Behavioral Therapy for Children and Adolescents With Tourette Syndrome

Sponsor

Taipei Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT03621059

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tourette Syndrome	Behavioral: habit reversal training (HRT)	N/A

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

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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:

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.

Primary Purpose:

Treatment

Official Title:

Behavioral Therapy for Children and Adolescents With Tourette Syndrome: A Randomized Controlled Trial in Taiwan

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Sep 30, 2016

Actual Study Completion Date :

Sep 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Behavioral Therapy with TS habit reversal training (HRT)	Behavioral: habit reversal training (HRT) The intervention group received 4 sessions during 3months of behavior intervention and then, were reassessed at 3 and 6 months following treatment. Pyridoxine(50mg)
No Intervention: observational observational and usual care Pyridoxine(50mg)

Arm

Intervention/Treatment

Experimental: Behavioral Therapy with TS

habit reversal training (HRT)

Behavioral: habit reversal training (HRT)

The intervention group received 4 sessions during 3months of behavior intervention and then, were reassessed at 3 and 6 months following treatment. Pyridoxine(50mg)

No Intervention: observational

observational and usual care Pyridoxine(50mg)

Outcome Measures

Primary Outcome Measures

Eefficacy of a behavioral therapy on improving tics with Tourette syndrome [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 15 Years

Sexes Eligible for Study:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Taipei Medical University

Investigators

Principal Investigator: hsiu-ju Chang, PHD, Taipei Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chang, Hsiu-Ju, professor, Taipei Medical University

ClinicalTrials.gov Identifier:

NCT03621059

Other Study ID Numbers:

ju07310520

First Posted:

Aug 8, 2018

Last Update Posted:

Aug 8, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chang, Hsiu-Ju, professor, Taipei Medical University

Tourette syndrome

behavior therapy

children and adolescents

Additional relevant MeSH terms:

Tourette Syndrome

Syndrome

Study Results

No Results Posted as of Aug 8, 2018