Psychosocial Intervention for Young Children With Chronic Tics

NCT03042507 | Completed DMC

• 1 other identifier: 1012011424R005
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

Analysis of data from the recently completed NIH Child Comprehensive Behavioral Intervention for Tics (CBIT) study found a manualized behavioral treatment approach strongly superior to psychoeducation/supportive therapy for reducing tic severity in 9-16 year-old youths with TS or other Chronic Tic Disorders. Buoyed by the success of the NIH study, the research group now seeks to extend and disseminate the CBIT treatment through the systematic adaptation of the CBIT protocol for use across a broader range of ages and treatment settings. The goal of the this project is to develop a downward extension of the CBIT therapist guide and parent workbook for use in 4-8 year old children with chronic tics. The revised CBIT-JR manual/workbook will be pilot tested in five children at each of the three study sites (UCLA, UWM, Weill Cornell) in order to provide initial data regarding treatment feasibility and acceptability as well as our ability to implement the new intervention, along with relevant quality control procedures, consistently across sites. These pilot data will then be used to seek R01 support for a larger controlled multisite trial examining the efficacy of CBIT-JR. Although arguably more complex than a single-site design, we have opted for a multsite study in order: 1) to take advantage of the established productive collaborative relationship and collective expertise in childhood tic disorders and psychosocial treatment development across our three sites, 2) to collect the proposed feasibility data in a much shorter period of time than otherwise possible, and as noted above 3) to demonstrate the cross-site portability of the treatment - which will be necessary if we are to obtain subsequent funding for a larger-scale efficacy trial.

Conditions

Tic Disorder, Combined Vocal and Multiple Motor; Tourette's Syndrome; Tourette's Disorder; Tourette's Disease; Tourette Disorder; Tourette Disease; Multiple Motor and Vocal Tic Disorder, Combined; Gilles de La Tourette's Disease; Gilles de la Tourette Syndrome; Gilles De La Tourette's Syndrome; Combined Vocal and Multiple Motor Tic Disorder; Combined Multiple Motor and Vocal Tic Disorder; Chronic Motor and Vocal Tic Disorder

Outcome Measures

Primary Outcomes (1)

• Yale Global Tic Severity Scale (YGTSS).

  Change in tic severity from baseline to week 8 as measured by the YGTSS.

  Baseline, week 8

Study Arms (1)

Open Trial

OTHER

This is a non-randomized open trial of a behavioral intervention for young children with tics

Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)

Interventions

Comprehensive Behavioral Intervention for Tics (CBIT) BEHAVIORAL

The existing CBIT protocol includes a functional assessment procedure designed to identify relevant contextual variables (both antecedent and consequent) impacting tic expression and guide the development of an individualized behavioral program to neutralize these contextual influences in the service of tic reduction and psychoeducational component. Given the central role that negative social reactions typically play in tic exacerbation and maintenance, psychoeducation about tics is systematically provided to parents, siblings, and other caretakers and prominent individuals in the child's life. The other primary CBIT component, Habit Reversal Training (HRT), is used to weaken or eliminate the negative reinforcement cycle created by tic-contingent reduction in premonitory urge.

Open Trial

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age 4-8
• presence of motor and/or vocal tics for at least 6 months.
• tics are of at least moderate clinical severity as evidenced by a Clinical Global Impressions (CGI) Severity score of 4 or higher (tic symptoms clearly noticeable to family and occasionally to families and associated with at least some minimal level of distress and/or interference.
• free of PDD or other developmental disability
• IQ estimate of 70 or higher
• comorbid disorder (e.g., ADHD, OCD, ODD) will be allowed provided that the tic symptoms are of primary concern to parents and comorbid symptoms are not of sufficient severity to require immediate treatment other than that provided by the current study.
• pre-existing stable medication, tic or otherwise, will also be allowed provided the family agrees to refrain from med changes over the course of the study if at all possible.
• sufficient command of the English language to comply with study protocol.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• University of California, Los Angeles: collaborator
• University of Wisconsin, Milwaukee: collaborator

MeSH Terms

Conditions

Tourette Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Shannon Bennett, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: February 3, 2017
• Study Start: January 20, 2012
• Primary Completion: December 29, 2012
• Study Completion: February 1, 2013
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share