Behavioral Therapy for Children and Adolescents With Tourette Syndrome

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Tourette Syndrome

Intervention / Treatment
-----------------
* Behavioral: habit reversal training (HRT)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A collection of behavioral skills named as Comprehensive Behavioral Intervention (CBIT) for Tics had been found to be effective (Piacentini et al., 2010).The major components of CBIT includes psychoeducation of tics, habit reversal training (HRT), function-based interventions, and relaxation training (Piacentini et al., 2010).The HRT consists of several therapeutic activities, including awareness training (i.e., observing the premonitory urge or other signs preceding the occurrence of a tic), competing response training (i.e., engaging in a voluntary behavior that is physically incompatible with the tic to manage the premonitory urge), self-monitoring of tics and relaxation training (Himle et al., 2006).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Therapy with TS<br>habit reversal training (HRT) | Behavioral: habit reversal training (HRT)<br>* The intervention group received 4 sessions during 3months of behavior intervention and then, were reassessed at 3 and 6 months following treatment. Pyridoxine(50mg)<br>|
| No Intervention: observational<br>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 | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tourette syndrome, behavior therapy, children and adolescents