Ignite Creation Date:
2024-05-06 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05050734
Status:
UNKNOWN
Last Update Posted:
2021-10-08
First Post:
2021-09-03
Brief Title:
Online-Delivered Comprehensive Behavioral Intervention for Tics-Enhanced CBIT-E
Sponsor:
Marquette University
Organization:
Marquette University
Study Overview
Official Title:
A Randomized Waitlist-Controlled Pilot Trial of Online-Delivered Comprehensive Behavioral Intervention for Tics-Enhanced CBIT-E
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
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 pilot trial is to examine the preliminary efficacy of online-delivered Comprehensive Behavioral Intervention for Tics - Enhanced CBIT-E In the study 30 children with persistent tic disorders PTDs will be recruited via information provided to patients of the Marquette University MU Tic Disorders Specialty Clinic TDSC and information conveyed via local medical health professionals with the goal of randomizing 10 participants to each group For those randomized to CBIT-E treatment will be administered according to the standard CBIT manual but there will be two modifications CBIT typically consists of the implementation of strategies to help manage the environment related to tics and the implementation of an exercise to engage in when an individual feels the urge to tic CBIT-E will include these same techniques plus additional in-session and out of session practice of the exercises called competing responses that individuals use when they feel the urge to tic Treatment will be delivered over Microsoft Teams which is a secure video conferencing system The therapist will administer treatment from a private room in the Marquette University Tic Disorder Specialty Clinic while the parent and child will be at their home Treatment will include a screening visit baseline assessment 11 weeks 9 sessions of CBIT-E a post treatment assessment and a three-month follow up assessment Further starting after session 3 there will be four 15-minute practice periods scheduled each week between sessions During these practice periods the child and therapist will meet over Microsoft Teams and the therapist will administer an enhanced reward task
Children randomized to the waitlist control WLC will not receive treatment during the 11-week period Instead they will be placed on a waitlist to receive standard CBIT following the end of the study period Participants in this group will complete a screening visit baseline assessment and a final assessment which will occur approximately 11 weeks after baseline
Children randomized to the waitlist control WLC will not receive treatment during the 11-week period Instead they will be placed on a waitlist to receive standard CBIT following the end of the study period Participants in this group will complete a screening visit baseline assessment and a final assessment which will occur approximately 11 weeks after baseline
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None