Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders

Tic Disorder Clinical Trial

Official title:

TRECC: Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675675
• Other study ID #: UCLAP500772484
• Secondary ID: P50MH077248
• Status: Completed
• Phase: N/A
• First received: May 7, 2008
• Last updated: August 19, 2015
• Start date: July 2007
• Est. completion date: December 2011

Study information

• Verified date: August 2015
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 14 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Tic Disorder
• Tic Disorders
• Tics

Intervention

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 clinical status and enhance subject retention

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
John Piacentini

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impressions - Improvement		Wks 0, 5, 10	No
Secondary	Yale Global Tic Severity Scale		Wks 0, 5, 10	No

External Links

•   UCLA Child OCD, Anxiety, and Tic Disorders Program