TicHelper: A Computerized Comprehensive Behavioral Intervention for Tics (CBIT)

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Brief Title

TicHelper: A Computerized Comprehensive Behavioral Intervention for Tics (CBIT)

Official Title

Creating a Computerized Self-administered Version of Comprehensive Behavioral Intervention for Tics

Brief Summary

      Tic Disorders (including Tourette Disorder) are relatively common in school-age children and
      for some children can lead to significant psychosocial and physical impairment and diminished
      quality of life. Non-pharmacological treatments have been shown to be effective for reducing
      tics in some children. These treatment options are desired by parents, but are not widely
      available. The investigators recently developed an online, computerized, self-administered
      version of CBIT called TicHelper.com. The current study will test the efficacy of
      TicHelper.com in a randomized clinical trial.

Detailed Description

      Effective non-pharmacological treatment options such as comprehensive behavioral intervention
      for tics (CBIT) have been shown to be effective for reducing tics in some children with
      chronic tic disorders, including Tourette's disorder. Although effective, many parents and
      children do not have access to a provider trained in these therapies and practical barriers
      such as travel and high costs for ongoing therapy limit treatment dissemination and
      utilization.The investigators recently developed an online, computerized, self-administered
      version of CBIT called TicHelper.com. This program is an 8-week online program designed to
      teach children and families empirically-supported tic management skills. The current study
      will test the efficacy of TicHelper.com in a randomized clinical trial in which 64 children
      with Tourette's Disorder or a persistent (chronic) tic disorder will be randomly assigned to
      8-weeks of TicHelper.com (N=32) or an 8-week internet resource control condition (N=32). Tic
      symptoms will be assessed by a condition-blind independent evaluator at baseline,
      post-treatment, and 1-month follow-up. Information regarding patient acceptability of the
      program will also be collected. This project will test whether TicHelper.com is an
      efficacious and acceptable way to teach tic-management skills for children with tics.

Study Type

Interventional

Primary Outcome

Change in the Total Tic Severity Score on the Yale Global Tic Severity Scale (YGTSS)

Secondary Outcome

 Change in overall tic severity on the Clinician Global Impressions-Severity Scale

Condition

Tourette's Disorder

Intervention

TicHelper

Study Arms / Comparison Groups

 TicHelper
Description:  In this condition, participants will be provided with a secure username and login information for TicHelper.com. Participants will be asked to log in and use TicHelper.com for 8 weeks as instructed by the program (TicHelper recommends 30-60 minutes of website and therapeutic activity per day). TicHelper.com consists of 3 modules: Education, Assessment, and Intervention. The education module provides information about tic disorders and treatment. The assessment module tracks progress through the program. The intervention module uses interactive activities to teach tic management skills including habit reversal training (HRT). During HRT, patients learn to become more aware of tics and pre-tic sensations and to subsequently interrupt tics. Participants will also learn ways to interact with each other regarding tics, to identify and alter tic-worsening factors, and relaxation strategies to reduce stress.

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

55

Start Date

August 2015

Completion Date

August 31, 2017

Primary Completion Date

June 1, 2017

Eligibility Criteria

        Inclusion Criteria:

          1. Child and parent are English speaking.

          2. Child meets diagnostic criteria for Tourette's disorder or persistent (chronic) motor
             or vocal tic disorder according to the criteria of the Diagnostic and Statistical
             Manual of Mental Disorders - 5th Edition.

          3. Child scores >70 on a brief intelligence test

          4. Child currently engages in at least one motor and/or vocal tic multiple times per day

          5. Clinician rated tic severity score of > 3 (mildly ill or worse)

          6. Child is unmedicated for tics or associated conditions or has been on stable
             psychotropic medication for at least 6 weeks with no changes or planned changes in
             dosage.

          7. Family has daily access to a personal computer with internet access and software
             meeting TicHelper minimum system requirements.

        Exclusion Criteria:

          1. A Yale-Global Tic Severity Scale (YGTSS) score > 30

          2. Child scores < 70 on intelligence test

          3. Child meets diagnostic criteria for substance abuse or dependence or conduct disorder
             (within past 3 months) according to the criteria of the Diagnostic and Statistical
             Manual of Mental Disorders - 5th Edition.

          4. Current or past non-drug treatment for tics that consisted of 4 or more sessions of
             habit reversal training or CBIT.

          5. Child has lifetime diagnosis of mania or psychotic disorder

          6. Child has any serious psychiatric or neurological condition not currently being
             managed, managed ineffectively, or requiring more immediate treatment other than that
             provided by the study.

Gender

All

Ages

8 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Michael B Himle, Ph.D., ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02413216

Organization ID

2R44MH096344-02

Responsible Party

Principal Investigator

Study Sponsor

University of Utah

Collaborators

 Marquette University

Study Sponsor

Michael B Himle, Ph.D., Principal Investigator, University of Utah

Verification Date

December 2017