Regulating Together in Tuberous Sclerosis Complex

Part of paid clinical trials in Carrboro, North Carolina.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT06105736
Status
Recruiting
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Conditions

  • Behavioral Symptoms
  • TSC

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Behavioral Intervention in a small group platform — BEHAVIORAL
    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.

Study Details

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).

Key Dates

Start date
Dec 20, 2023
Status verified
Dec 2025
Primary completion
Dec 20, 2026
Completion
Dec 20, 2026

Study Design

Enrollment
105 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Prevalence of ED in TSC Cohort [ Time Frame: Baseline ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of North Carolina Chapel Hill-Carolina Institute for Developmental DisabilitiesCarrboroNorth Carolina27510-
Cincinnati Children's Hospital Medical Center (CCHMC)CincinnatiOhio45229
Darcy Krueger, MD
[email protected]
5136364222

Find similar trials in Carrboro, NC

By research site
University of North Carolina Chapel Hill-Carolina Institute for Developmental Disabilities· Carrboro, NCCincinnati Children's Hospital Medical Center (CCHMC)· Cincinnati, OH

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