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Psychosocial Intervention for Young Children With Chronic Tics (CBIT JR)

Primary Purpose

Tourette's Syndrome, Tourette's Disorder, Tourette's Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Comprehensive Behavioral Intervention for Tics (CBIT)
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette's Syndrome

Eligibility Criteria

4 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Open Trial

    Arm Description

    This is a non-randomized open trial of a behavioral intervention for young children with tics

    Outcomes

    Primary Outcome Measures

    Yale Global Tic Severity Scale (YGTSS).
    Change in tic severity from baseline to week 8 as measured by the YGTSS.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 27, 2017
    Last Updated
    July 29, 2019
    Sponsor
    Weill Medical College of Cornell University
    Collaborators
    University of California, Los Angeles, University of Wisconsin, Milwaukee
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03042507
    Brief Title
    Psychosocial Intervention for Young Children With Chronic Tics
    Acronym
    CBIT JR
    Official Title
    Psychosocial Intervention for Young Children With Chronic Tics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 20, 2012 (Actual)
    Primary Completion Date
    December 29, 2012 (Actual)
    Study Completion Date
    February 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Weill Medical College of Cornell University
    Collaborators
    University of California, Los Angeles, University of Wisconsin, Milwaukee

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    The overall aim of the proposed project is to develop and obtain preliminary feasibility and acceptability data for a family-based behavioral intervention to reduce tic severity and the negative impact of TS-related symptoms in young children (ages 4-8) with chronic tics and Tourette syndrome. This intervention entails the use of targeted psychoeducation about tics and related conditions and a functional analytic protocol designed to identify and correct environmental influences thought to exacerbate and/or maintain child tic expression. Although similar to the family-based component used in our recently completed CBITS trial for older children, an independent body of literature supports the efficacy of functional analysis for ameliorating a variety of both behaviorally and biologically-driven behaviors. The investigators will work with an early child interventionist to adapt the current family-based protocol for younger children. The new manual will then be feasibility tested in anticipation of a larger externally-funded trial to further develop and evaluate the efficacy of this intervention. More specifically, the study aims are to: Adapt the current CBIT Manual for use with the families of 4-8 year old children with chronic tic disorder. Our revision will be informed by a meeting of the study PI's and Dr. Mary O'Connor, an early childhood interventionist at UCLA to review our current family-intervention and other treatment protocols targeting related psychopathology in young children. Document the feasibility, acceptability, and cross-site portability of the new manual in a small open trial of 15 youngsters (five each at UCLA, UWM, and Weill Cornell).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tourette's Syndrome, Tourette's Disorder, Tourette's Disease, Tourette Disorder, Tourette Disease, Tic Disorder, Combined Vocal and Multiple Motor, Multiple Motor and Vocal Tic Disorder, Combined, Gilles de La Tourette's Disease, Gilles de la Tourette Syndrome, Gilles De La Tourette's Syndrome, Combined Vocal and Multiple Motor Tic Disorder, Combined Multiple Motor and Vocal Tic Disorder, Chronic Motor and Vocal Tic Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Open Trial
    Arm Type
    Other
    Arm Description
    This is a non-randomized open trial of a behavioral intervention for young children with tics
    Intervention Type
    Behavioral
    Intervention Name(s)
    Comprehensive Behavioral Intervention for Tics (CBIT)
    Intervention Description
    The existing CBIT protocol includes a functional assessment procedure designed to identify relevant contextual variables (both antecedent and consequent) impacting tic expression and guide the development of an individualized behavioral program to neutralize these contextual influences in the service of tic reduction and psychoeducational component. Given the central role that negative social reactions typically play in tic exacerbation and maintenance, psychoeducation about tics is systematically provided to parents, siblings, and other caretakers and prominent individuals in the child's life. The other primary CBIT component, Habit Reversal Training (HRT), is used to weaken or eliminate the negative reinforcement cycle created by tic-contingent reduction in premonitory urge.
    Primary Outcome Measure Information:
    Title
    Yale Global Tic Severity Scale (YGTSS).
    Description
    Change in tic severity from baseline to week 8 as measured by the YGTSS.
    Time Frame
    Baseline, week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age 4-8 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 (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. free of PDD or other developmental disability 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: -
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Psychosocial Intervention for Young Children With Chronic Tics

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