Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050622
Status:
COMPLETED
Last Update Posted:
2016-09-30
First Post:
2002-12-16
Brief Title:
Behavioral Treatment Drug Treatment and Combined Treatment for Attention Deficit Hyperactivity Disorder ADHD
Sponsor:
Florida International University
Organization:
Florida International University
Study Overview
Official Title:
ADHD Treatment Comparative and Combined Dosage Effects
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 015 mgkg methylphenidate 03 mgkg methylphenidate or 06 mgkg 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR CT-CT | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH062946 |
| R01MH062946 | NIH | None | None |