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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04087616
Other study ID # TelAvivSMO
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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