Intensity BMOD + Low Dose Medication
ACTIVE COMPARATOR0.15 mg/kg MPH, Low Intensity BMOD
Low Intensity BMOD + Medium Dose Medication
ACTIVE COMPARATOR0.3 mg/kg MPH, Low Intensity BMOD
Low Intensity BMOD + Higher Dose Medication
ACTIVE COMPARATOR0.6 mg/kg MPH, Low Intensity BMOD
High Intensity BMOD Only
ACTIVE COMPARATORPlacebo, High Intensity BMOD
High Intensity BMOD + Low Dose Medication
ACTIVE COMPARATOR0.15 mg/kg MPH, High Intensity BMOD
High Intensity BMOD + Medium Dose Medication
ACTIVE COMPARATOR0.3 mg/kg MPH, High Intensity BMOD
High Intensity BMOD + Higher Dose Medication
ACTIVE COMPARATOR0.6 mg/kg MPH, High Intensity BMOD
Interventions
0.15 m/kg/dose immediate-release methylphenidate
Lower-intensity behavioral treatment package.
0.3 mg/kg/dose immediate-release methylphenidate
0.3 mg/kg/dose immediate-release methylphenidate
Comprehensive high-intensity Summer Treatment Program (STP)
Eligibility Criteria
You may qualify if:
- Attention Deficit Hyperactivity Disorder
- IQ \>= 80
You may not qualify if:
- History of seizures or other neurological problems
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Florida International University Center for Children and Families
Miami, Florida, 33199, United States
Center for Children and Families, University at Buffalo
Buffalo, New York, 14214, United States
Related Publications (2)
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.
BACKGROUNDPelham 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.
PMID: 24429997BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Highly structured environment and direct observational measures were used. Additional study in natural school and home settings will be necessary.
Results Point of Contact
- Title
- William E. Pelham, Jr.
- Organization
- Florida International University
Study Officials
- PRINCIPAL INVESTIGATOR
William E Pelham, PhD
Professor, Florida International University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2002
First Posted
December 17, 2002
Study Start
September 1, 2001
Primary Completion
August 1, 2004
Study Completion
June 1, 2005
Last Updated
September 30, 2016
Results First Posted
September 30, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share