Phase
Condition
Neurofibromatosis
Treatment
Behavioral Intervention in a small group platform
Clinical Study ID
Ages 8-17 All Genders
Study Summary
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
Study Description
Connect with a study center
University of North Carolina Chapel Hill-Carolina Institute for Developmental Disabilities
Carrboro, North Carolina 27510
United StatesCompleted
Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, Ohio 45229
United StatesActive - Recruiting
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