Regulating Together in Tuberous Sclerosis Complex
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).
| Condition(s) | TSC, Behavioral Symptoms |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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). |
| Who can participate | Inclusion Criteria: * Children ages 8-17 years inclusive with a documented clinical and/or genetic diagnosis of TSC and exhibiting symptoms of behavioral dysregulation (identified on the TAND Checklist having temper tantrums, aggressive outbursts, self-injury, and/or impulsivity) are eligible for inclusion. Additional inclusion/eligibility criteria include: * 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/participation, 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 |
| Ages | 8 Years to 17 Years |
| Sex | All |
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
| Locations | Carrboro, North Carolina, United States; Cincinnati, Ohio, United States |
| Start date | 2023-12-20 |
| NCT ID | NCT06105736 |
| Official listing | https://clinicaltrials.gov/study/NCT06105736 |