Clinical trial NCT05370391: Comprehensive Behavioral Intervention for Tics
Official title: Comprehensive Behavioral Intervention for Tics (CBIT) for Youth with Tics and Related Emotional Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tic Disorders
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 200
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: Inclusion criteria

* 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.

Exclusion criteria

* 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).

Primary outcomes:
measure: Clinical Global Impression (CGI) - Severity Scale Scores
timeFrame: Change from baseline CGI-S scores to 12 weeks.
measure: Clinical Global Impression (CGI) - Improvement Scores
timeFrame: Change from baseline CGI-I scores to 12 weeks from the start of treatment.
measure: Parent Tic Questionnaire (PTQ)
timeFrame: Change from pre-screen PTQ scores, to baseline, to 6 weeks, and 12 weeks from the start of treatment.
measure: Premonitory Urge Tic Scale (PUTS)
timeFrame: Change from baseline PUTS scores, to 6 weeks, to 12 weeks from the start of treatment.
measure: Youth Quality of Life (YQOL) Instrument - Short Form (SF) Scores
timeFrame: Change from baseline YQOL Scores, to 6 weeks, to 12 weeks from the start of treatment.
measure: Yale Global Tic Severity Scale (YGTSS) - Total Tic Scores
timeFrame: Change from pre-screen YGTSS Total Tic Scores, to 6 weeks, and 12 weeks from the start of treatment.
measure: Yale Global Tic Severity Scale (YGTSS) - Total Motor Tic Scores
timeFrame: Change from pre-screen YGTSS Total Motor Tic Scores, to 6 weeks, and 12 weeks from the start of treatment.
measure: Yale Global Tic Severity Scale (YGTSS) - Total Phonic Tic Score
timeFrame: Change from pre-screen YGTSS Total Phonic Tic Scores, to 6 weeks, and 12 weeks from the start of treatment.
measure: Yale Global Tic Severity Scale (YGTSS) - Overall Tic Related Impairment Scores
timeFrame: Change from YGTSS Overall Tic Related Impairment Scores pre-screen, to 6 weeks, and 12 weeks from the start of treatment.
measure: Yale Global Tic Severity Scale (YGTSS) - Global Severity Score
timeFrame: Change from pre-screen YGTSS Global Severity Score, to 6 weeks, and 12 weeks from the start of treatment.
Secondary outcomes:
measure: Revised Children's Anxiety and Depression Scale - Child and Revised Parent Short (RCADS-25/RCADS-P-25) Scores
timeFrame: Change from baseline RCADS-P scores, to 6 weeks, to 12 weeks from the start of treatment.
measure: Tic Accommodation and Reactions Scale (TARS) Scores
timeFrame: Change from baseline TARS scores, to 6 weeks, to 12 weeks from the start of treatment.
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Jill Ehrenreich-May, Ph.D.
role: STUDY_DIRECTOR
References: