Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders

John Piacentini

Status: Completed

Conditions: Tic Disorder

Treatments: Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT); Behavioral: Minimal Contact Waitlist

Study type: Interventional

Funder types: Other

Identifiers

NCT00675675

P50MH077248 (U.S. NIH Grant/Contract)

UCLAP500772484

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 9 to 14 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups

Comprehensive Behavioral Intervention for Tics (CBIT)

Active Comparator group

Description:

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

Treatment:

Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)

Minimal Contact Waitlist

Other group

Description:

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

Treatment:

Behavioral: Minimal Contact Waitlist