Who may be eligible for the Regulating Together in Tuberous Sclerosis Complex trial?

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 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.

ClinicalTrials.gov record NCT06105736

Regulating Together in Tuberous Sclerosis Complex

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Regulating Together in Tuberous Sclerosis Complex: A Pilot Feasibility Study in Children and Adolescents With TSC-Associated Neuropsychiatric Disorder (TAND)

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

Age8 years old to 17 years old

SexAll

LocationUnited States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a non-drug, small-group program called Regulating Together (RT) for children and adolescents with TSC and TSC-associated neuropsychiatric disorder (TAND). The study includes a baseline visit, a 5-week observation (control) period, a 5-week remote intensive group treatment (twice weekly) with separate caregiver sessions, a one-on-one consultation, and a 10-week home practice/follow-up, ending with an interview. Caregivers provide most outcome ratings.

What it is studying. The study tests the Regulating Together (RT) remote group program and measures caregiver-rated emotion dysregulation before and after the program, plus caregiver-reported barriers and facilitators to using the intervention.

What the researchers hope to learn. Measure how common emotion dysregulation is in the enrolled TSC cohort using the EDI-R at baseline; compare EDI-R scores from the control period to the combined intensive and generalization phases; and use caregiver interviews (CP-CTI) with thematic analysis to identify obstacles and facilitators to accessing and using the intervention.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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).

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Behavioral: Behavioral Intervention in a small group platform

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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) single in person screening/baseline visit; 2) RT control phase which is a 5-week observational period (Week 1-5); 3) RT intensive phase which is a remote group treatment intervention twice per week over 5 weeks (Week 6-10); 4) RT individualization phase, which is an individualized consultation with the participant and caregiver (Week 11); and 5) the RT generalization phase which is a 10 week follow up period consisting of utilizing the learned skills at home. At the end of the 10-week generalization phase, a semi-structured interview for thematic analysis will occur at the end of the study to capture facilitators and barriers to the intervention (Week 12-22).

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After a single in-person screening/baseline visit (including the WASI-II IQ test), families complete a 5-week observational control phase, then a 5-week remote small-group treatment (60-minute sessions twice weekly) for children with parallel caregiver groups. Following group treatment there is a one-time individual consultation with an RT psychologist, then a 10-week home practice/generalization period. Caregivers will complete standardized behavior rating forms (for example EDI, ABC-2, BRIEF-2 and others) during study phases and take part in a final semi-structured phone interview at study end. Sessions are delivered remotely, so regular access to a video-capable device and stable internet is required.

How the study is structured. Interventional (diagnostic purpose), non-randomized, open-label, parallel groups. Participants complete a screening/baseline visit, a 5-week control observation, a 5-week intensive remote group treatment (60-minute sessions twice weekly) with separate caregiver groups, a one-time individualized consultation, and a 10-week follow-up period, finishing with a semi-structured interview.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under TSC; Behavioral Symptoms. Does it apply to my diagnosis?
The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on tuberous sclerosis complex

Clinical trials30 trials listed for tuberous sclerosis complexEvery trial the registry lists for tuberous sclerosis complex, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in tuberous sclerosis complex researchLatest monthly update: September 2026. Includes: CBD add-on therapy. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Dec 20, 2023
Primary completion: Dec 20, 2026 (estimated)
Study completion: Dec 20, 2026 (estimated)
Target enrollment: 105 participants (estimated)
Last updated on registry: Dec 24, 2025
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Children's Hospital Medical Center, Cincinnati
Principal investigator: Jamie Capal, Pediatric Neurologist-Professor
Children's Hospital Medical Center, Cincinnati
Collaborators: United States Department of Defense
University of Rochester

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Jamie Capal, MD 📞 (919) 966-9343 ✉ jamie.capal@cidd.unc.edu

Participating sites (2)

University of North Carolina Chapel Hill-Carolina Institute for Developmental DisabilitiesCompleted
Carrboro, North Carolina, 27510 · United States
Cincinnati Children's Hospital Medical Center (CCHMC)Recruiting
Cincinnati, Ohio, 45229 · United States
- Darcy Krueger, MD · 5136364222 · Darcy.krueger@cchmc.org

Terms used on this page · explanations by MedicalUpdates.ai

eligibility criteria: The rules the study team uses to decide who may take part. They are usually split into inclusion criteria and exclusion criteria.
baseline: Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
observational: A study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
follow up: The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials