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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Behavioral treatment for persistent tic disorders.
Marquette University
Milwaukee, Wisconsin, United States
RECRUITINGYale Global Tic Severity Scale (YGTSS)
Clinician-rated measure that assesses motor and vocal tic severity and impairment over the past week. Motor and vocal tic number, frequency, intensity, complexity, and interference are rated on a 0-5 scale and summed to create separate motor and vocal tic severity scores (each ranging from 0-25). These ratings are combined to create a total tic severity score (Range = 0-50). Clinicians also rate overall tic-related impairment on a 50-point scale. Higher scores are related to more tic severity/impairment.
Time frame: Change from baseline at post-treatment (11 weeks after baseline) and change from post at follow-up (3 months after post)
Clinical Global Impression-Improvement (CGI-I) Scale
Clinician-rated scale used to assess overall treatment response. Ratings on the CGI-I range from 1 (very much improved) to 8 (very much worse). CGI-I scores of 2 (much improved) or 1 (very much improved) indicate positive treatment response. Higher scores are related to worse treatment response.
Time frame: Will be completed by the independent evaluator at post (11 weeks after baseline) and 3-month follow-up (3 months after post)
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