Back to resultsDissemination of Comprehensive Behavioral Intervention for Tics (CBIT) to Occupational Therapists: A Feasibility Study
Primary Purpose
Tourette Disorder, Chronic Tic Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OTs Trained and Deliver CBIT
Sponsored by
About this trial
This is an interventional treatment trial for Tourette Disorder focused on measuring Tourette's, Tic Disorder, CBIT, Dissemination, Occupational Therapist
Eligibility Criteria
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
Sites / Locations
- Weill Cornell Medical College
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OTs Trained and Deliver CBIT
Arm Description
CBIT certified clinicians will train OTs in delivering CBIT to affected youth. OTs will be supervised in the practice of CBIT with youth in the New York City and Birmingham areas. Pre- and post-treatment assessment measures will be collected from 16 families (8 from each site) to evaluate intervention acceptability, feasibility, and fidelity. Patient and parent satisfaction of CBIT-OT will also be documented.
Outcomes
Primary Outcome Measures
Treatment Acceptability Questionnaire
OT's will fill out a questionnaire at the completion of the study regarding their assessment of the training module, training materials, and their comfortability and confidence delivering CBIT to children.
Secondary Outcome Measures
Full Information
NCT ID
NCT02114905
First Posted
February 6, 2014
Last Updated
September 18, 2019
Sponsor
Weill Medical College of Cornell University
Collaborators
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT02114905
Brief Title
Dissemination of Comprehensive Behavioral Intervention for Tics (CBIT) to Occupational Therapists: A Feasibility Study
Official Title
Dissemination of Comprehensive Behavioral Intervention for Tics (CBIT) to Occupational Therapists: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
CBIT training materials designed by the study team have been used to train occupational therapists (OTs) at WC/NYPH and UAB to deliver CBIT, and data has been collected to measure training acceptability.
OTs will be supervised in the practice of CBIT with youth in the New York City and Birmingham areas. Pre- and post-treatment assessment measures will be collected from 16 families (8 from each site) to evaluate intervention acceptability, feasibility, and fidelity. Patient and parent satisfaction of CBIT-OT will also be documented. The investigators will look within subjects to ascertain change in reported tic severity.
This study is designed to determine the feasibility and acceptability of treatment, feasibility of research design, as well as demonstrate the ability to disseminate the study protocol to a new care discipline in methodologically rigorous fashion across multiple sites.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Disorder, Chronic Tic Disorder
Keywords
Tourette's, Tic Disorder, CBIT, Dissemination, Occupational Therapist
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OTs Trained and Deliver CBIT
Arm Type
Experimental
Arm Description
CBIT certified clinicians will train OTs in delivering CBIT to affected youth. OTs will be supervised in the practice of CBIT with youth in the New York City and Birmingham areas. Pre- and post-treatment assessment measures will be collected from 16 families (8 from each site) to evaluate intervention acceptability, feasibility, and fidelity. Patient and parent satisfaction of CBIT-OT will also be documented.
Intervention Type
Behavioral
Intervention Name(s)
OTs Trained and Deliver CBIT
Other Intervention Name(s)
CBIT
Intervention Description
CBIT is a highly structured therapy that typically takes place on a weekly basis. The patient is taught to perform a specific behavior that makes the tic more difficult to do, as soon as the tic or urge appears. This "competing response" helps to reduce, and in some cases, even eliminate the tic. The functional intervention (FI), is based on the fact that certain situations or reactions to tics can make them worse than they might otherwise be. The goal of FI is to identify these situations and have the patient and family attempt to change them so the tics aren't made worse unnecessarily.
Primary Outcome Measure Information:
Title
Treatment Acceptability Questionnaire
Description
OT's will fill out a questionnaire at the completion of the study regarding their assessment of the training module, training materials, and their comfortability and confidence delivering CBIT to children.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Bennett, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Rowe, OT
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dissemination of Comprehensive Behavioral Intervention for Tics (CBIT) to Occupational Therapists: A Feasibility Study
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