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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Florida International University
ClinicalTrials.gov Identifier:
NCT00050622
First received: December 16, 2002
Last updated: August 8, 2016
Last verified: August 2016
  Purpose
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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ADHD Treatment: Comparative and Combined Dosage Effects

Resource links provided by NLM:


Further study details as provided by Florida International University:

Primary Outcome Measures:
  • Social Behavior-Negative Verbalizations [ Time Frame: Daily for 45 days ] [ Designated as safety issue: No ]
    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.

  • Classroom Behavior [ Time Frame: Daily for 45 days ] [ Designated as safety issue: No ]
    Daily records of percentage of assigned problems completed by children in a 60-minute classroom period.


Secondary Outcome Measures:
  • Treatment Satisfaction [ Time Frame: End of Treatment ] [ Designated as safety issue: No ]
    Parent rating of treatment satisfaction with medication, behavioral treatment, and their combination,on a scale of 1 (bad) to 7 (good).


Enrollment: 154
Study Start Date: September 2001
Study Completion Date: June 2005
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years   (Child)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050622

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:
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.

Responsible Party: Florida International University
ClinicalTrials.gov Identifier: NCT00050622     History of Changes
Other Study ID Numbers: R01MH062946  DSIR CT-CT 
Study First Received: December 16, 2002
Results First Received: May 31, 2016
Last Updated: August 8, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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

ClinicalTrials.gov processed this record on December 07, 2016