TicHelper: A Computerized Comprehensive Behavioral Intervention for Tics (CBIT) (NCT02413216) | Clinical Trial Compass
CompletedNot Applicable
TicHelper: A Computerized Comprehensive Behavioral Intervention for Tics (CBIT)
United States55 participantsStarted 2015-08
Plain-language 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.
Who can participate
Age range
8 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Total Tic Severity Score on the Yale Global Tic Severity Scale (YGTSS)
. 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.