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

• ClinicalTrials.gov Identifier: NCT00050622
• Recruitment Status: Completed
• First Posted: December 17, 2002
• Results First Posted: September 30, 2016
• Last Update Posted: September 30, 2016
• Sponsor: Florida International University
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Florida International University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Attention Deficit Disorder With Hyperactivity	Drug: Methylphenidate 0.15 mg/kg; Behavioral: Low-Intensity BMOD; Drug: Methylphenidate 0.3 mg/kg; Drug: Placebo; Drug: Methylphenidate 0.6 mg/kg; Behavioral: High Intensity BMOD	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: ADHD Treatment: Comparative and Combined Dosage Effects
• Study Start Date: September 2001
• Actual Primary Completion Date: August 2004
• Actual Study Completion Date: June 2005

Arms and Interventions

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	Behavioral: Low-Intensity BMOD; Lower-intensity behavioral treatment package.; Drug: Placebo
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	Behavioral: Low-Intensity BMOD; Lower-intensity behavioral treatment package.; Drug: Methylphenidate 0.3 mg/kg; 0.3 mg/kg/dose immediate-release methylphenidate
Active Comparator: Low Intensity BMOD + Higher Dose Medication; 0.6 mg/kg MPH, Low Intensity BMOD	Behavioral: Low-Intensity BMOD; Lower-intensity behavioral treatment package.; Drug: Methylphenidate 0.6 mg/kg; 0.3 mg/kg/dose immediate-release methylphenidate
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)

Outcome Measures

Primary Outcome Measures :

1. Social Behavior-Negative Verbalizations [ Time Frame: Daily for 45 days ]
   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.
2. Classroom Behavior [ Time Frame: Daily for 45 days ]
   Daily records of percentage of assigned problems completed by children in a 60-minute classroom period.

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Florida

Florida International University Center for Children and Families

Miami, Florida, United States, 33199

United States, New York

Center for Children and Families, University at Buffalo

Buffalo, New York, United States, 14214

Sponsors and Collaborators

Florida International University

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: William E Pelham, PhD; Professor, Florida International University

More Information

Additional Information:

Center for Children and Families Home Page 

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.

• Responsible Party: Florida International University
• ClinicalTrials.gov Identifier: NCT00050622
• Other Study ID Numbers: R01MH062946 ( U.S. NIH Grant/Contract ); R01MH062946 ( U.S. NIH Grant/Contract ); DSIR CT-CT
• First Posted: December 17, 2002
• Results First Posted: September 30, 2016
• Last Update Posted: September 30, 2016
• Last Verified: August 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Additional relevant MeSH terms:

Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Methylphenidate; Central Nervous System Stimulants; Physiological Effects of Drugs; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents