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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 17
Healthy Volunteers: f
View:

• 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).

Locations
United States
North Carolina
University of North Carolina Chapel Hill-Carolina Institute for Developmental Disabilities
COMPLETED
Carrboro
Ohio
Cincinnati Children's Hospital Medical Center (CCHMC)
RECRUITING
Cincinnati
Contact Information
Primary
Jamie Capal, MD
jamie.capal@cidd.unc.edu
(919) 966-9343
Time Frame
Start Date: 2023-12-20
Estimated Completion Date: 2026-12-20
Participants
Target number of participants: 105
Treatments
Experimental: Parents
In this 22-week almost completely remote study, following a 5-week control phase, parents will receive intensive treatment twice per week for 5 weeks followed by a one-time, 1-on-1 counseling session with an RT psychologist (week 11). Then, parents will use skill practice and application in the home environment for 10 weeks. Following this, a final interview is conducted (week 22).
Experimental: Children
In this 22-week almost completely remote study, following a 5-week control phase, children will receive intensive group treatment, twice a week for 5 weeks delivered remotely. During the children's sessions, they will use child structured videos, the PlayPosit curriculum and learning rewards. The following assessments will be completed by the parents, regarding their children, at each phase; EDI, ABC-2, FS, BRIEF-2, CRS, PSI-4SF and CGI-I. Following the completion of group treatment, there will be a one-time, 1-on-1 counseling session with an RT psychologist.
Sponsors
Collaborators: United States Department of Defense
Leads: University of Rochester

This content was sourced from clinicaltrials.gov