Tic Disorders Clinical Trial
Official title:
Study on the Clinical Efficacy and Change of Life Quality Through Using the Comprehensive Behavioral Intervention Treatment for Tics (CBIT)
NCT number | NCT04765085 |
Other study ID # | Sunjinhua |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2021 |
Est. completion date | September 2022 |
Verified date | February 2021 |
Source | Children's Hospital of Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study on the clinical efficacy and change of life quality through using the Comprehensive Behavioral Intervention Treatment for Tics (CBIT)
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 9 Years to 16 Years |
Eligibility | Inclusion Criteria: - Meets the diagnostic criteria for chronic tic disorder or Tourette syndrome (TS) according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), and has been diagnosed by two pediatric psychiatrists who are associate chief physicians or more; - The age ranged from 9 to 16 years old; - The total score of tic symptoms in the Yale global Tic Severity Scale (YGTSS) is 13-30; - Childrens Webster's Intelligence Scale = 85 - Co-morbid ADHD, but the drug treatment dose for ADHD is stable (the drug has been stabilized for more than 6 weeks), or no drug has been taken at the beginning and during the stud Exclusion Criteria: - There are brain organic diseases, metabolic diseases, psychiatric disorders, drug-induced involuntary movement and other extrapyramidal lesions; - Habit reversal training and other behavioral treatments for more than 4 weeks; - unwilling participants or disobedient subgroups in the study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Fudan University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction rate of Tic symptom severity before and after intervention | Tic symptom severity is estimated by Yale Global Tic Severity Scale Total Tic score. The YGTSS is a clinician-rated scale used to assess tic severity over the prior week. It includes a checklist of motor and vocal tics followed by an assessment of the number, frequency, intensity, complexity, and inference of motor tics and phonic tics-scored separately. Each of these dimensions is scored on a 0 to 5 scale. The YGTSS provides three tic severity scores: Total Motor (0 to 25); Total Phonic (0 to 25) and the combined Total Tic Severity Score (0 to 50), as well as a separate Impairment dimension scored from0 to 50. The Total Tic Score (YGTSS-TTS) was used in these analyses.Lower scores indicate improvement and higher scores indicate worsening.
Reduction rate = (YGTSS total score before intervention - YGTSS total score after intervention) / YGTSS total score before treatment × 100% |
Baseline, the tenth week of treatment | |
Secondary | overall treatment response | The overall treatment response is measured by CG-I. This is a repeated measurement variable.The CGI-I was used to measure overall treatment response. The scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). We defined positive response as a score of 1 or 2 (much improved or very much improved). | The fifth week and the tenth week of treatment and three month after treatment end | |
Secondary | life quality | Pediatric Quality of Life Inventory (PedsQL) and Child Tourette's Syndrome Impairment Scale(CTIM) were used to assessed health-related QoL.This is a repeated measurement variable.
PedsQL was a widely used 15-item measure assessed health-related QoL. Parents were asked to rate how often a particular item had been a problem during the past month using a 5-point Likert scale ranging from ''never a problem'' to ''almost always a problem." Total scores were linearly transformed to a scale of 0 to 100. Higher scores indicated better QoL. Four subscales measured physical, emotional, social, and school functioning. The CTIM-P is a 37-item parent-rated instrument that includes school, home, and social activities that may be impaired by their child's tics or a co-morbid problem (e.g., obsessive-compulsive symptoms, depressed mood, anxiety, oppositional/disruptive behavior, hyperactivity, inattentiveness). |
The fifth week and the tenth week of treatment and three month after treatment end |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05370391 -
Comprehensive Behavioral Intervention for Tics
|
N/A | |
Completed |
NCT04007913 -
Incorporating teleCBIT Into a Hospital-Based Tic Program
|
N/A | |
Completed |
NCT00241176 -
Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder
|
Phase 4 | |
Completed |
NCT04498364 -
Extinction Learning in Adults With Tourette Syndrome
|
N/A | |
Recruiting |
NCT03844919 -
TICS: Transcranial Magnetic Stimulation for Intervening in Children With Tourette's Syndrome (CIHR)
|
N/A | |
Not yet recruiting |
NCT06081348 -
Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
|
Phase 2 | |
Completed |
NCT00231985 -
Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder
|
Phase 2 | |
Recruiting |
NCT06050369 -
Objective Characterizatoion of Repetitive Behaviors
|
N/A | |
Completed |
NCT04578912 -
Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics
|
N/A | |
Completed |
NCT03483493 -
Online Remote Behavioural Intervention for Tics (ORBIT)
|
N/A | |
Recruiting |
NCT06408662 -
Remote Delivery of a Mindfulness-based Intervention for Tics
|
N/A | |
Completed |
NCT02676492 -
A Naturalistic Study Investigating Sleep and Cognitive Learning in Children With and Without Tic Disorders
|
N/A | |
Recruiting |
NCT01860300 -
Efficacy of Amoxicilline/Clavulanic Acid in Patients Affected by Tic Disorder Colonized by Group A Streptococcus
|
N/A | |
Completed |
NCT00001667 -
Genotype/Phenotype Correlation of Movement Disorders and Other Neurological Diseases
|
N/A | |
Completed |
NCT00056420 -
Brain Dynamics Involved in Generating Tics and Controlling Voluntary Movement
|
N/A | |
Completed |
NCT04128397 -
An Exploratory Study of Continuous Theta Burst Stimulation (cTBS) Based on fMRI in the Treatment of Tic Disorder
|
N/A | |
Recruiting |
NCT05547854 -
Evaluation of an Online Comprehensive Behavioral Intervention for Tics (CBIT) Therapist Training Program
|
N/A | |
Completed |
NCT05047705 -
Investigating Distress Tolerance in Adults With Tourette Syndrome
|
N/A | |
Completed |
NCT03564132 -
Evaluating the Efficacy and Safety of Yi-Gan San in Children and Adolescents With Tourette's Disorder
|
Phase 2 | |
Completed |
NCT03239210 -
Effects of Ondansetron in Obsessive-compulsive and Tic Disorders
|
Phase 4 |