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
|Condition or disease||Intervention/treatment||Phase|
|Tourette Syndrome in Children Tourette Syndrome in Adolescence Chronic Tic Disorder||Behavioral: ICBIT Behavioral: waiting list||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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.
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.
- Yale Global Tic Severity Scale (YGTSS) [ Time Frame: change from baseline YGTSS total score at 3 months ]
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
|Contact: Lilch Rachamimemail@example.com|
|Contact: Michael Rotstein, MDfirstname.lastname@example.org|
|1Interdisciplinary Center (IDC)||Recruiting|
|Contact: lilach Rachamim +972528374405 Lilach Rachamim <email@example.com>|
|Tel Aviv Sourasky Medical Center||Recruiting|
|Tel Aviv, Israel|
|Contact: Michael Rotstein, MD +972524266760 firstname.lastname@example.org|