An interventional study of TicHelper and Internet Based Resources in Tourette's Disorder and Persistent (Chronic) Motor or Vocal Tic Disorder, sponsored by University of Utah. Completed at 2 sites in United States. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-12-18.
Sponsored by University of Utah · Not applicable, Interventional, and Treatment
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.
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.
240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.
This study's enrollment of 55 is above the median of 36 across 183 interventional studies indexed under Tourette Syndrome.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: TicHelper
Participants who are assigned to the Internet-Based Resources (IBR) condition will receive a collection of materials with inks to the best available online resources about tic disorders and their treatment. The sites that are provided use a variety of online print, video, and animation materials to teach patients about various aspects of chronic tic disorders and their management. Participants will will be asked to explore and use the website information over the course of 8 weeks in any manner they find helpful. Participants will be asked to spend 30-60 minutes per day reviewing and discussing the information provided.
Other: Internet Based Resources
TicHelper.com is an 8-week online program designed to teach tic management skills. Content and activities included in TicHelper.com are based on existing empirically-supported treatments including Habit Reversal Training (HRT) and Comprehensive Behavioral Intervention for Tics (CBIT). TicHelper.com is designed to teach tic management skills including psychoeducation, relaxation training, awareness training, competing response training, and social support. It is also designed to teach patients/parents to recognize and reduce tic-exacerbating reactions and activities.
Also known as: Habit Reversal Training, Comprehensive Behavioral Intervention for Tics
The Internet-Based Resources (IBR) condition is designed to provide patients/parents with access to a wide range of educational materials. These materials contain up-to-date information regarding what is known about tic disorders and their management. Materials covering medical, educational, and behavioral/psychological topics are provided.
Change in the Total Tic Severity Score on the Yale Global Tic Severity Scale (YGTSS)
Clinician interview to assess overall severity of tics
Time frame: Baseline, Week 8 (post-treatment), Week 12 (1-month follow-up)
Change in overall tic severity on the Clinician Global Impressions-Severity Scale
Measures clinician's impression of overall severity
Time frame: Baseline, Week 8 (post-treatment), Week 12 (1-month follow-up)
Clinician Global Impressions-Improvement Scale
Measures clinician's impression of improvement since starting treatment
Time frame: Week 8 (post-treatment)
Clinician Global Impressions- Improvement Scale
Measures clinician's impression of improvement since starting treatment
Time frame: Week 12 (1-month follow-up)
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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