[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524208":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":35,"responsibleParty":66,"collaborators":69,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":24,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":24,"overallStatus":52,"whyStopped":24,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Parents","EXPERIMENTAL","In this 22-week almost completely remote study, following a 5-week control phase, parents will receive intensive treatment twice per week for 5 weeks followed by a one-time, 1-on-1 counseling session with an RT psychologist (week 11). Then, parents will use skill practice and application in the home environment for 10 weeks. Following this, a final interview is conducted (week 22).",[13],"Behavioral: Behavioral Intervention in a small group platform",{"label":15,"type":10,"description":16,"interventionNames":17},"Children","In this 22-week almost completely remote study, following a 5-week control phase, children will receive intensive group treatment, twice a week for 5 weeks delivered remotely. During the children's sessions, they will use child structured videos, the PlayPosit curriculum and learning rewards. The following assessments will be completed by the parents, regarding their children, at each phase; EDI, ABC-2, FS, BRIEF-2, CRS, PSI-4SF and CGI-I. Following the completion of group treatment, there will be a one-time, 1-on-1 counseling session with an RT psychologist.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","Behavioral Intervention in a small group platform","RT is small-group-based, intensive behavioral intervention session delivered twice weekly over a secure remote platform for 60-minutes over 5 weeks. Each session is led by a psychologist trained and certified in RT. Caregiver groups meet at the same frequency and duration but at different times. Each session has a specific focus for teaching participants to identify emotions and incorporation of cognitive behavioral therapy (CBT) and mindfulness skills that are reinforced through repeated practice. Each session will include a review, relaxation, new material didactic, activities to reinforce material, mindfulness, and homework.",[15,9],null,[26],{"name":27,"affiliation":28,"role":29},"Jamie Capal, MD","University of North Carollina at Chapel Hill","PRINCIPAL_INVESTIGATOR",[31],{"name":27,"role":32,"phone":33,"phoneExt":24,"email":34},"CONTACT","(919) 966-9343","jamie.capal@cidd.unc.edu",[36,50],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":24},"University of North Carolina Chapel Hill-Carolina Institute for Developmental Disabilities","COMPLETED","Carrboro","North Carolina","27510","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-79.07529,35.91014,{"lat":48,"lon":47},{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":42,"countryCode":43,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Cincinnati Children's Hospital Medical Center (CCHMC)","RECRUITING","Cincinnati","Ohio","45229",{"type":45,"coordinates":57},[58,59],-84.51439,39.12711,{"lat":59,"lon":58},[62],{"name":63,"role":32,"phone":64,"phoneExt":24,"email":65},"Darcy Krueger, MD","5136364222","Darcy.krueger@cchmc.org",{"type":29,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Jamie Capal","Pediatric Neurologist-Professor",[70,73],{"name":71,"class":72},"United States Department of Defense","FED",{"name":74,"class":6},"University of Rochester","100524208","regulating-together-in-tuberous-sclerosis-complex-100524208",false,"NCT06105736","Regulating Together in Tuberous Sclerosis Complex","Regulating Together in Tuberous Sclerosis Complex: A Pilot Feasibility Study in Children and Adolescents With TSC-Associated Neuropsychiatric Disorder (TAND)","RT","Inclusion Criteria:\n\n* Children ages 8-17 years inclusive with a documented clinical and\u002For genetic diagnosis of TSC and exhibiting symptoms of behavioral dysregulation (identified on the TAND Checklist having temper tantrums, aggressive outbursts, self-injury, and\u002For impulsivity) are eligible for inclusion.\n\nAdditional inclusion\u002Feligibility criteria include:\n\n* Participants and their caregivers have access to a computer, phone, or tablet with video capability and stable internet connection. If lack of a device or internet service is the sole barrier to eligibility\u002Fparticipation, interested individuals will be connected to a TSC Clinic social worker to link them to existing government and charity programs specifically addressing this disparity in underserved communities and households in need (e.g., the Affordable Connectivity Program).\n* Participants must also be willing to participate in treatment sessions and have minimal levels of functional verbal communication (child and their caregiver must be fluent in English\n* Child must have a minimum IQ\\>65 on the WASI-II at the screening\u002Fbaseline visit).\n\nExclusion Criteria:\n\n* Participants be on a stable medication regimen at least 4 weeks prior to enrollment\n* Do not have a plan to start a new psychosocial intervention (e.g., individual psychotherapy, family psychotherapy, group psychotherapy or social skills training) or behavior medication within 30 days prior to enrollment or at any point during the study. ----Participants with significant disruptive, aggressive, self-injurious or sexually inappropriate behaviors deemed potentially dangerous or overly disruptive to the group dynamic\u002Fsession, having significant co-occurring neuropsychiatric illness warranting other treatment approaches as determined by study clinician (e.g., substance use disorders, psychotic disorders, schizophrenia), or having significant sensory impairment that would limit participation in intervention curriculum\u002Fmaterials (e.g., blindness or uncorrected hearing loss) also will be excluded.","ALL","8 Years","17 Years",{"count":87,"type":88},105,"ESTIMATED","INTERVENTIONAL",[91],"NA","The purpose of this study is to use a program called Regulating Together (RT), a remote, non-pharmacologic intervention to treat symptoms of emotion dysregulation in children and adolescents with Tuberous Sclerosis Complex (TSC) and TSC-Associated Neuropsychiatric Disorder (TAND).",[94,95],"TSC","Behavioral Symptoms","2025-12-18",{"date":98,"type":99},"2025-12-24","ACTUAL",{"date":101,"type":99},"2023-12-20",{"date":103,"type":88},"2026-12-20",{"name":5,"class":6},2]