protocolSection identificationModule nctId: NCT06270251, orgStudyIdInfo id: PSYCH-2023-32292, briefTitle: Modeling Tic Change During Behavior Therapy for Tics, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2028-03-01, completionDateStruct date: 2028-09-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: Chronic tics are a disabling neuropsychiatric symptom associated with multiple child-onset mental disorders. Chronic tics 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 of Tourette Syndrome (TS) and Persistent Motor/Vocal Tic Disorders.CBIT is a manualized treatment focused on increasing tic controllability. Its core procedure is competing response training (CRT), in which patients learn to inhibit tics by learning and applying a competing motor action to one tic at a time. CBIT is recommended as a first-line treatment relative to medications and other therapies. However, only 52% of children and 38% of adults show clinically meaningful tic improvement. Large randomized trials have demonstrated the superiority of CBIT over supportive therapy in child and adult patients, and meta-analysis shows comparable effect sizes for CBIT and medication. Although increasing tic controllability is the primary goal of CBIT, tic controllability nor its correlates have been examined longitudinally during the intervention.The overall objective of this study is to use fine-grained data collection strategies to identify patterns in tic controllability and other relevant related variables that are associated with treatment response to CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded., conditionsModule conditions: Chronic Tic Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: CBIT, outcomesModule primaryOutcomes measure: Tic Severity, primaryOutcomes measure: Sheehan Disability scale, primaryOutcomes measure: Behavior Rating Inventory of Executive Function, primaryOutcomes measure: Ask Suicide-Screening Questions (ASQ), primaryOutcomes measure: Child Attitudes Toward Illness Scale (CATIS), primaryOutcomes measure: Rosenberg Self-Esteem Scale, primaryOutcomes measure: Caregiver Strain Questionnaire, primaryOutcomes measure: Clinical Global Impressions (CGI), primaryOutcomes measure: Parent/Adult Tic Questionnaire, secondaryOutcomes measure: Premonitory Urge for Tics Scale, secondaryOutcomes measure: Tic Suppression Task, secondaryOutcomes measure: Stop signal task, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of Minnesota, status: RECRUITING, city: Minneapolis, state: Minnesota, zip: 55414, country: United States, contacts name: Brianna Wellen, role: CONTACT, geoPoint lat: 44.97997, lon: -93.26384, hasResults: False