Actively Recruiting
Regulating Together in Tuberous Sclerosis Complex
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-12-24
105
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Regulating Together in Tuberous Sclerosis Complex
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 8 to 17 years with a documented clinical and/or genetic diagnosis of TSC
- Exhibiting symptoms of behavioral dysregulation such as temper tantrums, aggressive outbursts, self-injury, or impulsivity
- Participants and caregivers have access to a computer, phone, or tablet with video capability and stable internet
- Willingness to participate in treatment sessions
- Minimal functional verbal communication with fluency in English for both child and caregiver
- Child must have a minimum IQ greater than 65 on the WASI-II at screening/baseline visit
You will not qualify if you...
- Not on a stable medication regimen for at least 4 weeks before enrollment
- Planning to start a new psychosocial intervention or behavior medication within 30 days before or during the study
- Significant disruptive, aggressive, self-injurious, or sexually inappropriate behaviors that could disrupt group sessions
- Significant co-occurring neuropsychiatric illness requiring other treatments (e.g., substance use disorders, psychotic disorders, schizophrenia)
- Significant sensory impairment limiting participation (e.g., blindness or uncorrected hearing loss)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of North Carolina Chapel Hill-Carolina Institute for Developmental Disabilities
Carrboro, North Carolina, United States, 27510
Completed
2
Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
J
Jamie Capal, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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