Incorporating teleCBIT Into a Hospital-Based Tic Program

Study Overview
=================
Brief Summary
-----------------
This is a single-arm open trial of Comprehensive Behavioral Intervention for Tics (CBIT) delivered to pediatric and adult patients with persistent tic disorders in their homes via videoconferencing (i.e., teleCBIT). All participants who enroll will receive teleCBIT.

Detailed Description
-----------------
Comprehensive Behavioral Intervention for Tics (CBIT) is a behavioral therapy with proven efficacy for treating persistent tic disorders (e.g., Tourette Syndrome) in youth and adults. Lack of access to a local CBIT provider prevents treatment access for many patients who could benefit from CBIT. Providing CBIT to patients in their homes via videoconferencing technology (i.e., teleCBIT) is a promising approach to increasing CBIT access. This study investigates treatment uptake, acceptability, feasibility, and clinical effectiveness of teleCBIT among pediatric and adult patients enrolled as patients in a state-of-the-art medical tic program.

Official Title
-----------------
Incorporating teleCBIT Into a Hospital-Based Tic Program

Conditions
-----------------
Tic Disorders, Tourette Syndrome

Intervention / Treatment
-----------------
* Behavioral: teleCBIT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 5-65, diagnosis of Tourette Syndrome or other persistent tic disorder (per diagnostic interview and self-report of prior physician diagnosis) Clinical Global Impressions - Severity Score > 3 (i.e., moderately ill or worse), unmedicated or on stable medication treatment for tics and psychiatric problems, fluency in English a functional accessible home computer and high speed (i.e., cable/DSL) internet connection willingness to sign a release of information to contact a local, licensed medical or mental health provider, of whom they are currently a patient (in case of emergent safety concerns). Minor participants must have a parent or guardian who is fluent in English available to attend treatment and assessment sessions. Exclusion Criteria: significant suicidality, (i.e., a score of > 12 on the MINI or MINI-Kid suicidality module); prior diagnoses of intellectual disability; pervasive developmental disorder, mania, schizophrenia, psychotic disorder, substance abuse, substance dependence, or conduct disorder; currently experiencing a psychosocial, psychiatric, or neurological problem that requires immediate care lack of a functional home computer with high speed (i.e., cable or DSL) internet connection; or, prior receipt of >3 previous sessions of behavior therapy for tics within the past year (per self/parent report)

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: teleCBIT<br>Patient receive eight sessions of individual teleCBIT, in accordance with Woods et al's (2008) protocol, from a licensed psychologist. | Behavioral: teleCBIT<br>* Eight sessions of individual behavior therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Yale Global Tic Severity Scale Tic Severity Score (YGTSS) | YGTSS Tic Severity Score (0-50) as rated by independent evaluator. Higher scores indicate more severe tics. | Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression: Improvement (CGI:I) Score | CGI:I scores (range: 1-7) describe the global level of change in clinical severity of a disorder. Lower scores indicate more favorable change over time. Following common practice, we will also dichotomize CGI:I scores to evaluate Clinical Responder Status according to CGI:I score (i.e., responder: CGI:I=1 or 2; non-responder=CGI:I>2) | CGI:I score at post-treatment (Week 10), which assesses change from pre-treatment (i.e., week 0) | 
| Parent Tic Questionnaire (PTQ) Total Tic Severity Score | Child Tic Severity as measured by parent-report on the PTQ (range: 0-224). Higher scores indicate more severe tics. | Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week) | 
| Adult Tic Questionnaire (ATQ) Total Tic Severity Score | Adult Tic Severity as measured by self-report on the ATQ (range: 0-224). Higher scores indicate more severe tics. | Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week) | 
| Yale Global Tic Severity Scale (YGTSS) Impairment Score | YGTSS Impairment Score (0-50) as rated by independent evaluator. Higher scores indicate greater tic-related impairment | Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week) |