Back to resultsBehavioral Therapy for Tourette Syndrome (BTTS:HBTA)
Primary Purpose
Tourette Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapist-directed Behavioral Therapy
Home-based DVD Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Tourette Syndrome focused on measuring Tics, Behavioral therapy, Neurologic Examination
Eligibility Criteria
Inclusion Criteria:
- Meet criteria for TS or a chronic motor/vocal tic disorder (CTD). TS as defined by the TS Classification Study Group, includes onset before 18 years, multiple involuntary motor tics, one or more vocal tics, a waxing and waning course, the gradual replacement of old symptoms with new ones, the presence of tics for more than one year, the absence of other medical explanations for tics, and the observation of tics by a reliable examiner. CTD, criteria are as above, except that only motor or vocal tics are required
- Age 7-13 years, either gender
- Observable tics, achieving a minimum score > 20 for TS or > 15 for CTD on the Total Tic Severity score of the Yale Global Tic Severity Scale (YGTSS)
- Tic symptoms must be severe enough to warrant therapy; [e] Tics are not controlled with current medication or individuals are tic-suppressing drug naïve
- The concurrent use of other tic-suppressing medications will be permitted, if the subject has been on a stable dose for more than six weeks and agrees to maintain a constant dosage throughout the study; [6] The concurrent use of medication for Attention-Deficit Hyperactivity Disorder (ADHD) or Obsessive Compulsive Disorder (OCD) is also permitted if the participant has been on a stable dose for more than six weeks and agrees to maintain a constant dosage throughout the study.
Participants will be included in the study if they have had less than four previous sessions of habit reversal training. The investigators will not allow the study to interfere with simultaneous behavioral treatment. In this study, the investigators will assess whether caregiver-directed behavioral therapy using an instructional DVD will help patients who would like behavioral therapy, but the patients do not live close enough to Johns Hopkins for frequent visits.
Exclusion Criteria:
- Secondary tics
- Significant medical illness or a chronic neurological condition (i.e., seizure disorder, developmental neurological conditions, acquired brain injuries
- Current major depression, generalized anxiety disorder, separation anxiety disorder, psychotic symptoms (based upon clinical evaluation), pervasive developmental disorder, autism, intellectual disability (I.Q. less than 70), anorexia/bulimia, or substance abuse
- Individuals with significant OCD, not controlled by medication, will be excluded
- Four or more previous sessions of habit reversal training.
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Children with Tourette syndrome
Arm Description
Eligible children, between ages 7-13 years, with the diagnosis of Tourette syndrome or chronic motor/vocal tic disorder will be recruited from the Tourette Syndrome Clinics at Johns Hopkins (Dr. Singer). The Johns Hopkins Center has been acclaimed a Center of Excellence by the Tourette Association of America. This center currently follows more than 1,000 tic patients and averages 4-6 new referrals and 4 follow up patients weekly. Children will be randomly assigned to either the Therapist-directed Behavioral Therapy group or the Home-based DVD therapy group.
Outcomes
Primary Outcome Measures
The Yale Global Tic Severity Scale Total Tic Score (TTS)
The YGTSS is a clinician-rated measure that begins with the completion of a checklist of all tics present in the past week. Current motor and vocal tics are then rated on 5 dimensions 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 and summed to yield separate motor and vocal tic subscale scores (range 0-25). These subscales are then combined to produce a total tic severity score (range 0-50). An associated impairment scale (range 0-50) assesses tic-related disability during the past week. The YGTSS has demonstrated acceptable internal consistency and acceptable convergent and divergent validity.
Secondary Outcome Measures
Clinical Global Impressions-Improvement scale (CGI)
The Clinical Global Impressions-Improvement scale (CGI-I) is a clinician rating to assess overall clinical improvement based on observed and patient-reported symptom severity and symptom-related impairment. Scores range from 1 to 7 where: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. Responders are defined as those who receive a score of 1 or 2 on the CGI-I.
Full Information
NCT ID
NCT03019731
First Posted
December 14, 2016
Last Updated
March 31, 2021
Sponsor
Johns Hopkins University
Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc., Tourette Association of America
1. Study Identification
Unique Protocol Identification Number
NCT03019731
Brief Title
Behavioral Therapy for Tourette Syndrome
Acronym
BTTS:HBTA
Official Title
Behavioral Therapy for Tourette Syndrome: Home-Based and Therapist-Administered
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 21, 2017 (Actual)
Primary Completion Date
March 21, 2019 (Actual)
Study Completion Date
March 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc., Tourette Association of America
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research is being done to determine whether a home-based behavioral therapy can be successfully used to treat tics in children with Tourette syndrome (TS). Behavioral therapy administered by a trained therapist has been shown to be helpful in reducing tics in children with Tourette syndrome. In this study, the investigators want to determine whether an instructional video can provide parents of children with TS with the tools necessary to successfully use behavioral therapy at home. The investigators also want to determine the effectiveness of home-based behavioral therapy as compared to improvement achieved when the therapy is provided by a trained therapist.
