Tourette SyndromeBTTS:HBTANCT03019731
Behavioral Therapy for Tourette Syndrome
A study testing Therapist-directed Behavioral Therapy and Home-based DVD Therapy in people with Tourette Syndrome, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Therapist-directed Behavioral Therapy and Home-based DVD Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2017to 21 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioral Therapy for Tourette Syndrome: Home-Based and Therapist-Administered
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.
Read the 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.
- Conditions
- Tourette Syndrome
- Being tested
- Therapist-directed Behavioral Therapy, Home-based DVD Therapy
- Keywords
- Tics, Behavioral therapy, Neurologic Examination
- Medical subject headings
- Tourette Syndrome, Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist-directed Behavioral TherapyBehavioural
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).
Home-based DVD TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Children with Tourette syndrome | Experimental | 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. Receives: Behavioral: Therapist-directed Behavioral Therapy; Behavioral: Home-based DVD Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (0 weeks)
Secondary outcomes (1)
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.
Measured: Baseline (0 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start21 Mar 2017
- Primary completion21 Mar 2019
- Study completion21 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc., Tourette Association of America
- Responsible party
- Sponsor
- Investigators
- Harvey Singer, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019731
- Sponsor's protocol ID
- IRB00111766
- Acronym
- BTTS:HBTA
- Status last verified
- Sep 2019
- First submitted
- 14 Dec 2016
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Therapy for Tourette Syndrome: Home-Based and Therapist-Administered
- ClinicalTrials.gov ID
- NCT03019731
- Acronym / sponsor ID
- BTTS:HBTA / IRB00111766
- Conditions
- Tourette Syndrome
- Keywords
- Tics, Behavioral therapy, Neurologic Examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc., Tourette Association of America
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 21 Mar 2019 (actual)
- Study completion
- 21 Mar 2019 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Tourette syndrome | Experimental | Behavioral: Therapist-directed Behavioral Therapy, Behavioral: Home-based DVD TherapyEligible 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. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapist-directed Behavioral TherapyThe 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). | Behavioural | Children with Tourette syndrome |
| Home-based DVD TherapyIn 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. | Behavioural | Children with Tourette syndrome |
Primary outcome
The Yale Global Tic Severity Scale Total Tic Score (TTS)
Time frame: Baseline (0 weeks)
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.
1 secondary outcome
Clinical Global Impressions-Improvement scale (CGI)
Time frame: Baseline (0 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harvey Singer, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapist-directed Behavioral Therapy and Home-based DVD Therapy in people with Tourette Syndrome, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Yale Global Tic Severity Scale Total Tic Score (TTS) (time frame: Baseline (0 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.