Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders

Sponsor

John Piacentini (Other)

Overall Status

Completed

CT.gov ID

NCT00675675

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tic Disorder	Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT) Behavioral: Minimal Contact Waitlist	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

TRECC: Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Comprehensive Behavioral Intervention for Tics (CBIT) 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	Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT) Habit Reversal Training plus functional assessment/intervention designed to identify and ameliorate tic triggers (antecedents) and maintaining consequences.
Other: Minimal Contact Waitlist Bimonthly phone check-in to assess illness severity and maximize subject retention	Behavioral: Minimal Contact Waitlist Bimonthly phone check-in to assess clinical status and enhance subject retention

Arm

Intervention/Treatment

Active Comparator: Comprehensive Behavioral Intervention for Tics (CBIT)

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

Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)

Habit Reversal Training plus functional assessment/intervention designed to identify and ameliorate tic triggers (antecedents) and maintaining consequences.

Other: Minimal Contact Waitlist

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

Behavioral: Minimal Contact Waitlist

Bimonthly phone check-in to assess clinical status and enhance subject retention

Outcome Measures

Primary Outcome Measures

Clinical Global Impressions - Improvement [Wks 0, 5, 10]

Secondary Outcome Measures

Yale Global Tic Severity Scale [Wks 0, 5, 10]

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 14 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles	Los Angeles	California	United States	90024

Sponsors and Collaborators

John Piacentini

Investigators

Study Director: John Piacentini, Ph.D., University of California, Los Angeles
Principal Investigator: James McCracken, M.D., University of California, Los Angeles