<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03019731</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00111766</org_study_id>
    <nct_id>NCT03019731</nct_id>
  </id_info>
  <brief_title>Behavioral Therapy for Tourette Syndrome</brief_title>
  <acronym>BTTS:HBTA</acronym>
  <official_title>Behavioral Therapy for Tourette Syndrome: Home-Based and Therapist-Administered</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hugo W. Moser Research Institute at Kennedy Krieger, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tourette Association of America</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research is being done to determine whether a home-based behavioral therapy can be&#xD;
      successfully used to treat tics in children with Tourette syndrome (TS). Behavioral therapy&#xD;
      administered by a trained therapist has been shown to be helpful in reducing tics in children&#xD;
      with Tourette syndrome. In this study, the investigators want to determine whether an&#xD;
      instructional video can provide parents of children with TS with the tools necessary to&#xD;
      successfully use behavioral therapy at home. The investigators also want to determine the&#xD;
      effectiveness of home-based behavioral therapy as compared to improvement achieved when the&#xD;
      therapy is provided by a trained therapist.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tourette syndrome (TS) is a neurodevelopmental disorder with childhood onset characterized by&#xD;
      the presence of chronic motor and vocal (phonic) tics. Tics typically begin between the ages&#xD;
      of 4 - 7 years, frequently persist, and often lead to psychosocial, physical, functional, and&#xD;
      academic difficulties. Epidemiological studies have shown that about 20-30% of children&#xD;
      exhibit tics in a classroom setting whereas the estimated prevalence of impairing cases of TS&#xD;
      is 1/100 - 1/1000 individuals. There is no cure for tics and a variety of behavioral and&#xD;
      pharmacotherapies have been used successfully to suppress tics. Comprehensive Behavioral&#xD;
      Intervention for Tics (CBIT) has been shown to be beneficial in several large trials as has&#xD;
      habit reversal training (HRT), one of its major components. In the past, it has been&#xD;
      suggested that only &quot;competent and trained practitioners should administer CBIT.&quot; This&#xD;
      proposal challenges that concept and believes that one can establish a successful front-line&#xD;
      home-based CBIT treatment program that would be beneficial for the treatment of patients with&#xD;
      tic symptoms throughout the country.&#xD;
&#xD;
      CBIT is a safe, effective, front-line treatment for TS. Nevertheless, the investigators&#xD;
      emphasize the acute shortage of appropriately trained clinicians available to assist affected&#xD;
      individuals. Hence, in this proposal the investigators will assess the effectiveness of a&#xD;
      behavioral home-based, parent administered treatment by investigating at Johns Hopkins&#xD;
      Hospital whether the home-based digital video disc (DVD) reduces tic severity comparable to&#xD;
      that achieved with face-to-face treatment administered by an experienced therapist. The&#xD;
      investigators' confidence in the success of this project is based on prior experiences with&#xD;
      another childhood movement disorder, primary complex motor stereotypies. The potential&#xD;
      significance of this project is enormous, recognizing that home-based therapy reduces health&#xD;
      care costs, visits to practitioners, the need to train large numbers of therapists, and most&#xD;
      importantly provides direct, available care for a greater number individuals affected with&#xD;
      tics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 21, 2017</start_date>
  <completion_date type="Actual">March 21, 2019</completion_date>
  <primary_completion_date type="Actual">March 21, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Yale Global Tic Severity Scale Total Tic Score (TTS)</measure>
    <time_frame>Baseline (0 weeks)</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impressions-Improvement scale (CGI)</measure>
    <time_frame>Baseline (0 weeks)</time_frame>
    <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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Parent Tic Questionnaire (PTQ)</measure>
    <time_frame>Baseline (0 weeks)</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>The Yale Global Tic Severity Scale Total Tic Score (TTS)</measure>
    <time_frame>At 5 weeks</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical Global Impressions-Improvement scale (CGI)</measure>
    <time_frame>At 5 weeks</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Parent Tic Questionnaire (PTQ)</measure>
    <time_frame>At 5 weeks</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>The Yale Global Tic Severity Scale Total Tic Score (TTS)</measure>
    <time_frame>At 10 weeks</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical Global Impressions-Improvement scale (CGI)</measure>
    <time_frame>At 10 weeks</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Parent Tic Questionnaire (PTQ)</measure>
    <time_frame>At 10 weeks</time_frame>
    <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.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Tourette Syndrome</condition>
  <arm_group>
    <arm_group_label>Children with Tourette syndrome</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Therapist-directed Behavioral Therapy</intervention_name>
    <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).</description>
