Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders

NCT ID: NCT00675675

Last Updated: 2015-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-12-31

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.

Conditions

Tic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Comprehensive Behavioral Intervention for Tics (CBIT)

Intervention Type: BEHAVIORAL

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

Group Type: OTHER

Minimal Contact Waitlist

Intervention Type: BEHAVIORAL

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

Interventions

Comprehensive Behavioral Intervention for Tics (CBIT)

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

Intervention Type: BEHAVIORAL

Minimal Contact Waitlist

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

John Piacentini

OTHER

Sponsor Role: lead

Responsible Party

John Piacentini

Professor in Residence

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John Piacentini, Ph.D.

Role: STUDY_DIRECTOR

University of California, Los Angeles

James McCracken, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

P50MH077248

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UCLAP500772484

Identifier Type: -

Identifier Source: org_study_id