Behavioral Therapy for Children and Adolescents With Tourette Syndrome

August 7, 2018 updated by: Chang, Hsiu-Ju, Taipei Medical University

Behavioral Therapy for Children and Adolescents With Tourette Syndrome: A Randomized Controlled Trial in Taiwan

Tourette Syndrome (TS) is a common neuropsychiatric disorder in childhood and adolescence, and often comorbid with psychiatric comorbidity. Antipsychotic medications are usually the first choices, but may associate with adverse effects. Behavioral intervention for TS has been shown to be an effective treatment for children and adolescents, yet have not been performed and evaluated using control trails in Taiwan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

TS is a common neuropsychiatric disorder in childhood and adolescence, and often comorbid with psychiatric comorbidity. Antipsychotic medications are usually the first choices, but may associate with adverse effects. Behavioral intervention for TS has been shown to be an effective treatment for children and adolescents, yet have not been performed and evaluated using control trails in Taiwan. This study therefore was to evaluate the efficacy of a comprehensive behavioral intervention therapy on improving tics and tic-related impairment for children and adolescents with Tourette syndrome.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSM-5 Diagnostic Criteria For Tourette Syndrome
  • Patients aged from 6-15 years who were diagnosed with TS or CTD,
  • Never received any pharmacological treatment
  • Ability to understand the study purpose and/or provide consent for participation independently and via a caregiver serving as a proxy

Exclusion Criteria:

  • Have been diagnosed with another mental illness,
  • Had no physical or medical condition,
  • Had been received CBIT or cognitive behavior therapy before.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral Therapy with TS
habit reversal training (HRT)
Behavioral: habit reversal training (HRT)

The intervention group received 4 sessions during 3months of behavior intervention and then, were reassessed at 3 and 6 months following treatment.

Pyridoxine(50mg)
No Intervention: observational
observational and usual care Pyridoxine(50mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eefficacy of a behavioral therapy on improving tics with Tourette syndrome
Time Frame: at 3rd month and 6rd months following treatment.
Behavioral intervention group led to a significantly greater decrease in total motor score on the Yale Global Tic Severity Scale .The gold-standard measure of tic severity in TS, the YGTSS is a clinician-completed measure consisting of a tic symptom checklist, motor and vocal tic severity ratings, and a global tic impairment rating. To ascertain tic severity ratings, the examiner rates five different dimensions of tic severity each on a 0-5 scale: tic number, frequency, duration, intensity, and complexity. Each of the dimensions is scored separately for motor and vocal tics to produce motor and vocal tic subscale scores (range 0-25). These subscales are then combined to produce a total tic severity score (range 0-50), with higher numbers indicating more severe tics. The YGTSS has demonstrated acceptable internal consistency and acceptable convergent and divergent validity).
at 3rd month and 6rd months following treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Investigators

  • Principal Investigator: hsiu-ju Chang, PHD, Taipei Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

September 30, 2016

Study Completion (Actual)

September 30, 2016

Study Registration Dates

First Submitted

August 2, 2018

First Submitted That Met QC Criteria

August 7, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ju07310520

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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