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Recruiting NCT05370391

Comprehensive Behavioral Intervention for Tics

No phase Interventional Tic Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Comprehensive Behavioral Intervention for Tics (CBIT).
Who it may be relevant to
Registry conditions: Tic Disorders. Basic parameters: 5 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comprehensive Behavioral Intervention for Tics (CBIT) for Youth With Tics and Related Emotional Disorders

Overview

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.

Interventions

  • Behavioral Comprehensive Behavioral Intervention for Tics (CBIT)
    The CBIT (or CBIT-JR) intervention consists of a minimum of 6 sessions of 50-minutes each week in an individual or group setting.

Primary outcome measures

  • Clinical Global Impression (CGI) - Severity Scale Scores [Time frame: Change from baseline CGI-S scores to 12 weeks.]
  • Clinical Global Impression (CGI) - Improvement Scores [Time frame: Change from baseline CGI-I scores to 12 weeks from the start of treatment.]
  • Parent Tic Questionnaire (PTQ) [Time frame: Change from pre-screen PTQ scores, to baseline, to 6 weeks, and 12 weeks from the start of treatment.]
  • Premonitory Urge Tic Scale (PUTS) [Time frame: Change from baseline PUTS scores, to 6 weeks, to 12 weeks from the start of treatment.]
  • Youth Quality of Life (YQOL) Instrument - Short Form (SF) Scores [Time frame: Change from baseline YQOL Scores, to 6 weeks, to 12 weeks from the start of treatment.]
  • Yale Global Tic Severity Scale (YGTSS) - Total Tic Scores [Time frame: Change from pre-screen YGTSS Total Tic Scores, to 6 weeks, and 12 weeks from the start of treatment.]
  • Yale Global Tic Severity Scale (YGTSS) - Total Motor Tic Scores [Time frame: Change from pre-screen YGTSS Total Motor Tic Scores, to 6 weeks, and 12 weeks from the start of treatment.]
  • Yale Global Tic Severity Scale (YGTSS) - Total Phonic Tic Score [Time frame: Change from pre-screen YGTSS Total Phonic Tic Scores, to 6 weeks, and 12 weeks from the start of treatment.]
  • Yale Global Tic Severity Scale (YGTSS) - Overall Tic Related Impairment Scores [Time frame: Change from YGTSS Overall Tic Related Impairment Scores pre-screen, to 6 weeks, and 12 weeks from the start of treatment.]
  • Yale Global Tic Severity Scale (YGTSS) - Global Severity Score [Time frame: Change from pre-screen YGTSS Global Severity Score, to 6 weeks, and 12 weeks from the start of treatment.]
Secondary outcome measures (2)
  • Revised Children's Anxiety and Depression Scale - Child and Revised Parent Short (RCADS-25/RCADS-P-25) Scores [Time frame: Change from baseline RCADS-P scores, to 6 weeks, to 12 weeks from the start of treatment.]
  • Tic Accommodation and Reactions Scale (TARS) Scores [Time frame: Change from baseline TARS scores, to 6 weeks, to 12 weeks from the start of treatment.]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami — Coral Gables

Identifiers

NCT: NCT05370391 · 20210853

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