Internet-based CBIT for Children With Chronic Tics

Tourette Syndrome in Adolescence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04087616
• Other study ID #: TelAvivSMO
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: September 2019
• Source: Tel Aviv Medical Center
• Contact: Lilch Rachamim
• Phone: +972528374405
• Email: lilach.rachamim7[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 1, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Tic Disorder
• Syndrome
• Tic Disorders
• Tourette Syndrome
• Tourette Syndrome in Adolescence
• Tourette Syndrome in Children

Intervention

Behavioral:
• ICBIT
The intervention consists of 9 modules delivered over 9 weeks comprise of age-appropriate texts and descriptive diagrams, animations, films of clinicians demonstrating techniques such as competing response exercising.
• waiting list
Participants initially assigned to the wait list received no psychosocial intervention for 9 weeks. Following post-WL assessment, all participants chose to receive ICBIT.

Locations

Country	Name	City	State
Israel	1Interdisciplinary Center (IDC)	Herzliya
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale Global Tic Severity Scale (YGTSS)		change from baseline YGTSS total score at 3 months