NCT04087616

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

July 24, 2019

Last Update Submit

September 10, 2019

Conditions

Tourette Syndrome in ChildrenTourette Syndrome in AdolescenceChronic Tic Disorder

Keywords

ticstourette Syndrome

Outcome Measures

Primary Outcomes (1)

  • Yale Global Tic Severity Scale (YGTSS)

    change from baseline YGTSS total score at 3 months

Study Arms (2)

CBIT

EXPERIMENTAL

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

Waiting List

PLACEBO COMPARATOR

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

Interventions

ICBITBEHAVIORAL

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.

CBIT
waiting listBEHAVIORAL

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

Waiting List

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of Tourette Syndrome or Chronic Tic Disorder.
  • Yale Global Tic Severity Scale tic severity score ≥14.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

1Interdisciplinary Center (IDC)

Herzliya, Israel

RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33231786DERIVED

MeSH Terms

Conditions

Tic DisordersTicsTourette Syndrome

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurodevelopmental DisordersMental DisordersDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBasal Ganglia DiseasesBrain DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Central Study Contacts

Lilch Rachamim

CONTACT

+972528374405lilach.rachamim7@gmail.com

Michael Rotstein, MD

CONTACT

+972524266760michaelr@tlvmc.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Pediatric Movement Disorder Clinic, Principal Investigator

Study Record Dates

First Submitted

July 24, 2019

First Posted

September 12, 2019

Study Start

July 1, 2019

Primary Completion

January 31, 2020

Study Completion

May 1, 2020

Last Updated

September 12, 2019

Record last verified: 2019-09

Locations

IL(2)