NCT03765463

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

February 28, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2023

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

3.9 years

First QC Date

December 4, 2018

Last Update Submit

August 4, 2023

Conditions

Keywords

Extinction learningBehavior TherapyTourette's DisorderHabit Reversal TrainingComprehensive Behavioral Intervention for Tics

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 1 week after completion of HRT

Secondary Outcomes (1)

  • Tic severity as assessed by the Yale Global Tic Severity Scale-Revised (YGTSS)

    Within 1 week after completion of HRT

Study Arms (1)

Habit Reversal Training

EXPERIMENTAL

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

Interventions

4 sessions of habit reversal training

Habit Reversal Training

Eligibility Criteria

Age8 Years - 17 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • An inability to complete rating scales
  • Attend study visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

TicsTourette Syndrome

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental Disorders

Study Officials

  • Joseph F McGuire, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2018

First Posted

December 5, 2018

Study Start

February 28, 2019

Primary Completion

February 1, 2023

Study Completion

August 2, 2023

Last Updated

August 8, 2023

Record last verified: 2023-08

Locations