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Internet-based CBIT for Children With Chronic Tics

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ClinicalTrials.gov Identifier: NCT04087616
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Rotstein, Tel-Aviv Sourasky 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).

Condition or disease Intervention/treatment Phase
Tourette Syndrome in Children Tourette Syndrome in Adolescence Chronic Tic Disorder Behavioral: ICBIT Behavioral: waiting list Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CBIT
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.
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.

Placebo Comparator: Waiting List
Participants initially assigned to the wait list receive no psychosocial intervention for 9 weeks. Following post-WL assessment, all participants receive ICBIT.
Behavioral: 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.




Primary Outcome Measures :
  1. Yale Global Tic Severity Scale (YGTSS) [ Time Frame: change from baseline YGTSS total score at 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087616


Contacts
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Contact: Lilch Rachamim +972528374405 lilach.rachamim7@gmail.com
Contact: Michael Rotstein, MD +972524266760 michaelr@tlvmc.gov.il

Locations
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Israel
1Interdisciplinary Center (IDC) Recruiting
Herzliya, Israel
Contact: lilach Rachamim    +972528374405    Lilach Rachamim <lilach.rachamim7@gmail.com>   
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Michael Rotstein, MD    +972524266760    michaelr@tlvmc.gov.il   
Sponsors and Collaborators
Tel Aviv Medical Center

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Responsible Party: Michael Rotstein, Head, Pediatric Movement Disorder Clinic, Principal Investigator, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT04087616     History of Changes
Other Study ID Numbers: TelAvivSMO
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Rotstein, Tel-Aviv Sourasky Medical Center:
tics
tourette Syndrome
Additional relevant MeSH terms:
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Tourette Syndrome
Tic Disorders
Syndrome
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders