Tourette's DisorderNCT02413216
TicHelper: A Computerized Comprehensive Behavioral Intervention for Tics (CBIT)
A study testing TicHelper and Internet Based Resources in people with Tourette's Disorder and Persistent (Chronic) Motor or Vocal Tic Disorder, run by University of Utah at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Tourette's Disorder, Persistent (Chronic) Motor or Vocal Tic Disorder
- What is being tested?
- TicHelper and Internet Based Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2015to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Marquette University
Milwaukee, Wisconsin, 53201
University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Creating a Computerized Self-administered Version of Comprehensive Behavioral Intervention for Tics
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.
Read the 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.
- Being tested
- TicHelper, Internet Based Resources
- Keywords
- Tic Disorder, Tourette, Motor tic, Vocal tic, Habit reversal training, CBIT, TicHelper, Behavior Therapy
- Medical subject headings
- Tourette Syndrome, Bronchiolitis Obliterans Syndrome, Tic Disorders, Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicHelperBehavioural
Also called Habit Reversal Training, Comprehensive Behavioral Intervention for Tics
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.
Internet Based ResourcesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Internet Based Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Total Tic Severity Score on the Yale Global Tic Severity Scale (YGTSS)
Clinician interview to assess overall severity of tics
Measured: 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
Measures clinician's impression of overall severity
Measured: 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
Measured: Week 8 (post-treatment)
Clinician Global Impressions- Improvement Scale
Measures clinician's impression of improvement since starting treatment
Measured: Week 12 (1-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startAug 2015
- Primary completion1 Jun 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tourette's DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Marquette University
- Responsible party
- Principal investigator, Mike Himle, University of Utah
- Investigators
- Michael B Himle, Ph.D., Principal investigator, University of UtahDouglas W Woods, Ph.D., Principal investigator, Marquette UniversitySuzanne Mouton-Odum, Ph.D., Principal investigator, PsycTech, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413216
- Sponsor's protocol ID
- 2R44MH096344-02
- Status last verified
- Dec 2017
- First submitted
- 1 Apr 2015
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20483969Woods 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.
PubMed 21555779Jakubovski 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.
PubMed 27445874
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating a Computerized Self-administered Version of Comprehensive Behavioral Intervention for Tics
- ClinicalTrials.gov ID
- NCT02413216
- Acronym / sponsor ID
- 2R44MH096344-02
- Keywords
- Tic Disorder, Tourette, Motor tic, Vocal tic, Habit reversal training, CBIT, TicHelper, Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Marquette University
- Study start
- Aug 2015
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TicHelper | Experimental | Behavioral: TicHelperIn 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. |
| Internet-Based Resources Condition | Active comparator | Other: Internet Based ResourcesParticipants 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicHelperAlso: Habit Reversal Training, Comprehensive Behavioral Intervention for TicsTicHelper.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. | Behavioural | TicHelper |
| Internet Based ResourcesThe 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. | Other | Internet-Based Resources Condition |
Primary outcome
Change in the Total Tic Severity Score on the Yale Global Tic Severity Scale (YGTSS)
Time frame: Baseline, Week 8 (post-treatment), Week 12 (1-month follow-up)
Clinician interview to assess overall severity of tics
3 secondary outcomes
Change in overall tic severity on the Clinician Global Impressions-Severity Scale
Time frame: Baseline, Week 8 (post-treatment), Week 12 (1-month follow-up)
Clinician Global Impressions-Improvement Scale
Time frame: Week 8 (post-treatment)
Clinician Global Impressions- Improvement Scale
Time frame: Week 12 (1-month follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Background: PubMed 20483969Piacentini 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.
- Background: PubMed 21555779Woods 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.
- Derived from this study: PubMed 27445874Jakubovski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Himle, Ph.D. principal investigator
University of Utah
Douglas W Woods, Ph.D. principal investigator
Marquette University
Suzanne Mouton-Odum, Ph.D. principal investigator
PsycTech, Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TicHelper and Internet Based Resources in people with Tourette's Disorder and Persistent (Chronic) Motor or Vocal Tic Disorder, run by University of Utah at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Total Tic Severity Score on the Yale Global Tic Severity Scale (YGTSS) (time frame: Baseline, Week 8 (post-treatment), Week 12 (1-month follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02413216, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.