Comprehensive Behavioral Intervention for Tics
ConditionTic Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorUniversity of Miami
About this trial
The purpose of this protocol is to examine treatment outcomes of youth receiving the Comprehensive Behavioral Intervention for Tics (CBIT) and better understand the predictors, moderators, mediators and/or mechanisms of change for this intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A current diagnosis of a Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Tic disorder (e.g., Tourette's Disorder/syndrome, Persistent (Chronic) Motor or Vocal Tic Disorder, or Provisional Tic Disorder) or caregiver/youth report of clinically impairing tic symptoms
Ability for youth to speak/read English sufficiently
At least one parent/caregiver available to sign study consent forms, remain present during assessments, and fill out study questionnaires in English.
Disqualifiers
A current diagnosis of psychosis, bipolar disorder, intellectual disability, acute suicidality, alcohol/substance dependence, or eating disorder.
Youth currently receiving psychotherapy elsewhere and/or have previously received CBIT.
Currently suicidal or who have engaged in suicidal behaviors within the past 6 months will be excluded
Youth currently taking psychotropic medication for a co-morbid psychiatric illness will be included without a wash-out period (to not delay treatment).
Trial design
Design model
Single group
Treatments tested in this trial
Comprehensive Behavioral Intervention for Tics (CBIT)
BehavioralThe CBIT (or CBIT-JR) intervention consists of a minimum of 6 sessions of 50-minutes each week in an individual or group setting.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Comprehensive Behavioral Intervention for Tics (CBIT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinical Global Impression (CGI) - Severity Scale Scores
A single-item clinician-reported measure used to assess the severity of the youth's illness at the time of assessment. The CGI-S is rated on a 7-point scale ranging from 1 (slight psychiatric illness) to 7 (extremely severe psychiatric illness). Higher scores indicate greater symptom severity.
Time frame
Change from baseline CGI-S scores to 12 weeks.2
Clinical Global Impression (CGI) - Improvement Scores
A single-item clinician-reported measure used to assess clinical changes in youth symptomology over the course of treatment. The CGI-I is rated on a 7-point scale ranging from 1 (very much improved since the initiation of treatment) to 7 (very much worse since the initiation of treatment). Higher scores indicate greater symptom improvement since baseline
Time frame
Change from baseline CGI-I scores to 12 weeks from the start of treatment.3
Parent Tic Questionnaire (PTQ)
A 28-item parent-reported measure used to assess the frequency and intensity of different motor and vocal tic symptoms in youth. The PTQ evaluates tic frequency on a 4-point scale, ranging from 1 (constant) to 4 (weekly), and intensity on a 3-point scale, ranging from 1 (mild) to 3 (very noticeable). This is done for each presenting tic. Composite total scores on the PTQ range from 2-138. Higher summed composite score indicating more tics.
Time frame
Change from pre-screen PTQ scores, to baseline, to 6 weeks, and 12 weeks from the start of treatment.4
Premonitory Urge Tic Scale (PUTS)
A 10-item self-reported measure that assess the severity of premonitory urges. The PUTS is rated on a 4-point scale ranging from 1 (not at all true) to 4 (very much true). Total scores range from 10-40 with higher scores indicating greater symptom severity.
Time frame
Change from baseline PUTS scores, to 6 weeks, to 12 weeks from the start of treatment.Secondary outcomes
1
Revised Children's Anxiety and Depression Scale - Child and Revised Parent Short (RCADS-25/RCADS-P-25) Scores
A 25-item self- and parent-reported scales measuring symptoms of anxiety and depression in youth. Items are rated on a 4-point scale from 1 (Never) to 4 (always) with scores ranging from 0 to 75. A score of 70 or higher indicates high severity, above clinical threshold.
Time frame
Change from baseline RCADS-P scores, to 6 weeks, to 12 weeks from the start of treatment.2
Tic Accommodation and Reactions Scale (TARS) Scores
A 35-item parent-reported measure used to assess reactions and consequences that occur in response to youth' tics. Items focus on events at home, in school, and in other public places. The TARS is rated on a 4-point scale from 0 (not at all in the past week) to 3 (many times in the past week). Scores range from 0 to 105, with higher scores indicating greater frequency of reaction and consequences in response to their child's tics.
Time frame
Change from baseline TARS scores, to 6 weeks, to 12 weeks from the start of treatment.Sponsors and contacts
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Source ClinicalTrials.gov