Internet-based CBIT for Children With Chronic Tics

Sponsor

Tel Aviv Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT04087616

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2019

Anticipated Primary Completion Date :

Jan 31, 2020

Anticipated Study Completion Date :

May 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Yale Global Tic Severity Scale (YGTSS) [change from baseline YGTSS total score at 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1Interdisciplinary Center (IDC)	Herzliya		Israel
2	Tel Aviv Sourasky Medical Center	Tel Aviv		Israel

Sponsors and Collaborators

Tel Aviv Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Rotstein, Head, Pediatric Movement Disorder Clinic, Principal Investigator, Tel-Aviv Sourasky Medical Center

ClinicalTrials.gov Identifier:

NCT04087616

Other Study ID Numbers:

TelAvivSMO

First Posted:

Sep 12, 2019

Last Update Posted:

Sep 12, 2019

Last Verified:

Sep 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Michael Rotstein, Head, Pediatric Movement Disorder Clinic, Principal Investigator, Tel-Aviv Sourasky Medical Center

tics

tourette Syndrome

Additional relevant MeSH terms:

Tourette Syndrome

Tic Disorders

Syndrome

Study Results

No Results Posted as of Sep 12, 2019