Detailed Description
Tourette syndrome (TS) is a neurodevelopmental disorder with childhood onset characterized by the presence of chronic motor and vocal (phonic) tics. Tics typically begin between the ages of 4 - 7 years, frequently persist, and often lead to psychosocial, physical, functional, and academic difficulties. Epidemiological studies have shown that about 20-30% of children exhibit tics in a classroom setting whereas the estimated prevalence of impairing cases of TS is 1/100 - 1/1000 individuals. There is no cure for tics and a variety of behavioral and pharmacotherapies have been used successfully to suppress tics. Comprehensive Behavioral Intervention for Tics (CBIT) has been shown to be beneficial in several large trials as has habit reversal training (HRT), one of its major components. In the past, it has been suggested that only "competent and trained practitioners should administer CBIT." This proposal challenges that concept and believes that one can establish a successful front-line home-based CBIT treatment program that would be beneficial for the treatment of patients with tic symptoms throughout the country.
CBIT is a safe, effective, front-line treatment for TS. Nevertheless, the investigators emphasize the acute shortage of appropriately trained clinicians available to assist affected individuals. Hence, in this proposal the investigators will assess the effectiveness of a behavioral home-based, parent administered treatment by investigating at Johns Hopkins Hospital whether the home-based digital video disc (DVD) reduces tic severity comparable to that achieved with face-to-face treatment administered by an experienced therapist. The investigators' confidence in the success of this project is based on prior experiences with another childhood movement disorder, primary complex motor stereotypies. The potential significance of this project is enormous, recognizing that home-based therapy reduces health care costs, visits to practitioners, the need to train large numbers of therapists, and most importantly provides direct, available care for a greater number individuals affected with tics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome
Keywords
Tics, Behavioral therapy, Neurologic Examination
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Children with Tourette syndrome
Arm Type
Experimental
Arm Description
Eligible children, between ages 7-13 years, with the diagnosis of Tourette syndrome or chronic motor/vocal tic disorder will be recruited from the Tourette Syndrome Clinics at Johns Hopkins (Dr. Singer). The Johns Hopkins Center has been acclaimed a Center of Excellence by the Tourette Association of America. This center currently follows more than 1,000 tic patients and averages 4-6 new referrals and 4 follow up patients weekly. Children will be randomly assigned to either the Therapist-directed Behavioral Therapy group or the Home-based DVD therapy group.
Intervention Type
Behavioral
Intervention Name(s)
Therapist-directed Behavioral Therapy
Intervention Description
The therapist-directed behavioral therapy group will have their first appointment scheduled within one week of assignment. In the Therapist-directed face-face training program, training instructions will be manualized, in order to match the parent instructional guidelines provided in the home-based DVD. This manual will include the specific psychoeducation, awareness training, competing response training, differential reinforcement of incompatible behaviors, and other adaptive behavioral instructions contained within the home-based DVD. The therapist will match the sequence and required components within the behavior-based training DVD. Face-face training will be administered across 10 weeks (6 weekly sessions followed by 2 bi-weekly sessions).
Intervention Type
Behavioral
Intervention Name(s)
Home-based DVD Therapy
Intervention Description
In order to mimic the slight delay between randomization and start of the therapist-directed treatment, those assigned to the Home-based DVD cohort will have the DVD and training materials mailed to their homes. Parents will also receive a written instructional form and a log sheet for tracking the use of the DVD and the time and duration of practice sessions. Any questions regarding patient care and treatment will be directed to Dr. Singer.
Primary Outcome Measure Information:
Title
The Yale Global Tic Severity Scale Total Tic Score (TTS)
Description
The YGTSS is a clinician-rated measure that begins with the completion of a checklist of all tics present in the past week. Current motor and vocal tics are then rated on 5 dimensions 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 and summed to yield separate motor and vocal tic subscale scores (range 0-25). These subscales are then combined to produce a total tic severity score (range 0-50). An associated impairment scale (range 0-50) assesses tic-related disability during the past week. The YGTSS has demonstrated acceptable internal consistency and acceptable convergent and divergent validity.
Time Frame
Baseline (0 weeks)
Secondary Outcome Measure Information:
Title
Clinical Global Impressions-Improvement scale (CGI)
Description
The Clinical Global Impressions-Improvement scale (CGI-I) is a clinician rating to assess overall clinical improvement based on observed and patient-reported symptom severity and symptom-related impairment. Scores range from 1 to 7 where: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. Responders are defined as those who receive a score of 1 or 2 on the CGI-I.
Time Frame
Baseline (0 weeks)
Other Pre-specified Outcome Measures:
Title
Parent Tic Questionnaire (PTQ)
Description
The Parent Tic Questionnaire (PTQ) measures the number, frequency, intensity of motor and vocal tics. For each tic endorsed in a checklist of common motor and vocal tics over the past week, the parent rates its frequency (4 = constantly, 3 = hourly, 2 = daily, 1 = weekly, 0 = absent) and intensity or noticeable (1-4). An overall score is computed by summing the motor and vocal tic subscale scores. The PTQ has been shown to have excellent internal consistency and test-retest reliability.
