Regulating Together in Tuberous Sclerosis Complex (NCT06105736) | Clinical Trial Compass
RecruitingNot Applicable
Regulating Together in Tuberous Sclerosis Complex
United States105 participantsStarted 2023-12-20
Plain-language 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
Age range8 Years – 17 Years
SexALL
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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 (e.g., the Affordable Connectivity Program).
* 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
* Child must have a minimum IQ\>65 on the WASI-II at the screening/baseline visit).
Exclusion Criteria:
* Participants be on a stable medication regimen at least 4 weeks prior to enrollment
* 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 w…
What they're measuring
1
Prevalence of ED in TSC Cohort
Timeframe: Baseline
2
Change in EDI-R Score from Control Phase to RT Intensive and RT Generalization Phases Combined
Timeframe: Intensive Phase (Week 6-10) and Generalization Phase (Week 12-22)
3
Change in CP-CTI score from pre-treatment to post-treatment
Timeframe: Administered after completion of RT (Week 22)
Trial details
NCT IDNCT06105736
SponsorChildren's Hospital Medical Center, Cincinnati