Back to resultsBehavioral Therapy for Children and Adolescents With Tourette Syndrome
Primary Purpose
Tourette Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
habit reversal training (HRT)
Sponsored by
About this trial
This is an interventional treatment trial for Tourette Syndrome focused on measuring Tourette syndrome, behavior therapy, children and adolescents
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Behavioral Therapy with TS
observational
Arm Description
habit reversal training (HRT)
observational and usual care Pyridoxine(50mg)
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03621059
First Posted
August 2, 2018
Last Updated
August 7, 2018
Sponsor
Taipei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03621059
Brief Title
Behavioral Therapy for Children and Adolescents With Tourette Syndrome
Official Title
Behavioral Therapy for Children and Adolescents With Tourette Syndrome: A Randomized Controlled Trial in Taiwan
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
September 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome
Keywords
Tourette syndrome, behavior therapy, children and adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Eligible children were randomly assigned by sealed envelope to either intervention or control group. Several methods were used to maintain the treatment blindly, including segregation of assessment and treatment staff and instructions to children and parents to avoid discussions of treatment assignment with the independent evaluators.
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Therapy with TS
Arm Type
Experimental
Arm Description
habit reversal training (HRT)
Arm Title
observational
Arm Type
No Intervention
Arm Description
observational and usual care Pyridoxine(50mg)
Intervention Type
Behavioral
Intervention Name(s)
habit reversal training (HRT)
Intervention Description
The intervention group received 4 sessions during 3months of behavior intervention and then, were reassessed at 3 and 6 months following treatment.
Pyridoxine(50mg)
Primary Outcome Measure Information:
Title
Eefficacy of a behavioral therapy on improving tics with Tourette syndrome
Description
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).
Time Frame
at 3rd month and 6rd months following treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hsiu-ju Chang, PHD
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Behavioral Therapy for Children and Adolescents With Tourette Syndrome
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