Dissemination of Comprehensive Behavioral Intervention for Tics (CBIT) to Occupational Therapists… (NCT02114905) | Clinical Trial Compass
CompletedNot Applicable
Dissemination of Comprehensive Behavioral Intervention for Tics (CBIT) to Occupational Therapists: A Feasibility Study
United States13 participantsStarted 2013-11
Plain-language summary
Comprehensive Behavioral Intervention for Tics (CBIT) is an evidence based intervention for tic disorders. A recent scientific review of research priorities completed by the Tourette Syndrome Association recommended widespread dissemination of CBIT as an important next step in services delivery research. Given early evidence that occupational therapists can deliver CBIT effectively, a dissemination strategy using occupational therapists may improve accessibility to this treatment, at lower cost and with decreased stigma. Thus the goal of this study is to develop and test a training and dissemination model with occupational therapists (OTs) using an expert, multi-disciplinary team at Weill Cornell/New York Presbyterian Hospital (WC/NYPH) and University of Alabama at Birmingham (UAB). The investigators have adapted CBIT, the gold-standard behavioral intervention program for children with tic disorders (Woods et al, 2008a,b), for eventual use in OT programs across the country.
Who can participate
Age range
7 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 7-17
* Presence of motor and/or vocal tics for at least 6 months
* Tics are of at least moderate clinical severity as evidenced by a Clinical Global Impressions Severity (CGI-S) 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.
* IQ estimate of 70 or higher
* 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.
* 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.
* Sufficient command of the English language to comply with study protocol.
Exclusion Criteria:
* Free of PDD or other developmental disability
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment Acceptability Questionnaire
Timeframe: One year
Trial details
NCT IDNCT02114905
SponsorWeill Medical College of Cornell University