Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders

NCT00675675 | Completed DMC

• 2 other identifiers: UCLAP500772484P50MH077248
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Keywords

Tourette Syndrome; Chronic Tic Disorder; Tics; Behavior Therapy; Habit Reversal Training; Child; Adolescent; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impressions - Improvement

  Wks 0, 5, 10

Secondary Outcomes (1)

• Yale Global Tic Severity Scale

  Wks 0, 5, 10

Study Arms (2)

Comprehensive Behavioral Intervention for Tics (CBIT)

ACTIVE COMPARATOR

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)

Minimal Contact Waitlist

OTHER

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

Behavioral: Minimal Contact Waitlist

Interventions

Comprehensive Behavioral Intervention for Tics (CBIT) BEHAVIORAL

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

Comprehensive Behavioral Intervention for Tics (CBIT)

Minimal Contact Waitlist BEHAVIORAL

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

Minimal Contact Waitlist

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• John Piacentini: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Tic Disorders; Tourette Syndrome; Tics

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders; Basal Ganglia Diseases; Brain Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John Piacentini, Ph.D.

  University of California, Los Angeles

  STUDY DIRECTOR

• James McCracken, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in Residence

Study Record Dates

• First Submitted: May 7, 2008
• First Posted: May 12, 2008
• Study Start: July 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 21, 2015

Record last verified: 2015-08

Locations

US (1)