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Clinical Trials/NCT04087616
NCT04087616
Unknown
N/A

Internet-based -Guided Self-help Intervention for Children With Chronic Tics Syndrome or Tourette Syndrome: Comprehensive Behavioral Intervention for Tics (CBIT) Versus Waiting List: Reduction of Tic Severity and Quality of Life Measures

Tel Aviv Medical Center2 sites in 1 country40 target enrollmentJuly 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Tourette Syndrome in Children
Sponsor
Tel Aviv Medical Center
Enrollment
40
Locations
2
Primary Endpoint
Yale Global Tic Severity Scale (YGTSS)
Last Updated
6 years ago

Overview

Brief Summary

To evaluate the effect and acceptability of an Internet-based comprehensive behavioral intervention for tics (ICBIT) in a sample of children and adolescents with Tic disorders. children and adolescents (aged 8-17 years) with Tourette Syndrome (TS) or Chronic Tic Disorder (CTD) and their parents will be randomly assigned to receive either an Internet-based ICBIT or wait-list (WL).

Detailed Description

To evaluate the effect and acceptability of an Internet-based comprehensive behavioral intervention for tics (ICBIT) in a sample of children and adolescents with Tic disorders, children and adolescents (aged 8-17 years) with Tourette Syndrome (TS) or Chronic Tic Disorder (CTD) and their parents will be randomly assigned to receive either an Internet-based ICBIT or wait-list (WL) condition in a cross over design. Participants will be randomized to ICBIT, or to wait list, and half will cross over from wait list to ICBT. Two blind independent clinical evaluators will rate tic severity and comorbidity. The primary outcome measure is the Yale Global Tic Severity Scale (YGTSS). Assessments will be performed at baseline, post-ICBT or post wait list, 3-months and 6-months (post-treatment for those originally assigned to ICBT) and post-ICBT, 3-months and 6-months (post-treatment for those originally assigned to wait list condition). All assessments were conducted by 2 PhD level independent child psychologists.

Registry
clinicaltrials.gov
Start Date
July 1, 2019
End Date
May 1, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Tel Aviv Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Michael Rotstein

Head, Pediatric Movement Disorder Clinic, Principal Investigator

Tel-Aviv Sourasky Medical Center

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of Tourette Syndrome or Chronic Tic Disorder.
  • Yale Global Tic Severity Scale tic severity score ≥14.

Exclusion Criteria

  • Change in psychotropic medication regimen during the past 6 weeks.
  • Current diagnosis of substance abuse/dependence.
  • Lifetime diagnosis of pervasive developmental disorder, mania or psychosis.
  • Previous sessions of CBIT.

Outcomes

Primary Outcomes

Yale Global Tic Severity Scale (YGTSS)

Time Frame: change from baseline YGTSS total score at 3 months

Study Sites (2)

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