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

NCT02413216 | Completed

• 1 other identifier: 2R44MH096344-02
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

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

• Clinician Global Impressions-Improvement Scale

  Week 8 (post-treatment)

• Clinician Global Impressions- Improvement Scale

  Week 12 (1-month follow-up)

Study Arms (2)

TicHelper

EXPERIMENTAL

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

Internet-Based Resources Condition

ACTIVE COMPARATOR

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

Interventions

TicHelper BEHAVIORAL

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

TicHelper

Internet Based Resources OTHER

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.

Internet-Based Resources Condition

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• Marquette University: collaborator

Study Sites (2)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Marquette University

Milwaukee, Wisconsin, 53201, United States

Location

Related Publications (3)

• 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.

  PMID: 20483969 BACKGROUND

• 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.

  PMID: 21555779 BACKGROUND

• 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.

  PMID: 27445874 DERIVED

MeSH Terms

Conditions

Tourette Syndrome; Bronchiolitis Obliterans Syndrome; Tic Disorders; Tics

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael B Himle, Ph.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

• Douglas W Woods, Ph.D.

  Marquette University

  PRINCIPAL INVESTIGATOR

• Suzanne Mouton-Odum, Ph.D.

  PsycTech, Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 9, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: August 31, 2017
• Last Updated: December 18, 2017

Record last verified: 2017-12

Locations

US (2)