Tourette's Syndrome Clinical Trial
— CBIT JROfficial title:
Psychosocial Intervention for Young Children With Chronic Tics
Verified date | July 2019 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Analysis of data from the recently completed NIH Child Comprehensive Behavioral Intervention
for Tics (CBIT) study found a manualized behavioral treatment approach strongly superior to
psychoeducation/supportive therapy for reducing tic severity in 9-16 year-old youths with TS
or other Chronic Tic Disorders. Buoyed by the success of the NIH study, the research group
now seeks to extend and disseminate the CBIT treatment through the systematic adaptation of
the CBIT protocol for use across a broader range of ages and treatment settings.
The goal of the this project is to develop a downward extension of the CBIT therapist guide
and parent workbook for use in 4-8 year old children with chronic tics. The revised CBIT-JR
manual/workbook will be pilot tested in five children at each of the three study sites (UCLA,
UWM, Weill Cornell) in order to provide initial data regarding treatment feasibility and
acceptability as well as our ability to implement the new intervention, along with relevant
quality control procedures, consistently across sites. These pilot data will then be used to
seek R01 support for a larger controlled multisite trial examining the efficacy of CBIT-JR.
Although arguably more complex than a single-site design, we have opted for a multsite study
in order: 1) to take advantage of the established productive collaborative relationship and
collective expertise in childhood tic disorders and psychosocial treatment development across
our three sites, 2) to collect the proposed feasibility data in a much shorter period of time
than otherwise possible, and as noted above 3) to demonstrate the cross-site portability of
the treatment - which will be necessary if we are to obtain subsequent funding for a
larger-scale efficacy trial.
Status | Completed |
Enrollment | 15 |
Est. completion date | February 2013 |
Est. primary completion date | December 29, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 8 Years |
Eligibility |
Inclusion Criteria: 1. age 4-8 2. presence of motor and/or vocal tics for at least 6 months. 3. tics are of at least moderate clinical severity as evidenced by a Clinical Global Impressions (CGI) Severity score of 4 or higher (tic symptoms clearly noticeable to family and occasionally to families and associated with at least some minimal level of distress and/or interference. 4. free of PDD or other developmental disability 5. IQ estimate of 70 or higher 6. comorbid disorder (e.g., ADHD, OCD, ODD) will be allowed provided that the tic symptoms are of primary concern to parents and comorbid symptoms are not of sufficient severity to require immediate treatment other than that provided by the current study. 7. pre-existing stable medication, tic or otherwise, will also be allowed provided the family agrees to refrain from med changes over the course of the study if at all possible. 8. sufficient command of the English language to comply with study protocol. Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | University of California, Los Angeles, University of Wisconsin, Milwaukee |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Yale Global Tic Severity Scale (YGTSS). | Change in tic severity from baseline to week 8 as measured by the YGTSS. | Baseline, week 8 |
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