Clinical trial NCT03019731: Behavioral Therapy for Tourette Syndrome
Official title: Behavioral Therapy for Tourette Syndrome: Home-Based and Therapist-Administered
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tourette Syndrome
Keywords: Tics
Behavioral therapy
Neurologic Examination
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Tourette Association of America
First posted: 2017-01-13
Enrollment: 51
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Yale Global Tic Severity Scale Total Tic Score (TTS)
timeFrame: Baseline (0 weeks)
Secondary outcomes:
measure: Clinical Global Impressions-Improvement scale (CGI)
timeFrame: Baseline (0 weeks)
Other outcomes:
measure: Parent Tic Questionnaire (PTQ)
timeFrame: Baseline (0 weeks)
measure: The Yale Global Tic Severity Scale Total Tic Score (TTS)
timeFrame: At 5 weeks
measure: Clinical Global Impressions-Improvement scale (CGI)
timeFrame: At 5 weeks
measure: Parent Tic Questionnaire (PTQ)
timeFrame: At 5 weeks
measure: The Yale Global Tic Severity Scale Total Tic Score (TTS)
timeFrame: At 10 weeks
measure: Clinical Global Impressions-Improvement scale (CGI)
timeFrame: At 10 weeks
measure: Parent Tic Questionnaire (PTQ)
timeFrame: At 10 weeks
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Harvey Singer, MD
role: PRINCIPAL_INVESTIGATOR
References: