Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics

Launched by UNIVERSITY OF MINNESOTA · Dec 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Comprehensive Behavioral Intervention for Tics (CBIT) to help children and teenagers aged 10 to 17 who have Tourette Syndrome or Persistent Tic Disorder. These conditions involve repeated movements or sounds called tics, which can seriously affect a child's daily life, emotional well-being, and relationships with peers. The trial aims to find out what factors might help predict how well a child responds to CBIT and to identify the most effective parts of this therapy. Participants will take part in an 8-session course where they will learn skills to manage their tics, and their progress will be closely monitored over time.

To be eligible for this study, participants must have chronic motor or vocal tics for at least a year and must be experiencing moderate tic severity. They should be fluent in English and have an IQ greater than 70. The study is open to both boys and girls, and those who are stable on certain medications may also participate. Throughout the trial, participants can expect to engage in video-recorded therapy sessions, and their brain activity and behavior will be assessed to better understand their responses to the treatment. It’s important to note that certain conditions or recent therapy might exclude some individuals from joining.

Gender

ALL

Eligibility criteria

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