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

Primary Purpose

Tourette's Disorder, Persistent (Chronic) Motor or Vocal Tic Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

TicHelper

Internet Based Resources

About this trial

This is an interventional treatment trial for Tourette's Disorder focused on measuring Tic Disorder, Tourette, Motor tic, Vocal tic, Habit reversal training, CBIT, TicHelper, Behavior Therapy

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Child and parent are English speaking.
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.
Child scores >70 on a brief intelligence test
Child currently engages in at least one motor and/or vocal tic multiple times per day
Clinician rated tic severity score of > 3 (mildly ill or worse)
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.
Family has daily access to a personal computer with internet access and software meeting TicHelper minimum system requirements.

Exclusion Criteria:

A Yale-Global Tic Severity Scale (YGTSS) score > 30
Child scores < 70 on intelligence test
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.
Current or past non-drug treatment for tics that consisted of 4 or more sessions of habit reversal training or CBIT.
Child has lifetime diagnosis of mania or psychotic disorder
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.

Sites / Locations

University of Utah
Marquette University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TicHelper

Internet-Based Resources Condition

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Clinician interview to assess overall severity of tics

Secondary Outcome Measures

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

Measures clinician's impression of overall severity

Clinician Global Impressions-Improvement Scale

Measures clinician's impression of improvement since starting treatment

Clinician Global Impressions- Improvement Scale

Measures clinician's impression of improvement since starting treatment

Full Information

NCT ID

NCT02413216

First Posted

April 1, 2015

Last Updated

December 14, 2017

Sponsor

University of Utah

Collaborators

Marquette University

1. Study Identification

Unique Protocol Identification Number

NCT02413216

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

August 2015 (undefined)

Primary Completion Date

June 1, 2017 (Actual)

Study Completion Date

August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Utah

Collaborators

Marquette University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tourette's Disorder, Persistent (Chronic) Motor or Vocal Tic Disorder

Keywords

Tic Disorder, Tourette, Motor tic, Vocal tic, Habit reversal training, CBIT, TicHelper, Behavior Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TicHelper

Arm Type

Experimental

Arm Description

Arm Title

Internet-Based Resources Condition

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

TicHelper

Other Intervention Name(s)

Habit Reversal Training, Comprehensive Behavioral Intervention for Tics

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Internet Based Resources

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Clinician interview to assess overall severity of tics

Time Frame

Baseline, Week 8 (post-treatment), Week 12 (1-month follow-up)

Secondary Outcome Measure Information:

Title

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

Description

Measures clinician's impression of overall severity

Time Frame

Baseline, Week 8 (post-treatment), Week 12 (1-month follow-up)

Title

Clinician Global Impressions-Improvement Scale

Description

Measures clinician's impression of improvement since starting treatment

Time Frame

Week 8 (post-treatment)

Title

Clinician Global Impressions- Improvement Scale

Description

Measures clinician's impression of improvement since starting treatment

Time Frame

Week 12 (1-month follow-up)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Child and parent are English speaking. 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. Child scores >70 on a brief intelligence test Child currently engages in at least one motor and/or vocal tic multiple times per day Clinician rated tic severity score of > 3 (mildly ill or worse) 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. Family has daily access to a personal computer with internet access and software meeting TicHelper minimum system requirements. Exclusion Criteria: A Yale-Global Tic Severity Scale (YGTSS) score > 30 Child scores < 70 on intelligence test 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. Current or past non-drug treatment for tics that consisted of 4 or more sessions of habit reversal training or CBIT. Child has lifetime diagnosis of mania or psychotic disorder 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael B Himle, Ph.D.

Organizational Affiliation

University of Utah

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Douglas W Woods, Ph.D.

Organizational Affiliation

Marquette University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Suzanne Mouton-Odum, Ph.D.

Organizational Affiliation

PsycTech, Ltd.

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Facility Name

Marquette University

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53201

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20483969

Citation

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.

Results Reference

background

PubMed Identifier

21555779

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.

Results Reference

background

PubMed Identifier

27445874

Citation

Jakubovski E, Reichert C, Karch A, Buddensiek N, Breuer D, Muller-Vahl K. The ONLINE-TICS Study Protocol: A Randomized Observer-Blind Clinical Trial to Demonstrate the Efficacy and Safety of Internet-Delivered Behavioral Treatment for Adults with Chronic Tic Disorders. Front Psychiatry. 2016 Jun 30;7:119. doi: 10.3389/fpsyt.2016.00119. eCollection 2016.

Results Reference

derived

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

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