NCT02114905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

1.7 years

First QC Date

February 6, 2014

Last Update Submit

September 18, 2019

Conditions

Keywords

Tourette'sTic DisorderCBITDisseminationOccupational Therapist

Outcome Measures

Primary Outcomes (1)

  • 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.

    One year

Study Arms (1)

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.

Behavioral: OTs Trained and Deliver CBIT

Interventions

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.

Also known as: CBIT
OTs Trained and Deliver CBIT

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Free of PDD or other developmental disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Tourette SyndromeTic Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental Disorders

Study Officials

  • Shannon Bennett, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR
  • Jan Rowe, OT

    University of Alabama at Birmingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2014

First Posted

April 15, 2014

Study Start

November 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 20, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations