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Clinical Efficacy and Change of Life Quality Through Using the Comprehensive Behavioral Intervention Treatment for Tics

Primary Purpose

Tic Disorders

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
comprehensive behavioral intervention therapy (CBIT)
Aripiprazole 5Mg Oral Tablet
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tic Disorders focused on measuring comprehensive behavioral intervention therapy, drug therapy, Psychosocial education

Eligibility Criteria

9 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    CBIT Group

    Drug therapy Group

    Arm Description

    Patients in this group would only receive the CBIT treatment.

    Patients in this group would only receive the drug therapy.

    Outcomes

    Primary Outcome Measures

    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%

    Secondary Outcome Measures

    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).
    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).

    Full Information

    First Posted
    August 21, 2020
    Last Updated
    February 18, 2021
    Sponsor
    Children's Hospital of Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04765085
    Brief Title
    Clinical Efficacy and Change of Life Quality Through Using the Comprehensive Behavioral Intervention Treatment for Tics
    Official Title
    Study on the Clinical Efficacy and Change of Life Quality Through Using the Comprehensive Behavioral Intervention Treatment for Tics (CBIT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lacking of funding
    Study Start Date
    March 2021 (Anticipated)
    Primary Completion Date
    June 2022 (Anticipated)
    Study Completion Date
    September 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Children's Hospital of Fudan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Study on the clinical efficacy and change of life quality through using the Comprehensive Behavioral Intervention Treatment for Tics (CBIT)
    Detailed Description
    This study tried to explore the clinical effect of comprehensive behavioral intervention therapy (CBIT) on tic symptoms and the effect of improving the quality of life in children with tic disorders;explore the optimal treatment plan for tic disorder by comparing the clinical efficacy of CBIT therapy, drug therapy, and psychosocial education; explore the feasibility of using quality of life as an evaluation index for functional recovery after tic disorder treatment;

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tic Disorders
    Keywords
    comprehensive behavioral intervention therapy, drug therapy, Psychosocial education

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CBIT Group
    Arm Type
    Experimental
    Arm Description
    Patients in this group would only receive the CBIT treatment.
    Arm Title
    Drug therapy Group
    Arm Type
    Experimental
    Arm Description
    Patients in this group would only receive the drug therapy.
    Intervention Type
    Behavioral
    Intervention Name(s)
    comprehensive behavioral intervention therapy (CBIT)
    Intervention Description
    Comprehensive behavioral intervention for tics is an extension of habit reversal training. It includes an expanded set of strategies, such as psycho-education about tic disorders, tic awareness training, competing response training, relaxation training, and functional analysis. According to the CBIT treatment manual (translated by sun Jinhua and Xu Wen, the author were Douglas W. woods et al., Oxford University Press, New York). The treatments consisted of 8 sessions for 10 weeks The first two phases were 1.5 hours, the last six stages were 1 hour.The treatment process was regularly supervised by a treatment supervisor.
    Intervention Type
    Drug
    Intervention Name(s)
    Aripiprazole 5Mg Oral Tablet
    Intervention Description
    Considering the patients with chronic tic disorder (chronic motor or vocal tic disorder or Tourette's disorder), aripiprazole was selected as a single drug with constant dose during the treatment. In case of extrapyramidal side effects, benhexol was given to reduce the extrapyramidal side effects, and the dosage and duration of medication were recorded
    Primary Outcome Measure Information:
    Title
    Reduction rate of Tic symptom severity before and after intervention
    Description
    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%
    Time Frame
    Baseline, the tenth week of treatment
    Secondary Outcome Measure Information:
    Title
    overall treatment response
    Description
    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).
    Time Frame
    The fifth week and the tenth week of treatment and three month after treatment end
    Title
    life quality
    Description
    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).
    Time Frame
    The fifth week and the tenth week of treatment and three month after treatment end

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    Clinical Efficacy and Change of Life Quality Through Using the Comprehensive Behavioral Intervention Treatment for Tics

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