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