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UnknownNCT04087616

Internet-based CBIT for Children With Chronic Tics

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Tel Aviv Medical Center · Academic / Other
Sex
All
Age
8 Years – 17 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

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

Timeline

Start date
2019-07-01
Primary completion
2020-01-31
Completion
2020-05-01
First posted
2019-09-12
Last updated
2019-09-12

Locations

2 sites across 1 country: Israel

Source: ClinicalTrials.gov record NCT04087616. Inclusion in this directory is not an endorsement.

Internet-based CBIT for Children With Chronic Tics (NCT04087616) · Clinical Trials Directory