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

Not Applicable

Completed

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

• Registration Number: NCT00050622
• Lead Sponsor: Florida International University

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.

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2002-12-16
• Study First Submitted QC: 2002-12-16
• Study First Posted: 2002-12-17
• Primary Completion: 2004-08
• Study Completion: 2005-06
• Results First Submitted: 2016-05-31
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-08
• Last Update Submitted: 2016-08-08
• Results First Posted: 2016-09-30
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Intensity BMOD + Higher Dose Medication	Methylphenidate 0.6 mg/kg	0.6 mg/kg MPH, High Intensity BMOD
High Intensity BMOD + Low Dose Medication	Methylphenidate 0.15 mg/kg	0.15 mg/kg MPH, High Intensity BMOD
Higher Dose Medication Only	Methylphenidate 0.6 mg/kg	0.6 mg/kg MPH, No BMOD
Low Intensity BMOD Only	Low-Intensity BMOD	Placebo, Low Intensity BMOD
No Treatment	Placebo	No Medication, No Behavior Modification (BMOD)
Low Dose Medication Only	Methylphenidate 0.15 mg/kg	0.15 mg/kg methylphenidate (MPH), No BMOD
Medium Dose Medication Only	Methylphenidate 0.3 mg/kg	0.3 mg/kg MPH, No BMOD
Low Intensity BMOD Only	Placebo	Placebo, Low Intensity BMOD
Low Intensity BMOD + Low Dose Medication	Methylphenidate 0.15 mg/kg	0.15 mg/kg MPH, Low Intensity BMOD
Low Intensity BMOD + Low Dose Medication	Low-Intensity BMOD	0.15 mg/kg MPH, Low Intensity BMOD
Low Intensity BMOD + Medium Dose Medication	Low-Intensity BMOD	0.3 mg/kg MPH, Low Intensity BMOD
High Intensity BMOD + Medium Dose Medication	High Intensity BMOD	0.3 mg/kg MPH, High Intensity BMOD
Low Intensity BMOD + Medium Dose Medication	Methylphenidate 0.3 mg/kg	0.3 mg/kg MPH, Low Intensity BMOD
Low Intensity BMOD + Higher Dose Medication	Low-Intensity BMOD	0.6 mg/kg MPH, Low Intensity BMOD
Low Intensity BMOD + Higher Dose Medication	Methylphenidate 0.6 mg/kg	0.6 mg/kg MPH, Low Intensity BMOD
High Intensity BMOD Only	High Intensity BMOD	Placebo, High Intensity BMOD
High Intensity BMOD + Low Dose Medication	High Intensity BMOD	0.15 mg/kg MPH, High Intensity BMOD
High Intensity BMOD + Medium Dose Medication	Methylphenidate 0.3 mg/kg	0.3 mg/kg MPH, High Intensity BMOD
High Intensity BMOD + Higher Dose Medication	High Intensity BMOD	0.6 mg/kg MPH, High Intensity BMOD

Primary Outcome Measures

Name	Time	Method
Social Behavior-Negative Verbalizations	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.
Classroom Behavior	Daily for 45 days	Daily records of percentage of assigned problems completed by children in a 60-minute classroom period.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Florida International University Center for Children and Families; 🇺🇸 Miami, Florida, United States

Center for Children and Families, University at Buffalo; 🇺🇸 Buffalo, New York, United States