Tourette DisorderNCT02114905
Dissemination of Comprehensive Behavioral Intervention for Tics (CBIT) to Occupational Therapists: A Feasibility Study
A study testing OTs Trained and Deliver CBIT in people with Tourette Disorder and Chronic Tic Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Tourette Disorder, Chronic Tic Disorder
- What is being tested?
- OTs Trained and Deliver CBIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Free of PDD or other developmental disability
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
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.
Read the 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.
- Conditions
- Tourette Disorder, Chronic Tic Disorder
- Being tested
- OTs Trained and Deliver CBIT
- Keywords
- Tourette's, Tic Disorder, CBIT, Dissemination, Occupational Therapist
- Medical subject headings
- Tourette Syndrome, Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTs Trained and Deliver CBITBehavioural
Also called CBIT
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.
| Study group | Role | What they receive |
|---|---|---|
| OTs Trained and Deliver CBIT | Experimental | 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. Receives: Behavioral: OTs Trained and Deliver CBIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startNov 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette DisorderStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Shannon Bennett, PhD, Principal investigator, Weill Medical College of Cornell UniversityJan Rowe, OT, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114905
- Sponsor's protocol ID
- 1208012814
- Status last verified
- Sep 2019
- First submitted
- 6 Feb 2014
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination of Comprehensive Behavioral Intervention for Tics (CBIT) to Occupational Therapists: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02114905
- Acronym / sponsor ID
- 1208012814
- Conditions
- Tourette Disorder, Chronic Tic Disorder
- Keywords
- Tourette's, Tic Disorder, CBIT, Dissemination, Occupational Therapist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- Nov 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OTs Trained and Deliver CBIT | Experimental | Behavioral: OTs Trained and Deliver CBITCBIT 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. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- Free of PDD or other developmental disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTs Trained and Deliver CBITAlso: CBITCBIT 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. | Behavioural | OTs Trained and Deliver CBIT |
Primary outcome
Treatment Acceptability Questionnaire
Time frame: One year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Tourette Disorder
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
Tourette Syndrome, Chronic Tic Disorder
Recruiting
Deep Brain Stimulation Therapy in Movement Disorders
Parkinson's Disease
Recruiting
Exploring the Role of Neuroactive Steroids in Tourette Syndrome
Tourette Syndrome in Children
Active, not recruiting
Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression
Tourette Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Bennett, PhD principal investigator
Weill Medical College of Cornell University
Jan Rowe, OT study chair
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTs Trained and Deliver CBIT in people with Tourette Disorder and Chronic Tic Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Acceptability Questionnaire (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.