Internet-based CBIT for Children With Chronic Tics
Primary Purpose
Tourette Syndrome in Children, Tourette Syndrome in Adolescence, Chronic Tic Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
ICBIT
waiting list
Sponsored by
About this trial
This is an interventional treatment trial for Tourette Syndrome in Children focused on measuring tics, tourette Syndrome
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.
Sites / Locations
- 1Interdisciplinary Center (IDC)Recruiting
- Tel Aviv Sourasky Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CBIT
Waiting List
Arm Description
ICBIT. Intervention delivered through an internet platform called Managing children's' tics (www.cbteamathome.co.il), based on CBIT protocol (Woods et al., 2008) adapted to an online parent-guided self-help format.
Participants initially assigned to the wait list receive no psychosocial intervention for 9 weeks. Following post-WL assessment, all participants receive ICBIT.
Outcomes
Primary Outcome Measures
Yale Global Tic Severity Scale (YGTSS)
Secondary Outcome Measures
Full Information
NCT ID
NCT04087616
First Posted
July 24, 2019
Last Updated
September 10, 2019
Sponsor
Tel Aviv Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04087616
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Anticipated)
Study Completion Date
May 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome in Children, Tourette Syndrome in Adolescence, Chronic Tic Disorder
Keywords
tics, tourette Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBIT
Arm Type
Experimental
Arm Description
ICBIT. Intervention delivered through an internet platform called Managing children's' tics (www.cbteamathome.co.il), based on CBIT protocol (Woods et al., 2008) adapted to an online parent-guided self-help format.
Arm Title
Waiting List
Arm Type
Placebo Comparator
Arm Description
Participants initially assigned to the wait list receive no psychosocial intervention for 9 weeks. Following post-WL assessment, all participants receive ICBIT.
Intervention Type
Behavioral
Intervention Name(s)
ICBIT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
waiting list
Intervention Description
Participants initially assigned to the wait list received no psychosocial intervention for 9 weeks. Following post-WL assessment, all participants chose to receive ICBIT.
Primary Outcome Measure Information:
Title
Yale Global Tic Severity Scale (YGTSS)
Time Frame
change from baseline YGTSS total score at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lilch Rachamim
Phone
+972528374405
Email
lilach.rachamim7@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Rotstein, MD
Phone
+972524266760
Email
michaelr@tlvmc.gov.il
Facility Information:
Facility Name
1Interdisciplinary Center (IDC)
City
Herzliya
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lilach Rachamim
Phone
+972528374405
Email
Lilach Rachamim <lilach.rachamim7@gmail.com>
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Rotstein, MD
Phone
+972524266760
Email
michaelr@tlvmc.gov.il
12. IPD Sharing Statement
Citations:
PubMed Identifier
33231786
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.
Results Reference
derived
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Internet-based CBIT for Children With Chronic Tics
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