An interventional study of Comprehensive Behavioral Intervention for Tics - Enhanced (CBIT-E) in Persistent Tic Disorders and Tourette Disorder, sponsored by Marquette University. Status unknown at 1 site in United States. Open to participants aged 9 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-10-08.
Sponsored by Marquette University · Not applicable, Interventional, and Treatment
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.
240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.
This study's planned enrollment of 30 is below the median of 36 across 183 interventional studies indexed under Tourette Syndrome.
Browse Tourette Syndrome studies →Marquette University is the lead sponsor of 38 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
For those randomized to CBIT-E, treatment will be administered according to the standard CBIT manual, which includes psychoeducation, functional assessment/interventions, habit reversal training, relaxation techniques, and a motivational reward program. However, there will be two modifications. CBIT-E will include additional in-session and out of session practice of exercises, called competing response. 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.
Behavioral: Comprehensive Behavioral Intervention for Tics - Enhanced (CBIT-E)
These participants 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. The final assessment will be approximately 11 weeks after baseline.
Behavioral treatment for persistent tic disorders.
Yale 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)
Started Sep 2021 (actual). Primary completion is estimated for Sep 2022, 11 months after the start.
Of 65 non-industry interventional studies with no phase under Tourette Syndrome, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 50. This study's planned 11 months is below that.
Counting every sponsor, half of 65 studies reached it within 33 months; a quarter within 22 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Marquette University