Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics

Last updated: July 11, 2024
Sponsor: University of Minnesota
Overall Status: Active - Recruiting

Phase

2

Condition

Tic Disorders

Autism

Treatment

CBIT

Clinical Study ID

NCT06194305
NEUR-2023-32286
  • Ages 10-17
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 withouta tic-free period of more than 3 consecutive months. Tics must not be due to amedical condition or the direct physiological effects of a substance.

  • At least moderate tic severity, defined as a Yale Global Tic Severity Scale totalscore ≥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 studymeasures and instructions.

  • To increase external validity of findings, we will include participants takingpsychotropic medications that have been stable for 6 weeks and expect to remainstable for the study period. Individuals receiving non-tic related psychotherapyinvolving procedures that overlap with CBIT can be eligible to participate if theyrefrain from receiving treatment once enrolled through the post-treatmentassessment. All concurrent treatments will be monitored.

Exclusion

Exclusion Criteria:

  • Inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia) and/orEEG.

  • Active suicidality Previous diagnosis of psychosis, cognitive disability, orstructural brain disease that in the investigator opinion would impedeparticipation.

  • History of seizure disorder

  • Active substance abuse or dependence.

  • Presence of another psychiatric or medical condition requiring immediate treatmentand/or for which delay of treatment to focus on tics would be clinicallyinappropriate. Participants will not be excluded for comorbidities that commonlyoccur with TS (e.g., ADHD, OCD, anxiety) provided that this criterion is met, asonly 10-15% of patients with TS have no comorbidities.

  • Concurrent psychotherapy focused on tics and/or involving procedures that overlapwith CBIT (e.g., habit reversal therapy, exposure therapy targeting repetitivebehaviors).

  • Psychotropic medication changes in the past 6 weeks and/or plans to changemedication during the study period through post-treatment assessment.

  • ≥ 4 previous sessions of CBIT.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: CBIT
Phase: 2
Study Start date:
April 25, 2024
Estimated Completion Date:
February 19, 2029

Connect with a study center

  • University of California

    San Diego, California 92093
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55414
    United States

    Active - Recruiting

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