Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00233129
Status:
COMPLETED
Last Update Posted:
2013-09-24
First Post:
2005-10-03
Brief Title:
Improving Executive Functions After Traumatic Brain Injury TBI A Clinical Trial of the Executive Plus Program
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Improving Executive Functions After TBI A Randomized Clinical Trial of the Executive Plus Program
Status:
COMPLETED
Status Verified Date:
2013-09
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:
This is a randomized clinical trial which compares a standard day treatment program for individuals with TBI with the Executive Plus program the latter emphasizes training of attention emotional self-regulation and problem solving The goal of the Executive Plus program is to maximize executive functioning as well as the long-term outcomes of community participation and satisfaction with daily life
Detailed Description:
This is a randomized clinical trial comparing two approaches to post-TBI comprehensive day treatment Executive Plus offers systematic treatment of post-TBI executive function deficits through a focus on problem solving and emotional self-regulation as well as systematic treatment of post-TBI attention deficits It relies on modular contextual and embedded approaches to treatment It will be compared to Mount Sinais currently operating day treatment program The 26-week programs will run concurrently and potential participants will be randomly assigned to Executive Plus or the standard program using rolling admissions Program staffs will be separate Outcomes will be assessed using measures that focus on functioning within cognitive domains across domains and in everyday life and that assess long-term outcomes Detailed manuals will be developed to guide the implementation of each programs operation
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 |
|---|---|---|---|
| H133B040033 | None | None | None |