Time Frame
Baseline (0 weeks)
Title
The Yale Global Tic Severity Scale Total Tic Score (TTS)
Description
The YGTSS is a clinician-rated measure that begins with the completion of a checklist of all tics present in the past week. Current motor and vocal tics are then rated on 5 dimensions 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 and summed to yield separate motor and vocal tic subscale scores (range 0-25). These subscales are then combined to produce a total tic severity score (range 0-50). An associated impairment scale (range 0-50) assesses tic-related disability during the past week. The YGTSS has demonstrated acceptable internal consistency and acceptable convergent and divergent validity.
Time Frame
At 5 weeks
Title
Clinical Global Impressions-Improvement scale (CGI)
Description
The Clinical Global Impressions-Improvement scale (CGI-I) is a clinician rating to assess overall clinical improvement based on observed and patient-reported symptom severity and symptom-related impairment. Scores range from 1 to 7 where: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. Responders are defined as those who receive a score of 1 or 2 on the CGI-I.
Time Frame
At 5 weeks
Title
Parent Tic Questionnaire (PTQ)
Description
The Parent Tic Questionnaire (PTQ) measures the number, frequency, intensity of motor and vocal tics. For each tic endorsed in a checklist of common motor and vocal tics over the past week, the parent rates its frequency (4 = constantly, 3 = hourly, 2 = daily, 1 = weekly, 0 = absent) and intensity or noticeable (1-4). An overall score is computed by summing the motor and vocal tic subscale scores. The PTQ has been shown to have excellent internal consistency and test-retest reliability.
Time Frame
At 5 weeks
Title
The Yale Global Tic Severity Scale Total Tic Score (TTS)
Description
The YGTSS is a clinician-rated measure that begins with the completion of a checklist of all tics present in the past week. Current motor and vocal tics are then rated on 5 dimensions 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 and summed to yield separate motor and vocal tic subscale scores (range 0-25). These subscales are then combined to produce a total tic severity score (range 0-50). An associated impairment scale (range 0-50) assesses tic-related disability during the past week. The YGTSS has demonstrated acceptable internal consistency and acceptable convergent and divergent validity.
Time Frame
At 10 weeks
Title
Clinical Global Impressions-Improvement scale (CGI)
Description
The Clinical Global Impressions-Improvement scale (CGI-I) is a clinician rating to assess overall clinical improvement based on observed and patient-reported symptom severity and symptom-related impairment. Scores range from 1 to 7 where: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. Responders are defined as those who receive a score of 1 or 2 on the CGI-I.
Time Frame
At 10 weeks
Title
Parent Tic Questionnaire (PTQ)
Description
The Parent Tic Questionnaire (PTQ) measures the number, frequency, intensity of motor and vocal tics. For each tic endorsed in a checklist of common motor and vocal tics over the past week, the parent rates its frequency (4 = constantly, 3 = hourly, 2 = daily, 1 = weekly, 0 = absent) and intensity or noticeable (1-4). An overall score is computed by summing the motor and vocal tic subscale scores. The PTQ has been shown to have excellent internal consistency and test-retest reliability.
Time Frame
At 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet criteria for TS or a chronic motor/vocal tic disorder (CTD). TS as defined by the TS Classification Study Group, includes onset before 18 years, multiple involuntary motor tics, one or more vocal tics, a waxing and waning course, the gradual replacement of old symptoms with new ones, the presence of tics for more than one year, the absence of other medical explanations for tics, and the observation of tics by a reliable examiner. CTD, criteria are as above, except that only motor or vocal tics are required
Age 7-13 years, either gender
Observable tics, achieving a minimum score > 20 for TS or > 15 for CTD on the Total Tic Severity score of the Yale Global Tic Severity Scale (YGTSS)
Tic symptoms must be severe enough to warrant therapy; [e] Tics are not controlled with current medication or individuals are tic-suppressing drug naïve
The concurrent use of other tic-suppressing medications will be permitted, if the subject has been on a stable dose for more than six weeks and agrees to maintain a constant dosage throughout the study; [6] The concurrent use of medication for Attention-Deficit Hyperactivity Disorder (ADHD) or Obsessive Compulsive Disorder (OCD) is also permitted if the participant has been on a stable dose for more than six weeks and agrees to maintain a constant dosage throughout the study.
Participants will be included in the study if they have had less than four previous sessions of habit reversal training. The investigators will not allow the study to interfere with simultaneous behavioral treatment. In this study, the investigators will assess whether caregiver-directed behavioral therapy using an instructional DVD will help patients who would like behavioral therapy, but the patients do not live close enough to Johns Hopkins for frequent visits.
Exclusion Criteria:
Secondary tics
Significant medical illness or a chronic neurological condition (i.e., seizure disorder, developmental neurological conditions, acquired brain injuries
Current major depression, generalized anxiety disorder, separation anxiety disorder, psychotic symptoms (based upon clinical evaluation), pervasive developmental disorder, autism, intellectual disability (I.Q. less than 70), anorexia/bulimia, or substance abuse
Individuals with significant OCD, not controlled by medication, will be excluded
Four or more previous sessions of habit reversal training.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harvey Singer, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Behavioral Therapy for Tourette Syndrome
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