    <arm_group_label>Children with Tourette syndrome</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home-based DVD Therapy</intervention_name>
    <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.</description>
    <arm_group_label>Children with Tourette syndrome</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meet criteria for TS or a chronic motor/vocal tic disorder (CTD). TS as defined by the&#xD;
             TS Classification Study Group, includes onset before 18 years, multiple involuntary&#xD;
             motor tics, one or more vocal tics, a waxing and waning course, the gradual&#xD;
             replacement of old symptoms with new ones, the presence of tics for more than one&#xD;
             year, the absence of other medical explanations for tics, and the observation of tics&#xD;
             by a reliable examiner. CTD, criteria are as above, except that only motor or vocal&#xD;
             tics are required&#xD;
&#xD;
          -  Age 7-13 years, either gender&#xD;
&#xD;
          -  Observable tics, achieving a minimum score &gt; 20 for TS or &gt; 15 for CTD on the Total&#xD;
             Tic Severity score of the Yale Global Tic Severity Scale (YGTSS)&#xD;
&#xD;
          -  Tic symptoms must be severe enough to warrant therapy; [e] Tics are not controlled&#xD;
             with current medication or individuals are tic-suppressing drug naïve&#xD;
&#xD;
          -  The concurrent use of other tic-suppressing medications will be permitted, if the&#xD;
             subject has been on a stable dose for more than six weeks and agrees to maintain a&#xD;
             constant dosage throughout the study; [6] The concurrent use of medication for&#xD;
             Attention-Deficit Hyperactivity Disorder (ADHD) or Obsessive Compulsive Disorder (OCD)&#xD;
             is also permitted if the participant has been on a stable dose for more than six weeks&#xD;
             and agrees to maintain a constant dosage throughout the study.&#xD;
&#xD;
        Participants will be included in the study if they have had less than four previous&#xD;
        sessions of habit reversal training. The investigators will not allow the study to&#xD;
        interfere with simultaneous behavioral treatment. In this study, the investigators will&#xD;
        assess whether caregiver-directed behavioral therapy using an instructional DVD will help&#xD;
        patients who would like behavioral therapy, but the patients do not live close enough to&#xD;
        Johns Hopkins for frequent visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary tics&#xD;
&#xD;
          -  Significant medical illness or a chronic neurological condition (i.e., seizure&#xD;
             disorder, developmental neurological conditions, acquired brain injuries&#xD;
&#xD;
          -  Current major depression, generalized anxiety disorder, separation anxiety disorder,&#xD;
             psychotic symptoms (based upon clinical evaluation), pervasive developmental disorder,&#xD;
             autism, intellectual disability (I.Q. less than 70), anorexia/bulimia, or substance&#xD;
             abuse&#xD;
&#xD;
          -  Individuals with significant OCD, not controlled by medication, will be excluded&#xD;
&#xD;
          -  Four or more previous sessions of habit reversal training.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harvey Singer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>March 31, 2021</last_update_submitted>
  <last_update_submitted_qc>March 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tics</keyword>
  <keyword>Behavioral therapy</keyword>
  <keyword>Neurologic Examination</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tourette Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03019731
org study id: IRB00111766
nct id: NCT03019731
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Yale Global Tic Severity Scale Total Tic Score (TTS)
time frame: Baseline (0 weeks)
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.
measure: Clinical Global Impressions-Improvement scale (CGI)
time frame: Baseline (0 weeks)
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.
measure: Parent Tic Questionnaire (PTQ)
time frame: Baseline (0 weeks)
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.
measure: The Yale Global Tic Severity Scale Total Tic Score (TTS)
time frame: At 5 weeks
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.
measure: Clinical Global Impressions-Improvement scale (CGI)
time frame: At 5 weeks
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.
measure: Parent Tic Questionnaire (PTQ)
time frame: At 5 weeks
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.
measure: The Yale Global Tic Severity Scale Total Tic Score (TTS)
time frame: At 10 weeks
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.
measure: Clinical Global Impressions-Improvement scale (CGI)
time frame: At 10 weeks
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.
measure: Parent Tic Questionnaire (PTQ)
time frame: At 10 weeks
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.
arm group label: Children with Tourette syndrome
arm group type: Experimental
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: Therapist-directed Behavioral Therapy
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).
arm group label: Children with Tourette syndrome
intervention type: Behavioral
intervention name: Home-based DVD Therapy
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.
arm group label: Children with Tourette syndrome
criteria: 
gender: All
minimum age: 7 Years
maximum age: 13 Years
healthy volunteers: No
last name: Harvey Singer, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tourette Syndrome
mesh term: Syndrome
sharing ipd: No