Psychosocial Intervention for Young Children With Chronic Tics

NCT03042507 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-07-30

No results posted yet for this study

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

  • Tourette's Syndrome
  • Tourette's Disorder
  • Tourette's Disease
  • Tourette Disorder
  • Tourette Disease
  • Tic Disorder, Combined Vocal and Multiple Motor
  • 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

Interventions

BEHAVIORAL

Comprehensive Behavioral Intervention for Tics (CBIT)

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.

Sponsors & Collaborators

Principal Investigators

  • Shannon Bennett, PhD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-20
Primary Completion
2012-12-29
Completion
2013-02-28

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03042507 on ClinicalTrials.gov