Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Piacentini, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00675675
First received: May 7, 2008
Last updated: August 19, 2015
Last verified: August 2015
  Purpose

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 Intervention
Tic Disorder
Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)
Behavioral: Minimal Contact Waitlist

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: TRECC: Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Clinical Global Impressions - Improvement [ Time Frame: Wks 0, 5, 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Yale Global Tic Severity Scale [ Time Frame: Wks 0, 5, 10 ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: July 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675675

Locations
United States, California
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
  More Information

Additional Information:
No publications provided

Responsible Party: John Piacentini, Professor in Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00675675     History of Changes
Other Study ID Numbers: UCLAP500772484, P50 MH077248
Study First Received: May 7, 2008
Last Updated: August 19, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Tourette Syndrome
Chronic Tic Disorder
Tics
Behavior Therapy
Habit Reversal Training
Child
Adolescent
Neuroimaging

Additional relevant MeSH terms:
Tic Disorders
Tics
Central Nervous System Diseases
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Movement Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2015