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Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders

Primary Purpose

Tic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Behavioral Intervention for Tics (CBIT)
Minimal Contact Waitlist
Sponsored by
John Piacentini
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tic Disorder focused on measuring Tourette Syndrome, Chronic Tic Disorder, Tics, Behavior Therapy, Habit Reversal Training, Child, Adolescent, Neuroimaging

Eligibility Criteria

9 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • DSM-IV diagnostic criteria for CTD (CMVT or TS)
  • Clinical Global Impressions - Severity Score > 3 (moderately ill or worse)
  • YGTSS Total Score > 14 (or Total Score > 10 if CTD with motor tics only)
  • Unmedicated or on stable psychotropic medication for at least 6 weeks prior to study entry, with no planned changes for duration of study participation
  • Child is fluent English speaker
  • Parental Informed Consent and Child Informed Assent.

Exclusion Criteria:

  • Total YGTSS Score>35 (Cases above this threshold otherwise eligible will be reviewed by Clinical Caseness Panel for potential study participation)
  • IQ < 80 on the Wechsler Abbreviated Scale of Intelligence (WASI)
  • Problematic Substance Use or DSM-IV Conduct Disorder in past 3 months
  • Lifetime DSM-IV diagnosis of PDD, Mania, or Psychotic Disorder
  • Any serious psychiatric, psychosocial, or neurological condition requiring immediate treatment other than that provided in the current study
  • Previous treatment with four or more sessions of HRT for tics
  • Contraindication to fMRI scan

Sites / Locations

  • University of California, Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Comprehensive Behavioral Intervention for Tics (CBIT)

Minimal Contact Waitlist

Arm Description

Habit Reversal Training (HRT) plus functional assessment/intervention designed to identify and ameliorate environmental triggers for and consequences to tics that might serve to maintain and/or generalize these symptoms

Bimonthly phone check-in to assess illness severity and maximize subject retention

Outcomes

Primary Outcome Measures

Clinical Global Impressions - Improvement

Secondary Outcome Measures

Yale Global Tic Severity Scale

Full Information

First Posted
May 7, 2008
Last Updated
August 19, 2015
Sponsor
John Piacentini
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1. Study Identification

Unique Protocol Identification Number
NCT00675675
Brief Title
Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders
Official Title
TRECC: Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John Piacentini

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study aims to clarify the functional anatomy of key brain circuits associated with cognitive control in children and adolescents with chronic tic disorders (CTD) and to compare and contrast hypothesized mechanisms related to increased tic control associated with Habit Reversal Training, a behavioral treatment that been previously shown to be effective in treating CTD. We also seek to better understand the relationship between fMRI and quantitative EEG in relevant brain circuits with the hope of establishing EEG as a valid and cost-effective marker of treatment responsiveness. A total of 25 subjects will be randomized to 10 weeks of Habit Reversal Training (HRT), a behavioral treatment, and 25 to 10 weeks of minimal-contact waitlist. Treatment responders will be re-assessed at three months. Waitlist nonresponders will be provided with 10 weeks of HRT. Study assessments, including a neurocognitive battery and quantitative EEG will be administered at baseline, Wk 5, Wk 10, and 3-month follow-up. Neuroimaging (fMRI) will be conducted at baseline and Wk 10.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tic Disorder
Keywords
Tourette Syndrome, Chronic Tic Disorder, Tics, Behavior Therapy, Habit Reversal Training, Child, Adolescent, Neuroimaging

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comprehensive Behavioral Intervention for Tics (CBIT)
Arm Type
Active Comparator
Arm Description
Habit Reversal Training (HRT) plus functional assessment/intervention designed to identify and ameliorate environmental triggers for and consequences to tics that might serve to maintain and/or generalize these symptoms
Arm Title
Minimal Contact Waitlist
Arm Type
Other
Arm Description
Bimonthly phone check-in to assess illness severity and maximize subject retention
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Behavioral Intervention for Tics (CBIT)
Intervention Description
Habit Reversal Training plus functional assessment/intervention designed to identify and ameliorate tic triggers (antecedents) and maintaining consequences.
Intervention Type
Behavioral
Intervention Name(s)
Minimal Contact Waitlist
Intervention Description
Bimonthly phone check-in to assess clinical status and enhance subject retention
Primary Outcome Measure Information:
Title
Clinical Global Impressions - Improvement
Time Frame
Wks 0, 5, 10
Secondary Outcome Measure Information:
Title
Yale Global Tic Severity Scale
Time Frame
Wks 0, 5, 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-IV diagnostic criteria for CTD (CMVT or TS) Clinical Global Impressions - Severity Score > 3 (moderately ill or worse) YGTSS Total Score > 14 (or Total Score > 10 if CTD with motor tics only) Unmedicated or on stable psychotropic medication for at least 6 weeks prior to study entry, with no planned changes for duration of study participation Child is fluent English speaker Parental Informed Consent and Child Informed Assent. Exclusion Criteria: Total YGTSS Score>35 (Cases above this threshold otherwise eligible will be reviewed by Clinical Caseness Panel for potential study participation) IQ < 80 on the Wechsler Abbreviated Scale of Intelligence (WASI) Problematic Substance Use or DSM-IV Conduct Disorder in past 3 months Lifetime DSM-IV diagnosis of PDD, Mania, or Psychotic Disorder Any serious psychiatric, psychosocial, or neurological condition requiring immediate treatment other than that provided in the current study Previous treatment with four or more sessions of HRT for tics Contraindication to fMRI scan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Piacentini, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
James McCracken, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States

12. IPD Sharing Statement

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Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders

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