Behavioral Therapy for Tourette Syndrome

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Brief Title

Behavioral Therapy for Tourette Syndrome

Official Title

Behavioral Therapy for Tourette Syndrome: Home-Based and Therapist-Administered

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.
    


Study Type

Interventional


Primary Outcome

The Yale Global Tic Severity Scale Total Tic Score (TTS)

Secondary Outcome

 Clinical Global Impressions-Improvement scale (CGI)

Condition

Tourette Syndrome

Intervention

Therapist-directed Behavioral Therapy

Study Arms / Comparison Groups

 Children with Tourette syndrome
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

51

Start Date

March 21, 2017

Completion Date

March 21, 2019

Primary Completion Date

March 21, 2019

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.
      

Gender

All

Ages

7 Years - 13 Years

Accepts Healthy Volunteers

No

Contacts

Harvey Singer, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03019731

Organization ID

IRB00111766


Responsible Party

Sponsor

Study Sponsor

Johns Hopkins University

Collaborators

 Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Sponsor

Harvey Singer, MD, Principal Investigator, Johns Hopkins University


Verification Date

September 2019