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NCT Number: NCT06194305

Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics

Tourette Syndrome and Persistent Motor/Vocal Tic Disorder affect 1-3% of youth and can be associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, and peer victimization. Chronic tics are the primary symptom. Comprehensive Behavioral Intervention for Tics (CBIT) is a manualized treatment focused on tic management skills. During the core CBIT procedure, competing response training, patients learn to inhibit tics by engaging in a competing motor action. The overall objective of this study is to identify bio-behavioral predictors and correlates of response and the most potent aspects of CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Neural, behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded. CBIT process will be measured with a video-based behavioral coding scheme that will be refined and validated during years 1-2 using archival CBIT videos

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Key information

Conditions

Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Persistent Tic Disorder Tic Disorders

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 10-17 years at time of enrollment.
  • Current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance.
  • At least moderate tic severity, defined as a Yale Global Tic Severity Scale total score ≥14 (≥9 for those with motor or vocal tics only).
  • Full scale IQ greater than 70.
  • Child participant required to have English fluency to ensure comprehension of study measures and instructions.
  • To increase external validity of findings, we will include participants taking psychotropic medications that have been stable for 4 weeks and expect to remain stable for the study period. Individuals receiving non-tic related psychotherapy involving procedures that overlap with CBIT can be eligible to participate if they refrain from receiving treatment once enrolled through the post-treatment assessment. All concurrent treatments will be monitored.

Exclusion criteria

  • Inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia) and/or EEG.
  • Active suicidality Previous diagnosis of psychosis, cognitive disability, or structural brain disease that in the investigator opinion would impede participation.
  • History of seizure disorder
  • Active substance abuse or dependence.
  • Presence of another psychiatric or medical condition requiring immediate treatment and/or for which delay of treatment to focus on tics would be clinically inappropriate. Participants will not be excluded for comorbidities that commonly occur with TS (e.g., ADHD, OCD, anxiety) provided that this criterion is met, as only 10-15% of patients with TS have no comorbidities.
  • Concurrent psychotherapy focused on tics and/or involving procedures that overlap with CBIT (e.g., habit reversal therapy, exposure therapy targeting repetitive behaviors).
  • Psychotropic medication changes in the past 4 weeks and/or plans to change medication during the study period through post-treatment assessment.
  • ≥ 4 previous sessions of CBIT.

Treatment and study plan

CBIT

Other

Participants will receive 8 sessions delivered weekly over 10 weeks. All sessions will be video recorded. CBIT components are: 1) Psychoeducation about tics, 2) Functional interventions, 3) Competing response (CR) training, 4) Social support: supportive people (e.g., parent, teacher) , 5) Motivational enhancements, 6) Homework: is assigned each session and typically involves self-monitoring and CR practice. Participants will complete a brief daily homework tracking log in REDCap.

Primary outcomes

  1. Change in the Total Tic Score on the Yale Global Tic Severity Scale (YGTSS).

    Time frame: 27 weeks

    The YGTSS is a clinician-rated measure that will be scored by a study Independent Evaluator. For each participant, the severity of tics over the past 1 week will be measured using the sing a data-dYGTSS Total Tic Score, which ranges from ranges from 0-50. Outcome will be reported as change from baseline to post-treatment, change from baseline to 1-month post-treatment, and change from post-treatment to 1-month post-treatment.

Secondary outcomes

  1. Change resting-state fMRI connectivity of the brain

    Time frame: 27 weeks

    For each participant, signal intensity (unitless measure) will be measured using fMRI during a state of rest. Signal intensity will be measured within established resting-state brain networks. Analysis will compare within- subject change in signal intensity in these networks from pre- to post treatment; these variables will be entered into multivariate prediction models to identify the relationships between signal intensities and YGTSS Total Tic Scores.

  2. neural, behavioral, and psychosocial changes associated with change in tic severity post-CBIT

    Time frame: 27 weeks

    A data- driven approach will be used to model longitudinal change across multiple key indices to inform reasons for tic severity reduction while identifying therapeutic targets that could be engaged in future research.

  3. Quality of Life: PROMIS Pediatric Profile-49

    Time frame: 27 weeks

    Description: For each participant, quality of life will be measured using the PROMIS Pediatric Profile-49 questionnaire. Each item is scored from 1-5, and scores are added together to measure overall quality of life and functioning across specific domains. Scores will be PROMIS scores will be entered into linear mixed models to see which are related to baseline YGTSS and change in baseline to post-treatment YGTSS.

  4. Components of CBIT sessions

    Time frame: 27 weeks

    Recordings of CBIT session videos will be reviewed to measure the specific components of CBIT that therapists use in units of time (i.e., minutes) and frequency (e.g., number of times the therapist delivers each component across sessions). Generalized linear mixed models will be used to model the association between CBIT components and change on the YGTSS.

  5. Identify CBIT process elements that contribute to response

    Time frame: 27 weeks

    code CBIT session videos to capture observable therapist and patient behaviors.

Study contacts

Contact information is provided by the study sponsor or research team.

Sonya Wang, MD

CONTACT

[email protected]

612-301-1454

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jan 8, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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