Document text
Principal Investigator: Christine A Conelea
Organization: UNIVERSITY OF MINNESOTA
Fiscal Year: 2024
Award: $771,128
Funding agency: National Institute of Mental Health
PROJECT SUMMARY
The overall objective of this proposal is to conduct the first mechanistic clinical trial of pediatric Comprehensive
Behavioral Intervention for Tics (CBIT) to identify bio-behavioral predictors and correlates of response and the
most potent aspects of CBIT delivery. Chronic tics affect 1-3% of youth in the US and are a disabling
neuropsychiatric symptom associated with multiple childhood-onset mental disorders. CBIT is the current
first-line, gold-standard treatment for tics and focuses on skills to enhance voluntary tic suppression and
reduce tic triggers. However, about 50% of youth do not benefit from CBIT. The current study aims to use
multimodal measurements to identify predictors of response (for whom does CBIT work?), the therapeutic
processes that activate change (what are the potent aspects of CBIT delivery?), and correlates of response
(what changes occur in patients whose tics improve?). Study hypotheses, based on the literature and our
preliminary data, predict that CBIT relies upon, engages, and strengthens connectivity within and between
functional brain networks that support top-down control over motor functions. Youth ages 10-17 years with
chronic tics (N = 100) will complete a course of 8 outpatient, weekly sessions of CBIT and pre-, post-, and
3-month follow up assessments. Multimodal assessments will include: 1) neural measures of functional
connectivity among the brain's large-scale functional networks using fMRI and EEG during rest and tic
expression and suppression, 2) direct-observation behavioral measurement of tics, and 3) psychosocial
measures, including assessments of clinical symptoms and patient-centered outcome measures informed by
preliminary data and our Patient Advisory Board. CBIT process will be assessed via a novel video-based
behavioral coding of CBIT sessions. This project has the potential to directly benefit patients both immediately
and in the long-term. Results will have a downstream impact on clinical practice by informing individualized
treatment planning and efforts to streamline and improve CBIT quality. Results will also have an upstream
impact on treatment development by identifying novel neural targets for intervention and strategies for
improving CBIT outcomes via refinement or adjunctive procedures.
Terms: <0-11 years old><Affect><Age><Behavior><Behavior Conditioning Therapy><Behavior Modification><Behavior Therapy><Behavior Treatment><Behavioral><Behavioral Conditioning Therapy><Behavioral Modification><Behavioral Therapy><Behavioral Treatment><Brain><Brain Nervous System><Cell Communication and Signaling><Cell Signaling><Child><Child Youth><Childhood><Children (0-21)><Chronic><Clinical><Clinical Trials><Clinical assessments><Code><Coding System><Conditioning Therapy><Data><Decision Making><Development and Research><Disabling><EEG><Electroencephalogram><Electroencephalography><Elements><Encephalon><Functional MRI><Functional Magnetic Resonance Imaging><Future><Gilles de la Tourette syndrome><Gilles de la Tourette's Disease><Goals><Guinon's disease><Impairment><Improve Access><Impulsivity><Intervention><Intervention Strategies><Intracellular Communication and Signaling><Knowledge><Link><Literature><Logistic Regressions><MRI/EEG><MRI/electroencephalography><Measurement><Measures><Mental disorders><Mental health disorders><Methods><Modeling><Motor><Movement><Multi-Institutional Clinical Trial><Multi-center clinical trial><Multi-site clinical trial><Multicenter clinical trial><Multisite clinical trial><Obsessive-Compulsive Disorder><Obsessive-Compulsive Neurosis><Out-patients><Outcome><Outcome Measure><Outpatients><Patient outcome><Patient-Centered Outcomes><Patient-Focused Outcomes><Patients><Procedures><Process><Provider><Psychiatric Disease><Psychiatric Disorder><R & D><R&D><Research><Rest><Sampling><Seminal><Severities><Signal Transduction><Signal Transduction Systems><Signaling><Symptoms><Therapeutic><Tic Disorder, Combined Vocal and Multiple Motor><Tic disorder><Tourette Syndrome><Tourette's><Tourette's Disease><Tourette's Disorder><Tourette's Syndrome><Work><Youth><Youth 10-21><ages><associated symptom><behavior intervention><behavior measurement><behavior observation><behavioral intervention><behavioral measure><behavioral measurement><behavioral observation><bench-to-bedside translation><biobehavior><biobehavioral><biological signal transduction><body movement><clinical practice><co-morbid symptom><co-occuring symptom><comorbid symptom><computer based prediction><concurrent symptom><cooccuring symptom><customized therapy><customized treatment><design><designing><develop therapy><efficacy trial><experience><fMRI><fMRI/EEG><follow up assessment><followup assessment><functional magnetic resonance imaging/electroencephalography><improved><indexing><individualized medicine><individualized patient treatment><individualized therapeutic strategy><individualized therapy><individualized treatment><intervention development><interventional strategy><kids><magnetic resonance imaging/electroencephalography><maladie des tics><measurable outcome><member><mental illness><motor control><multi-modality><multidisciplinary><multimodality><neural><neural control><neural regulation><neuromodulation><neuromodulatory><neuropsychiatric disease><neuropsychiatric disorder><neuropsychiatric symptom><neuroregulation><novel><outcome measurement><participant engagement><patient engagement><patient oriented outcomes><patient profile><patient specific therapies><patient specific treatment><pediatric><predict responsiveness><predicting response><predictive biomarkers><predictive marker><predictive modeling><predictive molecular biomarker><primary care setting><profiles in patients><prognostic indicator><psychiatric illness><psychological disorder><psychosocial><repetitive behavior><research and development><response><skills><standard care><standard treatment><support network><symptom association><symptom comorbidity><tailored medical treatment><tailored therapy><tailored treatment><therapeutic target><therapy development><tic de Guinon><tic suppression><treatment adherence><treatment compliance><treatment development><treatment planning><unique treatment><vocalization><youngster>