Evaluation of an Online Comprehensive Behavioral Intervention for Tics (CBIT) Therapist Training … (NCT05547854) | Clinical Trial Compass
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Evaluation of an Online Comprehensive Behavioral Intervention for Tics (CBIT) Therapist Training Program
United States234 participantsStarted 2023-06-27
Plain-language summary
Tic disorders are a class of childhood-onset neuropsychiatric disorders that occur in 1-3% of the population. Studies have shown that a non-drug treatment known as Comprehensive Behavioral Intervention for Tics (CBIT) is more effective than supportive therapy for reducing tics in children and adults. Although CBIT is now recommended as a first-line intervention for tic disorders, many patients do not have access to CBIT, in part due to a lack of trained therapists. Currently, the only option available for training therapists in CBIT is an intensive, two day, in-person behavior therapy training institute (BTTI). This study will compare the traditional in-person training approach to a recently developed online, self-paced CBIT therapist training program called CBIT-Trainer with regard to (1) therapists' ability to accurately administer CBIT and (2) change in the severity of patients' tic symptoms after being treated by a CBIT-trained therapist.
Who can participate
Age range
7 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
. Have the equivalent of a Master's degree (or higher) in a mental/behavioral health, medical, or related discipline.
. Professionally licensed or certified to practice in their area of speciality.
. Attest that providing comprehensive behavioral intervention for tics (CBIT) to treat children and/or adults with tic disorders falls within their scope of practice according to state licensing laws and regulations in the therapist's jurisdiction.
. Have never attended the Tourette Association of America's Behavior Therapy Training Institute or an equivalent focused on CBIT.
. Have access to a secure personal computer with high-speed internet access.
. Speaks fluent English.
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
Therapist scores on the CBIT Fidelity Checklist and Rating Scale at post-training
Timeframe: up to 2 weeks post-training
2
Therapist scores on the CBIT Fidelity Checklist and Rating Scale at post-treatment
Timeframe: 10-12 weeks post-training
3
Therapist scores on the CBIT Fidelity Checklist & Rating Scale at 6-month follow-up
Timeframe: 24-26 weeks post-training
4
Proportion of treatment responders at post-treatment on the Clinical Global Impression Improvement Scale (CGI-I)
Timeframe: 10-12 weeks from the start of treatment (post-treatment)
5
Proportion of treatment responders at follow-up on the Clinical Global Impression Improvement Scale (CGI-I)
Timeframe: 24-26 weeks from the start of treatment (6-month follow-up)
6
Patient changes in overall symptom severity on the Clinical Global Impression Severity Scale (CGI-S)
Timeframe: Up to 2 weeks prior to starting treatment (baseline), 10-12 weeks from the start of treatment (post-treatment), 24-26 weeks from the start of treatment (6-month follow-up)
. Has identified, or is willing to try to identify, at least 1 child or adult patient with a tic disorder who meets the patient inclusion criteria and who might be willing to participate in the study as a member of the therapist-patient dyad, and for whom the therapist is licensed or certified to treat with CBIT according to state licensing laws and regulations in the therapist's jurisdiction.
. Is willing to be randomly assigned to training condition.
Exclusion criteria
. 7 years of age or older (with consenting adult for minors).
. Self- or parent-reported diagnosis of a tic disorder (e.g., provisional tic disorder, persistent motor/vocal tic disorder, or Tourette's disorder) issued by a qualified professional.
. Currently engages in at least one motor and/or vocal tic multiple times per day.
. Patient (and consenting adult for minors) speaks fluent English.
. Access to a private computer with high-speed internet access.
. Patients will be excluded if the study team is unable to identify and enroll a patient-matched therapist who meets the therapist inclusion criteria.
. Patient is a first, second, or third degree biological relative of the study-matched therapist or if the study-matched therapist is the patient's legal guardian.
. Any serious psychiatric or neurological condition that requires more immediate intervention or would interfere with study participation, based on the assessment of the treating therapist or the study investigators.