Status:
RECRUITING
Regulating Together in Tuberous Sclerosis Complex
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
United States Department of Defense
University of Rochester
Conditions:
TSC
Behavioral Symptoms
Eligibility:
All Genders
8-17 years
Phase:
NA
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 Tube...
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) s...
Eligibility Criteria
Inclusion
- 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
- 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 with significant disruptive, aggressive, self-injurious or sexually inappropriate behaviors deemed potentially dangerous or overly disruptive to the group dynamic/session, 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/materials (e.g., blindness or uncorrected hearing loss) also will be excluded.
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2026
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT06105736
Start Date
December 20 2023
End Date
December 20 2026
Last Update
December 24 2025
Active Locations (2)
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1
University of North Carolina Chapel Hill-Carolina Institute for Developmental Disabilities
Carrboro, North Carolina, United States, 27510
2
Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, Ohio, United States, 45229