Regulating Together in Tuberous Sclerosis Complex

Last updated: June 7, 2024
Sponsor: University of Rochester
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurofibromatosis

Treatment

Behavioral Intervention in a small group platform

Clinical Study ID

NCT06105736
23-0274
HT9425-23-1-0344
CDMRP-TS220041
  • Ages 8-17
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Children ages 8-17 years inclusive with a documented clinical and/or geneticdiagnosis of TSC and exhibiting symptoms of behavioral dysregulation (identified onthe TAND Checklist having temper tantrums, aggressive outbursts, self-injury, and/orimpulsivity) are eligible for inclusion.

Additional inclusion/eligibility criteria include:

  • Participants and their caregivers have access to a computer, phone, or tablet withvideo capability and stable internet connection. If lack of a device or internetservice is the sole barrier to eligibility/participation, interested individualswill be connected to a TSC Clinic social worker to link them to existing governmentand charity programs specifically addressing this disparity in underservedcommunities and households in need (e.g., the Affordable Connectivity Program).

  • Participants must also be willing to participate in treatment sessions and haveminimal levels of functional verbal communication (child and their caregiver must befluent in English

  • Child must have a minimum IQ>65 on the WASI-II at the screening/baseline visit).

Exclusion

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., individualpsychotherapy, family psychotherapy, group psychotherapy or social skills training)or behavior medication within 30 days prior to enrollment or at any point during thestudy. ----Participants with significant disruptive, aggressive, self-injurious orsexually inappropriate behaviors deemed potentially dangerous or overly disruptiveto the group dynamic/session, having significant co-occurring neuropsychiatricillness warranting other treatment approaches as determined by study clinician (e.g., substance use disorders, psychotic disorders, schizophrenia), or havingsignificant sensory impairment that would limit participation in interventioncurriculum/materials (e.g., blindness or uncorrected hearing loss) also will beexcluded.

Study Design

Total Participants: 105
Treatment Group(s): 1
Primary Treatment: Behavioral Intervention in a small group platform
Phase:
Study Start date:
December 20, 2023
Estimated Completion Date:
December 20, 2026

Study 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).

Connect with a study center

  • University of North Carolina Chapel Hill-Carolina Institute for Developmental Disabilities

    Carrboro, North Carolina 27510
    United States

    Completed

  • Cincinnati Children's Hospital Medical Center (CCHMC)

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

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