Regulating Together in Tuberous Sclerosis Complex

Trial Title: Regulating Together in Tuberous Sclerosis Complex

NCT ID: NCT06105736

Condition: TSC
Behavioral Symptoms

Conditions: Official terms:
Tuberous Sclerosis
Behavioral Symptoms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Behavioral Intervention in a small group platform
Description: RT is small-group-based, intensive behavioral intervention session delivered twice weekly over a secure remote platform for 60-minutes over 5 weeks. Each session is led by a psychologist trained and certified in RT. Caregiver groups meet at the same frequency and duration but at different times. Each session has a specific focus for teaching participants to identify emotions and incorporation of cognitive behavioral therapy (CBT) and mindfulness skills that are reinforced through repeated practice. Each session will include a review, relaxation, new material didactic, activities to reinforce material, mindfulness, and homework.
Arm group label: Children
Arm group label: Parents

Summary: 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).

Detailed description: 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).

Criteria for eligibility:
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.

Gender: All

Minimum age: 8 Years

Maximum age: 17 Years

Healthy volunteers: No

Locations:

Facility:
Name: University of North Carolina Chapel Hill-Carolina Institute for Developmental Disabilities

Address:
City: Carrboro
Zip: 27510
Country: United States

Status: Completed

Facility:
Name: Cincinnati Children's Hospital Medical Center (CCHMC)

Address:
City: Cincinnati
Zip: 45229
Country: United States

Status: Recruiting

Contact:
Last name: Darcy Krueger, MD

Phone: 513-636-4222
Email: Darcy.krueger@cchmc.org

Start date: December 20, 2023

Completion date: December 20, 2026

Lead sponsor:
Agency: University of Rochester
Agency class: Other

Collaborator:
Agency: United States Department of Defense
Agency class: U.S. Fed

Source: University of Rochester

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06105736