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

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate 0.15 mg/kg
Low-Intensity BMOD
Methylphenidate 0.3 mg/kg
Placebo
Methylphenidate 0.6 mg/kg
High Intensity BMOD
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florida International University Center for Children and Families
  • Center for Children and Families, University at Buffalo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

No Treatment

Low Dose Medication Only

Medium Dose Medication Only

Higher Dose Medication Only

Low Intensity BMOD Only

Low Intensity BMOD + Low Dose Medication

Low Intensity BMOD + Medium Dose Medication

Low Intensity BMOD + Higher Dose Medication

High Intensity BMOD Only

High Intensity BMOD + Low Dose Medication

High Intensity BMOD + Medium Dose Medication

High Intensity BMOD + Higher Dose Medication

Arm Description

No Medication, No Behavior Modification (BMOD)

0.15 mg/kg methylphenidate (MPH), No BMOD

0.3 mg/kg MPH, No BMOD

0.6 mg/kg MPH, No BMOD

Placebo, Low Intensity BMOD

0.15 mg/kg MPH, Low Intensity BMOD

0.3 mg/kg MPH, Low Intensity BMOD

0.6 mg/kg MPH, Low Intensity BMOD

Placebo, High Intensity BMOD

0.15 mg/kg MPH, High Intensity BMOD

0.3 mg/kg MPH, High Intensity BMOD

0.6 mg/kg MPH, High Intensity BMOD

Outcomes

Primary Outcome Measures

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.
Classroom Behavior
Daily records of percentage of assigned problems completed by children in a 60-minute classroom period.

Secondary Outcome Measures

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

Full Information

First Posted
December 16, 2002
Last Updated
August 8, 2016
Sponsor
Florida International University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00050622
Brief Title
Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
Official Title
ADHD Treatment: Comparative and Combined Dosage Effects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida International University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Treatment
Arm Type
Placebo Comparator
Arm Description
No Medication, No Behavior Modification (BMOD)
Arm Title
Low Dose Medication Only
Arm Type
Active Comparator
Arm Description
0.15 mg/kg methylphenidate (MPH), No BMOD
Arm Title
Medium Dose Medication Only
Arm Type
Active Comparator
Arm Description
0.3 mg/kg MPH, No BMOD
Arm Title
Higher Dose Medication Only
Arm Type
Active Comparator
Arm Description
0.6 mg/kg MPH, No BMOD
Arm Title
Low Intensity BMOD Only
Arm Type
Active Comparator
Arm Description
Placebo, Low Intensity BMOD
Arm Title
Low Intensity BMOD + Low Dose Medication
Arm Type
Active Comparator
Arm Description
0.15 mg/kg MPH, Low Intensity BMOD
Arm Title
Low Intensity BMOD + Medium Dose Medication
Arm Type
Active Comparator
Arm Description
0.3 mg/kg MPH, Low Intensity BMOD
Arm Title
Low Intensity BMOD + Higher Dose Medication
Arm Type
Active Comparator
Arm Description
0.6 mg/kg MPH, Low Intensity BMOD
Arm Title
High Intensity BMOD Only
Arm Type
Active Comparator
Arm Description
Placebo, High Intensity BMOD
Arm Title
High Intensity BMOD + Low Dose Medication
Arm Type
Active Comparator
Arm Description
0.15 mg/kg MPH, High Intensity BMOD
Arm Title
High Intensity BMOD + Medium Dose Medication
Arm Type
Active Comparator
Arm Description
0.3 mg/kg MPH, High Intensity BMOD
Arm Title
High Intensity BMOD + Higher Dose Medication
Arm Type
Active Comparator
Arm Description
0.6 mg/kg MPH, High Intensity BMOD
Intervention Type
Drug
Intervention Name(s)
Methylphenidate 0.15 mg/kg
Intervention Description
0.15 m/kg/dose immediate-release methylphenidate
Intervention Type
Behavioral
Intervention Name(s)
Low-Intensity BMOD
Intervention Description
Lower-intensity behavioral treatment package.
Intervention Type
Drug
Intervention Name(s)
Methylphenidate 0.3 mg/kg
Intervention Description
0.3 mg/kg/dose immediate-release methylphenidate
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Methylphenidate 0.6 mg/kg
Intervention Description
0.3 mg/kg/dose immediate-release methylphenidate
Intervention Type
Behavioral
Intervention Name(s)
High Intensity BMOD
Intervention Description
Comprehensive high-intensity Summer Treatment Program (STP)
Primary Outcome Measure Information:
Title
Social Behavior-Negative Verbalizations
Description
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.
Time Frame
Daily for 45 days
Title
Classroom Behavior
Description
Daily records of percentage of assigned problems completed by children in a 60-minute classroom period.
Time Frame
Daily for 45 days
Secondary Outcome Measure Information:
Title
Treatment Satisfaction
Description
Parent rating of treatment satisfaction with medication, behavioral treatment, and their combination,on a scale of 1 (bad) to 7 (good).
Time Frame
End of Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William E Pelham, PhD
Organizational Affiliation
Professor, Florida International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida International University Center for Children and Families
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States
Facility Name
Center for Children and Families, University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
24429997
Citation
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.
Results Reference
background
Links:
URL
http://ccf.fiu.edu
Description
Center for Children and Families Home Page

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

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