<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03042507</url>
  </required_header>
  <id_info>
    <org_study_id>1012011424R005</org_study_id>
    <nct_id>NCT03042507</nct_id>
  </id_info>
  <brief_title>Psychosocial Intervention for Young Children With Chronic Tics</brief_title>
  <acronym>CBIT JR</acronym>
  <official_title>Psychosocial Intervention for Young Children With Chronic Tics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Wisconsin, Milwaukee</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Analysis of data from the recently completed NIH Child Comprehensive Behavioral Intervention&#xD;
      for Tics (CBIT) study found a manualized behavioral treatment approach strongly superior to&#xD;
      psychoeducation/supportive therapy for reducing tic severity in 9-16 year-old youths with TS&#xD;
      or other Chronic Tic Disorders. Buoyed by the success of the NIH study, the research group&#xD;
      now seeks to extend and disseminate the CBIT treatment through the systematic adaptation of&#xD;
      the CBIT protocol for use across a broader range of ages and treatment settings.&#xD;
&#xD;
      The goal of the this project is to develop a downward extension of the CBIT therapist guide&#xD;
      and parent workbook for use in 4-8 year old children with chronic tics. The revised CBIT-JR&#xD;
      manual/workbook will be pilot tested in five children at each of the three study sites (UCLA,&#xD;
      UWM, Weill Cornell) in order to provide initial data regarding treatment feasibility and&#xD;
      acceptability as well as our ability to implement the new intervention, along with relevant&#xD;
      quality control procedures, consistently across sites. These pilot data will then be used to&#xD;
      seek R01 support for a larger controlled multisite trial examining the efficacy of CBIT-JR.&#xD;
&#xD;
      Although arguably more complex than a single-site design, we have opted for a multsite study&#xD;
      in order: 1) to take advantage of the established productive collaborative relationship and&#xD;
      collective expertise in childhood tic disorders and psychosocial treatment development across&#xD;
      our three sites, 2) to collect the proposed feasibility data in a much shorter period of time&#xD;
      than otherwise possible, and as noted above 3) to demonstrate the cross-site portability of&#xD;
      the treatment - which will be necessary if we are to obtain subsequent funding for a&#xD;
      larger-scale efficacy trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall aim of the proposed project is to develop and obtain preliminary feasibility and&#xD;
      acceptability data for a family-based behavioral intervention to reduce tic severity and the&#xD;
      negative impact of TS-related symptoms in young children (ages 4-8) with chronic tics and&#xD;
      Tourette syndrome. This intervention entails the use of targeted psychoeducation about tics&#xD;
      and related conditions and a functional analytic protocol designed to identify and correct&#xD;
      environmental influences thought to exacerbate and/or maintain child tic expression. Although&#xD;
      similar to the family-based component used in our recently completed CBITS trial for older&#xD;
      children, an independent body of literature supports the efficacy of functional analysis for&#xD;
      ameliorating a variety of both behaviorally and biologically-driven behaviors. The&#xD;
      investigators will work with an early child interventionist to adapt the current family-based&#xD;
      protocol for younger children. The new manual will then be feasibility tested in anticipation&#xD;
      of a larger externally-funded trial to further develop and evaluate the efficacy of this&#xD;
      intervention.&#xD;
&#xD;
      More specifically, the study aims are to:&#xD;
&#xD;
        1. Adapt the current CBIT Manual for use with the families of 4-8 year old children with&#xD;
           chronic tic disorder. Our revision will be informed by a meeting of the study PI's and&#xD;
           Dr. Mary O'Connor, an early childhood interventionist at UCLA to review our current&#xD;
           family-intervention and other treatment protocols targeting related psychopathology in&#xD;
           young children.&#xD;
&#xD;
        2. Document the feasibility, acceptability, and cross-site portability of the new manual in&#xD;
           a small open trial of 15 youngsters (five each at UCLA, UWM, and Weill Cornell).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">December 29, 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Yale Global Tic Severity Scale (YGTSS).</measure>
    <time_frame>Baseline, week 8</time_frame>
    <description>Change in tic severity from baseline to week 8 as measured by the YGTSS.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Tourette's Syndrome</condition>
  <condition>Tourette's Disorder</condition>
  <condition>Tourette's Disease</condition>
  <condition>Tourette Disorder</condition>
  <condition>Tourette Disease</condition>
  <condition>Tic Disorder, Combined Vocal and Multiple Motor</condition>
  <condition>Multiple Motor and Vocal Tic Disorder, Combined</condition>
  <condition>Gilles de La Tourette's Disease</condition>
  <condition>Gilles de la Tourette Syndrome</condition>
  <condition>Gilles De La Tourette's Syndrome</condition>
  <condition>Combined Vocal and Multiple Motor Tic Disorder</condition>
  <condition>Combined Multiple Motor and Vocal Tic Disorder</condition>
  <condition>Chronic Motor and Vocal Tic Disorder</condition>
  <arm_group>
    <arm_group_label>Open Trial</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This is a non-randomized open trial of a behavioral intervention for young children with tics</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Comprehensive Behavioral Intervention for Tics (CBIT)</intervention_name>
    <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.</description>
    <arm_group_label>Open Trial</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age 4-8&#xD;
&#xD;
          2. presence of motor and/or vocal tics for at least 6 months.&#xD;
&#xD;
          3. tics are of at least moderate clinical severity as evidenced by a Clinical Global&#xD;
             Impressions (CGI) Severity score of 4 or higher (tic symptoms clearly noticeable to&#xD;
             family and occasionally to families and associated with at least some minimal level of&#xD;
             distress and/or interference.&#xD;
&#xD;
          4. free of PDD or other developmental disability&#xD;
&#xD;
          5. IQ estimate of 70 or higher&#xD;
&#xD;
          6. comorbid disorder (e.g., ADHD, OCD, ODD) will be allowed provided that the tic&#xD;
             symptoms are of primary concern to parents and comorbid symptoms are not of sufficient&#xD;
             severity to require immediate treatment other than that provided by the current study.&#xD;
&#xD;
          7. pre-existing stable medication, tic or otherwise, will also be allowed provided the&#xD;
             family agrees to refrain from med changes over the course of the study if at all&#xD;
             possible.&#xD;
&#xD;
          8. sufficient command of the English language to comply with study protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shannon Bennett, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>July 29, 2019</last_update_submitted>
  <last_update_submitted_qc>July 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tourette Syndrome</mesh_term>
    <mesh_term>Tics</mesh_term>
    <mesh_term>Tic Disorders</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03042507
org study id: 1012011424R005
nct id: NCT03042507
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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:

        1. 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.

        2. 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).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Yale Global Tic Severity Scale (YGTSS).
time frame: Baseline, week 8
description: Change in tic severity from baseline to week 8 as measured by the YGTSS.
arm group label: Open Trial
arm group type: Other
description: This is a non-randomized open trial of a behavioral intervention for young children with tics
intervention type: Behavioral
intervention name: Comprehensive Behavioral Intervention for Tics (CBIT)
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.
arm group label: Open Trial
criteria: 
gender: All
minimum age: 4 Years
maximum age: 8 Years
healthy volunteers: No
last name: Shannon Bennett, PhD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
responsible party type: Sponsor
mesh term: Tourette Syndrome
mesh term: Tics
mesh term: Tic Disorders
mesh term: Syndrome
sharing ipd: Yes