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

Not Applicable

Withdrawn

• Conditions: Tic Disorders
• Interventions: Drug: Aripiprazole 5Mg Oral Tablet; Behavioral: comprehensive behavioral intervention therapy (CBIT)

• Registration Number: NCT04765085
• Lead Sponsor: Children's Hospital of Fudan University

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;

Study Timeline

• Study First Submitted: 2020-08-21
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-18
• Last Update Submitted: 2021-02-18
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-21
• Study Start: 2021-03
• Primary Completion: 2022-06
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug therapy Group	Aripiprazole 5Mg Oral Tablet	Patients in this group would only receive the drug therapy.
CBIT Group	comprehensive behavioral intervention therapy (CBIT)	Patients in this group would only receive the CBIT treatment.

Primary Outcome Measures

Name	Time	Method
Reduction rate of Tic symptom severity before and after intervention	Baseline, the tenth week of treatment	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

Name	Time	Method
overall treatment response	The fifth week and the tenth week of treatment and three month after treatment end	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	The fifth week and the tenth week of treatment and three month after treatment end	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).