Remote intervention for emotional regulation in children with Tuberous Sclerosis Complex
Regulating Together in Tuberous Sclerosis Complex: A Pilot Feasibility Study in Children and Adolescents With TSC-Associated Neuropsychiatric Disorder (TAND)
This study is testing a remote program to help children with Tuberous Sclerosis Complex learn to manage their emotions better through group therapy and support for their caregivers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 8 Years to 17 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 2 sites (Carrboro, North Carolina and 1 other locations) |
| Trial ID | NCT06105736 on ClinicalTrials.gov |
What this trial studies
This study aims to implement a program called Regulating Together (RT), which is a remote, non-pharmacological intervention designed to address emotional dysregulation in children and adolescents diagnosed with Tuberous Sclerosis Complex (TSC) and TSC-Associated Neuropsychiatric Disorder (TAND). The intervention consists of small group therapy sessions followed by caregiver consultations, spanning over several phases including screening, an observational control phase, intensive remote treatment, individual consultations, and a follow-up period to practice learned skills at home. The study will also include thematic analysis through semi-structured interviews to identify facilitators and barriers to the intervention's effectiveness. Overall, the approach focuses on enhancing emotional regulation skills in a supportive environment.
Who should consider this trial
Good fit: Ideal candidates are children aged 8-17 years with a clinical or genetic diagnosis of TSC who exhibit symptoms of behavioral dysregulation.
Not a fit: Patients who do not exhibit behavioral dysregulation or are outside the age range of 8-17 years may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve emotional regulation and behavioral symptoms in children with TSC, enhancing their quality of life.
How similar studies have performed: Other studies have shown promise with similar non-pharmacological interventions for behavioral issues, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Carrboro, North Carolina and 1 other locations
- University of North Carolina Chapel Hill-Carolina Institute for Developmental Disabilities — Carrboro, North Carolina, United States (Completed)
- Cincinnati Children's Hospital Medical Center (CCHMC) — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jamie Capal, MD — University of North Carollina at Chapel Hill
- Study coordinator: Jamie Capal, MD
- Email: jamie.capal@cidd.unc.edu
- Phone: (919) 966-9343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.