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Brief Title: Regulating Together in Tuberous Sclerosis Complex
Official Title: Regulating Together in Tuberous Sclerosis Complex: A Pilot Feasibility Study in Children and Adolescents With TSC-Associated Neuropsychiatric Disorder (TAND)
Study ID: NCT06105736
Brief Summary: 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).
Detailed Description: This is a non-pharmacological intervention that will utilize small group-based therapy with participants, followed by a separate caregiver session. The clinical trial will consist of four phases; 1) single in person screening/baseline visit; 2) RT control phase which is a 5-week observational period (Week 1-5); 3) RT intensive phase which is a remote group treatment intervention twice per week over 5 weeks (Week 6-10); 4) RT individualization phase, which is an individualized consultation with the participant and caregiver (Week 11); and 5) the RT generalization phase which is a 10 week follow up period consisting of utilizing the learned skills at home. At the end of the 10-week generalization phase, a semi-structured interview for thematic analysis will occur at the end of the study to capture facilitators and barriers to the intervention (Week 12-22).
Minimum Age: 8 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
University of North Carolina Chapel Hill-Carolina Institute for Developmental Disabilities, Carrboro, North Carolina, United States
Cincinnati Children's Hospital Medical Center (CCHMC), Cincinnati, Ohio, United States
Name: Jamie Capal, MD
Affiliation: University of North Carollina at Chapel Hill
Role: PRINCIPAL_INVESTIGATOR