Clinical trial NCT05050734: Online-Delivered Comprehensive Behavioral Intervention for Tics-Enhanced (CBIT-E)
Official title: A Randomized Waitlist-Controlled Pilot Trial of Online-Delivered Comprehensive Behavioral Intervention for Tics-Enhanced (CBIT-E)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Tic Disorders
Tourette Disorder
Keywords: Persistent Tic Disorders
Tourette Disorder
Tics
Behavior Therapy
Children
Lead sponsor: Marquette University
Sponsor class: OTHER
Collaborators: name: University of Utah
First posted: 2021-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot trial is to examine the preliminary efficacy of online-delivered Comprehensive Behavioral Intervention for Tics - Enhanced (CBIT-E). In the study, 30 children with persistent tic disorders (PTDs) will be recruited via information provided to patients of the Marquette University (MU) Tic Disorders Specialty Clinic (TDSC) and information conveyed via local medical health professionals, with the goal of randomizing 10 participants to each group. For those randomized to CBIT-E, treatment will be administered according to the standard CBIT manual, but there will be two modifications. CBIT typically consists of the implementation of strategies to help manage the environment related to tics and the implementation of an exercise to engage in when an individual feels the urge to tic. CBIT-E will include these same techniques, plus additional in-session and out of session practice of the exercises, called competing responses, that individuals use when they feel the urge to tic. Treatment will be delivered over Microsoft Teams, which is a secure video conferencing system. The therapist will administer treatment from a private room in the Marquette University Tic Disorder Specialty Clinic, while the parent and child will be at their home. Treatment will include a screening visit, baseline assessment, 11 weeks (9 sessions) of CBIT-E, a post treatment assessment, and a three-month follow up assessment. Further, starting after session 3, there will be four 15-minute practice periods scheduled each week between sessions. During these practice periods, the child and therapist will meet over Microsoft Teams and the therapist will administer an enhanced reward task.

Children randomized to the waitlist control (WLC) will not receive treatment during the 11-week period. Instead, they will be placed on a waitlist to receive standard CBIT following the end of the study period. Participants in this group will complete a screening visit, baseline assessment, and a final assessment, which will occur approximately 11 weeks after baseline.


Eligibility criteria: Inclusion Criteria:

* ages 9-17
* meets Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for TD or PTD
* at screening visit, a Parent Tic Questionnaire (PTQ) total score \> 18 and \< 60 OR \> 12 and \< 40 if persistent tic disorder (for total scores \> 60 on the PTQ, the research team will examine the patient's global functioning to determine participation appropriateness. The research team will consider if other treatments, such as medication, may be more appropriate for participants with PTQ total scores \> 60. If the participant is already taking tic medication, or tic medication has been unsuccessful in the past, then he/she may be considered for the study)
* at baseline visit, a Yale Global Tic Severity Score (YGTSS Total Score) \> 14 and \< 30 OR \> 10 and \< 20 if persistent tic disorder (for total scores \> 30 on the YGTSS, the research team will examine the patient's global functioning to determine participation appropriateness)
* no history of behavioral treatment for tics, including self-guided therapy programs for tics
* unmedicated or on stable medication for tics and other psychiatric disorder for at least 6 weeks, with no planned changes during study participation
* access to a personal computer (desktop or laptop) with a camera
* access to an Internet connection with a minimum speed of 5 megabytes per second (Mbps)
* fluent English speaker.

Exclusion Criteria:

* co-occurring disorders that require more immediate treatment or change to current treatment
* T-Score \< 37 on the Wechsler Abbreviated Scale of Intelligence (WASI) - Vocabulary subtest
* T-Score \> 70 on the inattention or hyperactivity/impulsivity scales of the Conners 3-Parent Short (C 3-PS).

Primary outcomes:
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: Change from baseline at post-treatment (11 weeks after baseline) and change from post at follow-up (3 months after post)
Secondary outcomes:
measure: Clinical Global Impression-Improvement (CGI-I) Scale
timeFrame: Will be completed by the independent evaluator at post (11 weeks after baseline) and 3-month follow-up (3 months after post)
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Marquette University
state: Wisconsin
Study officials:
References: