RECRUITING

Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics

Conditions

Tourette Syndrome Persistent Tic Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics

Quick Facts

Study Start:2024-04-25

Study Completion:2029-02-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06194305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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 6 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.	* 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 6 weeks and/or plans to change medication during the study period through post-treatment assessment. * ≥ 4 previous sessions of CBIT.

Inclusion Criteria

Exclusion 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 6 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.

* 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 6 weeks and/or plans to change medication during the study period through post-treatment assessment.
* ≥ 4 previous sessions of CBIT.

Contacts and Locations

Study Contact

Sonya Wang, MD

CONTACT

612-301-1454

ticlab@umn.edu

Principal Investigator

Christine Conelea, PhD, LP

PRINCIPAL_INVESTIGATOR

University of Minnesota

Deanna Greene, PhD

PRINCIPAL_INVESTIGATOR

University of California, San Diego

Sonya Wang, MD

PRINCIPAL_INVESTIGATOR

University of Minnesota

Study Locations (Sites)

University of California

San Diego, California, 92093

United States

University of Minnesota

Minneapolis, Minnesota, 55414

United States

Collaborators and Investigators

Sponsor: University of Minnesota

Christine Conelea, PhD, LP, PRINCIPAL_INVESTIGATOR, University of Minnesota
Deanna Greene, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Diego
Sonya Wang, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-25

Study Completion Date2029-02-19

Study Record Updates

Study Start Date2024-04-25

Study Completion Date2029-02-19

Terms related to this study

Additional Relevant MeSH Terms

Tourette Syndrome
Persistent Tic Disorder