Back to resultsExtinction Learning in Youth With Tourette Syndrome
Primary Purpose
Tourette Syndrome in Children, Tourette Syndrome in Adolescence, Habit Reversal Training
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Habit Reversal Training
Sponsored by
About this trial
This is an interventional treatment trial for Tourette Syndrome in Children focused on measuring Extinction learning, Behavior Therapy, Tourette's Disorder, Habit Reversal Training, Comprehensive Behavioral Intervention for Tics
Eligibility Criteria
Youth with TS will be eligible for participation if they meet the following inclusion criteria:
- age 8-17 years (inclusive)
- have moderate tic severity or greater as evidenced by a YGTSS Total Tic Score greater than 13 (>9 for youth with motor or vocal tics only)
- have not received more than 4 previous sessions of HRT
- be fluent in English.
- Medication free or on a stable dose of psychiatric medication for 8 weeks prior to enrollment.
Exclusion criteria for youth with TS:
- An inability to complete rating scales
- Attend study visits.
Sites / Locations
- Johns Hopkins University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Habit Reversal Training
Arm Description
Habit Reversal Training (HRT) is a multi-component evidence-based treatment for tics. It will be delivered over 4 two-hour sessions in an intensive format.
Outcomes
Primary Outcome Measures
Tic severity as assessed by the Hopkins Motor and Vocal Tic Scale (HM/VTS)
Patient will nominate up to five motor and five vocal tics they deem bothersome on the HM/VTS. Each bothersome tic is then rated by a clinician on the composite two (vocal and motor) 5-point HM/VTS scale ranging from none (0) to severe (4) for the motor as well as vocal tics. The individual tic scores are summed (minimum of 0 and maximum of 40) and averaged together to create an average tic severity score.
Secondary Outcome Measures
Tic severity as assessed by the Yale Global Tic Severity Scale-Revised (YGTSS)
The YGTSS is a clinician-rated semi-structured interview that measures tic symptom severity over the previous week. It consists of 10-items that assess different dimensions of tic severity for motor and vocal tics, which are rated on a 0-5 scale. The YGTSS produces a Total Tic Score (range: 0-50), with higher ratings indicating greater tic severity. The YGTSS has demonstrated treatment sensitivity to pharmacotherapy and behavioral interventions.
Full Information
NCT ID
NCT03765463
First Posted
December 4, 2018
Last Updated
August 4, 2023
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT03765463
Brief Title
Extinction Learning in Youth With Tourette Syndrome
Official Title
Extinction Learning in Youth With Tourette Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
August 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
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
Aversive sensory phenomena such as premonitory urges play a central role in the behavioral treatment model of tics. Extinction learning and extinction recall are learning processes implicated within this model, but have not been directly evaluated in youth with Tourette syndrome (TS). This study examines extinction learning and extinction recall in youth with TS using an experimental task. This study will also explore the relationship between extinction processes (i.e., extinction learning and extinction recall) and treatment outcomes with behavior therapy. Findings from this investigation will be used to update the behavioral treatment model, which serves as the basis for evidence-based behavioral interventions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome in Children, Tourette Syndrome in Adolescence, Habit Reversal Training, Tic
Keywords
Extinction learning, Behavior Therapy, Tourette's Disorder, Habit Reversal Training, Comprehensive Behavioral Intervention for Tics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Habit Reversal Training
Arm Type
Experimental
Arm Description
Habit Reversal Training (HRT) is a multi-component evidence-based treatment for tics. It will be delivered over 4 two-hour sessions in an intensive format.
Intervention Type
Behavioral
Intervention Name(s)
Habit Reversal Training
Intervention Description
4 sessions of habit reversal training
Primary Outcome Measure Information:
Title
Tic severity as assessed by the Hopkins Motor and Vocal Tic Scale (HM/VTS)
Description
Patient will nominate up to five motor and five vocal tics they deem bothersome on the HM/VTS. Each bothersome tic is then rated by a clinician on the composite two (vocal and motor) 5-point HM/VTS scale ranging from none (0) to severe (4) for the motor as well as vocal tics. The individual tic scores are summed (minimum of 0 and maximum of 40) and averaged together to create an average tic severity score.
Time Frame
Within 1 week after completion of HRT
Secondary Outcome Measure Information:
Title
Tic severity as assessed by the Yale Global Tic Severity Scale-Revised (YGTSS)
Description
The YGTSS is a clinician-rated semi-structured interview that measures tic symptom severity over the previous week. It consists of 10-items that assess different dimensions of tic severity for motor and vocal tics, which are rated on a 0-5 scale. The YGTSS produces a Total Tic Score (range: 0-50), with higher ratings indicating greater tic severity. The YGTSS has demonstrated treatment sensitivity to pharmacotherapy and behavioral interventions.
Time Frame
Within 1 week after completion of HRT
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Youth with TS will be eligible for participation if they meet the following inclusion criteria:
age 8-17 years (inclusive)
have moderate tic severity or greater as evidenced by a YGTSS Total Tic Score greater than 13 (>9 for youth with motor or vocal tics only)
have not received more than 4 previous sessions of HRT
be fluent in English.
Medication free or on a stable dose of psychiatric medication for 8 weeks prior to enrollment.
Exclusion criteria for youth with TS:
An inability to complete rating scales
Attend study visits.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph F McGuire, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Extinction Learning in Youth With Tourette Syndrome
We'll reach out to this number within 24 hrs