Behavioral Therapy for Children and Adolescents With Tourette Syndrome: A Randomized Controlled Trial in Taiwan
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Taipei Medical University
- Enrollment
- 46
- Primary Endpoint
- Eefficacy of a behavioral therapy on improving tics 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (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.
Eligibility Criteria
- Ages
- 6 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Behavioral Therapy with TS
habit reversal training (HRT)
Intervention: habit reversal training (HRT) (Behavioral)
observational
observational and usual care Pyridoxine(50mg)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Chang, Hsiu-Ju
professor
Taipei Medical University