Clinical trial NCT04087616: Internet-based CBIT for Children With Chronic Tics
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tourette Syndrome in Children
Tourette Syndrome in Adolescence
Chronic Tic Disorder
Keywords: tics
tourette Syndrome
Lead sponsor: Tel Aviv Medical Center
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: change from baseline YGTSS total score at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Herzliya
country: Israel
facility: 1Interdisciplinary Center (IDC)
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
References:
citation: Rachamim L, Zimmerman-Brenner S, Rachamim O, Mualem H, Zingboim N, Rotstein M. Internet-based guided self-help comprehensive behavioral intervention for tics (ICBIT) for youth with tic disorders: a feasibility and effectiveness study with 6 month-follow-up. Eur Child Adolesc Psychiatry. 2022 Feb;31(2):275-287. doi: 10.1007/s00787-020-01686-2. Epub 2020 Nov 24.