Internet-based CBIT for Children With Chronic Tics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-05-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Tourette Syndrome in Children Tourette Syndrome in Adolescence Chronic Tic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

ICBIT

Intervention Type BEHAVIORAL

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 receive no psychosocial intervention for 9 weeks. Following post-WL assessment, all participants receive ICBIT.

Group Type PLACEBO_COMPARATOR

waiting list

Intervention Type BEHAVIORAL

Participants initially assigned to the wait list received no psychosocial intervention for 9 weeks. Following post-WL assessment, all participants chose to receive ICBIT.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes