Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

ADHD Treatment: Comparative and Combined Dosage Effects

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Drug: Placebo; Drug: Methylphenidate 0.15 mg/kg; Drug: Methylphenidate 0.3 mg/kg; Drug: Methylphenidate 0.6 mg/kg; Behavioral: Low-Intensity BMOD; Behavioral: High Intensity BMOD

Detailed Description

Participants attend a summer treatment program each Monday-Friday for 9 weeks. They participate in group recreational and classroom activities, with 12 children and 5 staff per group. Three behavioral conditions (no behavioral modification, low-intensity behavioral modification, and high-intensity behavioral modification) are delivered in random order, with each condition lasting 3 weeks. Along with the behavioral treatment conditions, children receive 1 of 4 medication doses (placebo, 0.15 mg/kg methylphenidate, 0.3 mg/kg methylphenidate, or 0.6 mg/kg methylphenidate) in random order, with each dose varied daily and repeated 3 or 4 times within each behavioral treatment condition.

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.

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33199
      • Florida International University Center for Children and Families
  • New York
    • Buffalo, New York, United States, 14214
      • Center for Children and Families, University at Buffalo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Attention Deficit Hyperactivity Disorder
• IQ >= 80

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: No Treatment; No Medication, No Behavior Modification (BMOD)	Drug: Placebo
Active Comparator: Low Dose Medication Only; 0.15 mg/kg methylphenidate (MPH), No BMOD	Drug: Methylphenidate 0.15 mg/kg; 0.15 m/kg/dose immediate-release methylphenidate
Active Comparator: Medium Dose Medication Only; 0.3 mg/kg MPH, No BMOD	Drug: Methylphenidate 0.3 mg/kg; 0.3 mg/kg/dose immediate-release methylphenidate
Active Comparator: Higher Dose Medication Only; 0.6 mg/kg MPH, No BMOD	Drug: Methylphenidate 0.6 mg/kg; 0.3 mg/kg/dose immediate-release methylphenidate
Active Comparator: Low Intensity BMOD Only; Placebo, Low Intensity BMOD	Drug: Placebo; Behavioral: Low-Intensity BMOD; Lower-intensity behavioral treatment package.
Active Comparator: Low Intensity BMOD + Low Dose Medication; 0.15 mg/kg MPH, Low Intensity BMOD	Drug: Methylphenidate 0.15 mg/kg; 0.15 m/kg/dose immediate-release methylphenidate; Behavioral: Low-Intensity BMOD; Lower-intensity behavioral treatment package.
Active Comparator: Low Intensity BMOD + Medium Dose Medication; 0.3 mg/kg MPH, Low Intensity BMOD	Drug: Methylphenidate 0.3 mg/kg; 0.3 mg/kg/dose immediate-release methylphenidate; Behavioral: Low-Intensity BMOD; Lower-intensity behavioral treatment package.
Active Comparator: Low Intensity BMOD + Higher Dose Medication; 0.6 mg/kg MPH, Low Intensity BMOD	Drug: Methylphenidate 0.6 mg/kg; 0.3 mg/kg/dose immediate-release methylphenidate; Behavioral: Low-Intensity BMOD; Lower-intensity behavioral treatment package.
Active Comparator: High Intensity BMOD Only; Placebo, High Intensity BMOD	Behavioral: High Intensity BMOD; Comprehensive high-intensity Summer Treatment Program (STP)
Active Comparator: High Intensity BMOD + Low Dose Medication; 0.15 mg/kg MPH, High Intensity BMOD	Drug: Methylphenidate 0.15 mg/kg; 0.15 m/kg/dose immediate-release methylphenidate; Behavioral: High Intensity BMOD; Comprehensive high-intensity Summer Treatment Program (STP)
Active Comparator: High Intensity BMOD + Medium Dose Medication; 0.3 mg/kg MPH, High Intensity BMOD	Drug: Methylphenidate 0.3 mg/kg; 0.3 mg/kg/dose immediate-release methylphenidate; Behavioral: High Intensity BMOD; Comprehensive high-intensity Summer Treatment Program (STP)
Active Comparator: High Intensity BMOD + Higher Dose Medication; 0.6 mg/kg MPH, High Intensity BMOD	Drug: Methylphenidate 0.6 mg/kg; 0.3 mg/kg/dose immediate-release methylphenidate; Behavioral: High Intensity BMOD; Comprehensive high-intensity Summer Treatment Program (STP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Satisfaction	Parent rating of treatment satisfaction with medication, behavioral treatment, and their combination,on a scale of 1 (bad) to 7 (good).	End of Treatment

Collaborators and Investigators

• Sponsor: Florida International University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: William E Pelham, PhD, Professor, Florida International University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Center for Children and Families Home Page

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Primary Completion (Actual): August 1, 2004
• Study Completion (Actual): June 1, 2005

Study Registration Dates

• First Submitted: December 16, 2002
• First Submitted That Met QC Criteria: December 16, 2002
• First Posted (Estimate): December 17, 2002

Study Record Updates

• Last Update Posted (Estimate): September 30, 2016
• Last Update Submitted That Met QC Criteria: August 8, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: R01MH062946 (U.S. NIH Grant/Contract); DSIR CT-CT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES