Internet-based CBIT for Children With Chronic Tics

Not Applicable

• Conditions: Tourette Syndrome in Adolescence; Tourette Syndrome in Children; Chronic Tic Disorder

• Registration Number: NCT04087616
• Lead Sponsor: Tel Aviv Medical Center

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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-07-24
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-10
• Last Update Submitted: 2019-09-10
• Study First Posted: 2019-09-12
• Last Update Posted: 2019-09-12
• Primary Completion: 2020-01-31
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Yale Global Tic Severity Scale (YGTSS)	change from baseline YGTSS total score at 3 months

Trial Locations

Locations (2)

1Interdisciplinary Center (IDC); 🇮🇱 Herzliya, Israel

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel