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Online-Delivered Comprehensive Behavioral Intervention for Tics-Enhanced (CBIT-E)

Primary Purpose

Persistent Tic Disorders, Tourette Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Behavioral Intervention for Tics - Enhanced (CBIT-E)
Sponsored by
Marquette University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Tic Disorders focused on measuring Persistent Tic Disorders, Tourette Disorder, Tics, Behavior Therapy, Children

Eligibility Criteria

9 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ages 9-17
  • meets Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for TD or PTD
  • at screening visit, a Parent Tic Questionnaire (PTQ) total score > 18 and < 60 OR > 12 and < 40 if persistent tic disorder (for total scores > 60 on the PTQ, the research team will examine the patient's global functioning to determine participation appropriateness. The research team will consider if other treatments, such as medication, may be more appropriate for participants with PTQ total scores > 60. If the participant is already taking tic medication, or tic medication has been unsuccessful in the past, then he/she may be considered for the study)
  • at baseline visit, a Yale Global Tic Severity Score (YGTSS Total Score) > 14 and < 30 OR > 10 and < 20 if persistent tic disorder (for total scores > 30 on the YGTSS, the research team will examine the patient's global functioning to determine participation appropriateness)
  • no history of behavioral treatment for tics, including self-guided therapy programs for tics
  • unmedicated or on stable medication for tics and other psychiatric disorder for at least 6 weeks, with no planned changes during study participation
  • access to a personal computer (desktop or laptop) with a camera
  • access to an Internet connection with a minimum speed of 5 megabytes per second (Mbps)
  • fluent English speaker.

Exclusion Criteria:

  • co-occurring disorders that require more immediate treatment or change to current treatment
  • T-Score < 37 on the Wechsler Abbreviated Scale of Intelligence (WASI) - Vocabulary subtest
  • T-Score > 70 on the inattention or hyperactivity/impulsivity scales of the Conners 3-Parent Short (C 3-PS).

Sites / Locations

  • Marquette UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CBIT-E

Waitlist Control (WLC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 3, 2021
Last Updated
October 2, 2021
Sponsor
Marquette University
Collaborators
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT05050734
Brief Title
Online-Delivered Comprehensive Behavioral Intervention for Tics-Enhanced (CBIT-E)
Official Title
A Randomized Waitlist-Controlled Pilot Trial of Online-Delivered Comprehensive Behavioral Intervention for Tics-Enhanced (CBIT-E)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marquette University
Collaborators
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Tic Disorders, Tourette Disorder
Keywords
Persistent Tic Disorders, Tourette Disorder, Tics, Behavior Therapy, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBIT-E
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control (WLC)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Behavioral Intervention for Tics - Enhanced (CBIT-E)
Intervention Description
Behavioral treatment for persistent tic disorders.
Primary Outcome Measure Information:
Title
Yale Global Tic Severity Scale (YGTSS)
Description
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)
Secondary Outcome Measure Information:
Title
Clinical Global Impression-Improvement (CGI-I) Scale
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ages 9-17 meets Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for TD or PTD at screening visit, a Parent Tic Questionnaire (PTQ) total score > 18 and < 60 OR > 12 and < 40 if persistent tic disorder (for total scores > 60 on the PTQ, the research team will examine the patient's global functioning to determine participation appropriateness. The research team will consider if other treatments, such as medication, may be more appropriate for participants with PTQ total scores > 60. If the participant is already taking tic medication, or tic medication has been unsuccessful in the past, then he/she may be considered for the study) at baseline visit, a Yale Global Tic Severity Score (YGTSS Total Score) > 14 and < 30 OR > 10 and < 20 if persistent tic disorder (for total scores > 30 on the YGTSS, the research team will examine the patient's global functioning to determine participation appropriateness) no history of behavioral treatment for tics, including self-guided therapy programs for tics unmedicated or on stable medication for tics and other psychiatric disorder for at least 6 weeks, with no planned changes during study participation access to a personal computer (desktop or laptop) with a camera access to an Internet connection with a minimum speed of 5 megabytes per second (Mbps) fluent English speaker. Exclusion Criteria: co-occurring disorders that require more immediate treatment or change to current treatment T-Score < 37 on the Wechsler Abbreviated Scale of Intelligence (WASI) - Vocabulary subtest T-Score > 70 on the inattention or hyperactivity/impulsivity scales of the Conners 3-Parent Short (C 3-PS).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan T Stiede, M.S.
Phone
414-288-6177
Email
jordan.stiede@marquette.edu
Facility Information:
Facility Name
Marquette University
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan T. Stiede, M.S.
Phone
414-288-6177
Email
jordan.stiede@marquette.edu

12. IPD Sharing Statement

Learn more about this trial

Online-Delivered Comprehensive Behavioral Intervention for Tics-Enhanced (CBIT-E)

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