Recruiting

Observational Study

Sponsor:

University of Utah

Code:

NCT06385535

Conditions

Tics

Tic Disorders

Vocal Tic

Motor Tic

Tourette Syndrome

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Not accepted

Interventions

Habit Reversal Training (HRT)

Study Details

Brief summary:

The goal of this clinical study is to learn more about the timing of tics (sudden, fast movements and sounds that people do and make without meaning to) in people who have multiple tics that have been going on for more than one year. The main questions it aims to answer are:

1. See whether a tic's timing is related to other characteristics of the tic, like how long it has been happening and how well the person can control/stop that tic
2. See whether the timing of a tic can tell us how well the person can control/stop that tic
3. See whether tic treatment changes the timing of tics, and if the timing of a tic has anything to do with how well treatment will work to stop it

Participants will meet with a study researcher to learn more about the study, ask questions, and decide whether or not they would like to be involved. If they decide to do the study, they will meet with the researcher 6 times:

1. During the first visit, the study researcher will ask questions about the participant's life, tics, and other psychological symptoms. The researcher will watch the participant's tics for 10 minutes. The participant will do a computer task where they follow instructions to tic or not tic.
2. During the second visit, the study researcher will treat one of the participant's tics.
3. During the third visit, the study researcher will treat another one of the participant's tics.
4. During the fourth visit, the study researcher will treat another one of the participant's tics.
5. During the fifth visit, the study researcher will treat another one of the participant's tics.
6. During the sixth visit, the study researcher will ask questions about the participant's tics and other psychological symptoms. The participant will do a computer task where they follow instructions to tic or not tic.

Conditions

Tics

Tic Disorders

Vocal Tic

Motor Tic

Tourette Syndrome

Study ID

NCT06385535

Start date

Apr 4, 2024

Status verified date

Apr, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 8 to 12 years old child who meets the criteria for diagnosis of a persistent tic disorder (e.g., persistent motor/vocal tic disorder or Tourette's disorder; i.e., engages in motor and/or vocal tics that have been present for at least one year)
  • The child's tics initially onset before age 10.
  • The child currently engages in at least four different motor and/or vocal tics per minute, on average, during a 10-minute observation period.
  • The child has a minimum Total Tic Severity Score of 20 on the Yale Global Tic Severity Scale (10 for motor or vocal tics only)
  • If the child is on tic-suppressing or psychotropic medication, the dose has been stable for at least 6 weeks with no changes or planned changes in medication status during the study period.
  • Parent and child read and speak fluent English.
  • The parent is 18+ years of age.
  • Access to a private computer with high-speed internet access and private setting.

Exclusion Criteria:

  • If, based on the assessment of the study investigators, the child has any serious psychiatric or neurological condition that would interfere with study participation (e.g., unmanaged attention-deficit hyperactivity disorder)
  • The child has a self- or parent-reported history of, or is reasonably suspected to have or meet criteria for, functional neurological symptom disorder.
  • The child has received more than two sessions of behavioral treatment for tics for which tic suppression was a primary component.
  • The child has a Total Tic Severity Score of 40+ on the Yale Global Tic Severity Scale (20+ for motor/vocal tics only).

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Habit Reversal Training (HRT)

All participants receive 4 sessions of HRT (Habit Reversal Training) to treat their tics.

Interventions

Habit Reversal Training (HRT)

Habit Reversal Training (HRT) is a multicomponent treatment package developed to treat a repetitive behaviors. HRT includes (1) increasing awareness of discrete occurrences of tics and associated premonitory urges (PMUs; i.e., awareness training), (2) teaching the patient to suppress tics by engaging in behaviors that are physically incompatible with target tics (i.e., competing response \[CR\] training), and (3) prompting and reinforcing between-session patient engagement with therapeutic techniques and homework (i.e., providing social support).

Primary outcome measure

  • Estimates of baseline individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies [ Time Frame: Pre-intervention (baseline) ]
  • Voluntary tic suppression success at baseline [ Time Frame: Pre-intervention (baseline) ]
  • Total tic severity at baseline as measured by the Yale Global Tic Severity Scale (YGTSS) [ Time Frame: Pre-intervention (baseline) ]
  • Total and individual tic severity at baseline as measured by the Parent Tic Questionnaire (PTQ) [ Time Frame: Pre-intervention (baseline) ]
  • Changes in voluntary individual and total tic suppression success pre- and post-intervention [ Time Frame: Pre-intervention (baseline), up to 1 week post intervention ]
  • Changes in individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies pre- and post-intervention [ Time Frame: Pre-intervention (baseline), up to 1 week post intervention ]
  • Changes in individual and total tic severity pre- and post-intervention as measured by the Yale Global Tic Severity Scale (YGTSS) and Parent Tic Questionnaire (PTQ) [ Time Frame: Pre-intervention (baseline), up to 1 week post intervention ]

Central Contacts and Locations

Central contacts

Kirsten Bootes, MS

801-585-7114kirsten.bootes@psych.utah.edu

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Kirsten Bootes, MS

801-585-7114kirsten.bootes@psych.utah.edu

Kirsten Bootes, MS

theticlab@utah.edu

More Information

Sponsor

University of Utah

Last update posted

Apr 26, 2024

Last verified

Apr, 2024

Keywords

  • Tics
  • Tic Disorders
  • Vocal Tic
  • Motor Tic
  • Tourette Syndrome
  • Tourette Syndrome in Children
  • Tourette Syndrome in Adolescence
  • Tics/Tremor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2024-04-26.