Clinical trial NCT02413216: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Marquette University
First posted: 2015-04-09
Enrollment: 55
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in the Total Tic Severity Score on the Yale Global Tic Severity Scale (YGTSS)
timeFrame: Baseline, Week 8 (post-treatment), Week 12 (1-month follow-up)
Secondary outcomes:
measure: Change in overall tic severity on the Clinician Global Impressions-Severity Scale
timeFrame: Baseline, Week 8 (post-treatment), Week 12 (1-month follow-up)
measure: Clinician Global Impressions-Improvement Scale
timeFrame: Week 8 (post-treatment)
measure: Clinician Global Impressions- Improvement Scale
timeFrame: Week 12 (1-month follow-up)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Milwaukee
country: United States
facility: Marquette University
state: Wisconsin
Study officials:
affiliation: University of Utah
name: Michael B Himle, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Marquette University
name: Douglas W Woods, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: PsycTech, Ltd.
name: Suzanne Mouton-Odum, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.