Behavioral Therapy for Tourette Syndrome

NCT03019731 | Completed

• 1 other identifier: IRB00111766
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette Syndrome

Keywords

Tics; Behavioral therapy; Neurologic Examination

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (0 weeks)

Secondary Outcomes (1)

• Clinical Global Impressions-Improvement scale (CGI)

  Baseline (0 weeks)

Other Outcomes (7)

• Parent Tic Questionnaire (PTQ)

  Baseline (0 weeks)

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

  At 5 weeks

• Clinical Global Impressions-Improvement scale (CGI)

  At 5 weeks

Study Arms (1)

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.

Behavioral: Therapist-directed Behavioral Therapy; Behavioral: Home-based DVD Therapy

Interventions

Therapist-directed Behavioral Therapy BEHAVIORAL

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).

Children with Tourette syndrome

Home-based DVD Therapy BEHAVIORAL

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.

Children with Tourette syndrome

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: collaborator
• Tourette Association of America: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Tourette Syndrome; Tics

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Harvey Singer, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: January 13, 2017
• Study Start: March 21, 2017
• Primary Completion: March 21, 2019
• Study Completion: March 21, 2019
• Last Updated: April 1, 2021

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)