Extinction Learning in Youth With Tourette Syndrome

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03765463

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tourette Syndrome in Children Tourette Syndrome in Adolescence Habit Reversal Training Tic	Behavioral: Habit Reversal Training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Extinction Learning in Youth With Tourette Syndrome

Actual Study Start Date :

Feb 28, 2019

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Habit Reversal Training 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.	Behavioral: Habit Reversal Training 4 sessions of habit reversal training

Arm

Intervention/Treatment

Experimental: Habit Reversal Training

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.

Behavioral: Habit Reversal Training

4 sessions of habit reversal training

Outcome Measures

Primary Outcome Measures

Tic severity as assessed by the Hopkins Motor and Vocal Tic Scale (HM/VTS) [Within 1 week after completion of HRT]
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) [Within 1 week after completion of HRT]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.