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

Tourette's Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413216
• Other study ID #: 2R44MH096344-02
• Status: Completed
• Phase: N/A
• First received: April 1, 2015
• Last updated: December 14, 2017
• Start date: August 2015
• Est. completion date: August 31, 2017

Study information

• Verified date: December 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: August 31, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Persistent (Chronic) Motor or Vocal Tic Disorder
• Tic Disorders
• Tics
• Tourette Syndrome
• Tourette's Disorder

Intervention

Behavioral:
• TicHelper
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.

Other:
• Internet Based Resources
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.

Locations

Country	Name	City	State
United States	Marquette University	Milwaukee	Wisconsin
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Marquette University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Piacentini J, Woods DW, Scahill L, Wilhelm S, Peterson AL, Chang S, Ginsburg GS, Deckersbach T, Dziura J, Levi-Pearl S, Walkup JT. Behavior therapy for children with Tourette disorder: a randomized controlled trial. JAMA. 2010 May 19;303(19):1929-37. doi: 10.1001/jama.2010.607. — View Citation

Woods DW, Piacentini JC, Scahill L, Peterson AL, Wilhelm S, Chang S, Deckersbach T, McGuire J, Specht M, Conelea CA, Rozenman M, Dzuria J, Liu H, Levi-Pearl S, Walkup JT. Behavior therapy for tics in children: acute and long-term effects on psychiatric and psychosocial functioning. J Child Neurol. 2011 Jul;26(7):858-65. doi: 10.1177/0883073810397046. Epub 2011 May 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Total Tic Severity Score on the Yale Global Tic Severity Scale (YGTSS)	Clinician interview to assess overall severity of tics	Baseline, Week 8 (post-treatment), Week 12 (1-month follow-up)
Secondary	Change in overall tic severity on the Clinician Global Impressions-Severity Scale	Measures clinician's impression of overall severity	Baseline, Week 8 (post-treatment), Week 12 (1-month follow-up)
Secondary	Clinician Global Impressions-Improvement Scale	Measures clinician's impression of improvement since starting treatment	Week 8 (post-treatment)
Secondary	Clinician Global Impressions- Improvement Scale	Measures clinician's impression of improvement since starting treatment	Week 12 (1-month follow-up)