Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders

TRECC: Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders

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.

Study Overview

• Status: Completed
• Conditions: Tic Disorder
• Intervention / Treatment: Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT); Behavioral: Minimal Contact Waitlist

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • University of California, Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical Global Impressions - Improvement	Wks 0, 5, 10

Secondary Outcome Measures

Outcome Measure	Time Frame
Yale Global Tic Severity Scale	Wks 0, 5, 10

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: May 7, 2008
• First Submitted That Met QC Criteria: May 9, 2008
• First Posted (ESTIMATE): May 12, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 21, 2015
• Last Update Submitted That Met QC Criteria: August 19, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Adolescent; Child; Neuroimaging; Tourette Syndrome; Behavior Therapy; Tics; Habit Reversal Training; Chronic Tic Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Neurodevelopmental Disorders; Disease; Tic Disorders; Tics
• Other Study ID Numbers: UCLAP500772484; P50MH077248 (NIH)