Remote intervention for emotional regulation in children with Tuberous Sclerosis Complex

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cincinnati Children's Hospital Medical Center (CCHMC)
  Cincinnati, Ohio, United States Recruiting
• University of North Carolina Chapel Hill-Carolina Institute for Developmental Disabilities
  Carrboro, North Carolina, United States Completed

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Urine, perineal, and stool microbiota in children and adolescents

  We will test whether the bacteria in voided urine, around the genitals, and in stool differ between children with overactive bladder or daytime wetting and healthy children of the same age and gender.

  Recruiting at 2 sites Aalborg University Hospital · Aalborg and 3 other locations · NCT07535619

• Combining the Youth-Nominated Support Team with CBT for Black adolescents at acute suicide risk

  This project will test whether adding a computer-assisted Youth-Nominated Support Team to Cognitive Behavioral Therapy for Suicide Prevention helps Black adolescents (ages 12-17) who come to an urban emergency setting with suicidal thoughts or self-injury.

  Recruiting at 2 sites University of Michigan · Detroit, Michigan and 1 other locations · NCT07506460

• Improving wellbeing in young children of mothers with mental health issues

  This study tests if an online program can help mothers with serious mental health issues improve their parenting skills and support the emotional development of their young children aged 1 to 3.

  Recruiting University of Southern Denmark · Odense C, Region Syddanmark · NCT06795347

• Testing a new drug for treatment-resistant depression

  This study is testing a new drug called HNK to see if it can help people with treatment-resistant depression feel better when other medications haven't worked.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06511908

• Understanding the impact of mood disorders and treatment responses

  This study is trying to learn more about how people with depression and bipolar disorder respond to treatment by talking to them weekly for up to 12 weeks to improve future care and predict how well medications might work.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06462196

• Health Equity and Rural Education (HERE!) school program

  This project will test whether a school-based community health worker program can help rural middle and high school students (grades 6–12) with poor attendance and their families get support for social needs and behavioral health.

  Recruiting University of Kansas Medical Center · Kansas City, Kansas · NCT06460116

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.