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Regulating Together for Behavioral Symptoms in Tuberous Sclerosis Complex

This study is testing a program called Regulating Together (RT), a remote, group-based behavioral intervention, to help children and teenagers with Tuberous Sclerosis Complex (TSC) and TSC-Associated Neuropsychiatric Disorder (TAND) manage behavioral symptoms like temper tantrums, aggression, and impulsivity. The study aims to see if RT can improve these symptoms. You might be able to join if you are 8 to 17 years old, have a diagnosis of TSC, and experience behavioral dysregulation. The study is looking for 105 participants. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 105 participants. It involves a behavioral intervention delivered in small groups.
What's involved
You would have an in-person screening visit, followed by a 5-week observation period. Then, you would participate in remote group treatment twice a week for 5 weeks, an individualized consultation, and a 10-week follow-up period using learned skills at home.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 10 weeks after the intensive treatment phase to see how well they use the learned skills at home.

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NCT06105736

Regulating Together in Tuberous Sclerosis Complex

Recruiting
NAAges 8–17InterventionalDiagnostic
Children's Hospital Medical Center, Cincinnati
~105 participants
Updated 2025-12-24 on ClinicalTrials.gov
What's tested:Behavioral Intervention in a small group platform

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prevalence of ED in TSC Cohort
Measured over Baseline
+2 more outcomes measured

Conditions

TSC
Behavioral Symptoms

Explore related trials

Tuberous SclerosisTuberous Sclerosis Complex-Associated Neuropsychiatric Disorder

Where it's being run

2 sites across 2 states
North Carolina1
Ohio1

Study leadership

  • Jamie Capal, MD · PRINCIPAL_INVESTIGATOR · University of North Carollina at Chapel Hill

Who to contact

Jamie Capal, MD
[email protected]
(919) 966-9343
Email the study team

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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.
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.

What this trial measures

  • Prevalence of ED in TSC CohortBaseline

    Prevalence of emotion dysregulation is highly prevalent in TSC patients who exhibit problematic behaviors. The EDI-R score at the screening study visit will determine the EDI-R and determine the presence or absence of emotion dysregulation in the cohort.

  • Change in EDI-R Score from Control Phase to RT Intensive and RT Generalization Phases CombinedIntensive Phase (Week 6-10) and Generalization Phase (Week 12-22)

    EDI-R score will be compared from pre-treatment (control phase) to post-treatment (RT Intensive Phase and RT Generalization Phases combined). EDI-R is a caregiver administered, emotion dysregulation inventory with construct, range, and directionality that includes questions that the rater is asked to answer based on behaviors that are observed to cause problems. These questions include, but are not limited to, creating a dangerous situation, interference with daily activities, increasing the stress of those around the individual, and hurting relationships. There are 13 questions on the EDI-R; they are rated at, not at all, mild, moderate, severe, and very severe.

  • Change in CP-CTI score from pre-treatment to post-treatmentAdministered after completion of RT (Week 22)

    The primary endpoint will be CP-CTI responses from caregivers upon completion of RT Generalization Phase using a thematic analysis. This will identify obstacles to treatment access. Scores will be compared pre-treatment to post-treatment. CP-CTI is a staff administered, caregiver perspective clinical trial interview. This will occur through a telephone call from the study team to the caregiver.