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NCT06105736 · ClinicalTrials.gov registry record · NA
Regulating Together in Tuberous Sclerosis Complex
A NA study of Behavioral Symptoms and TSC, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- NA
- Development phase
- 105
- Enrollment target
- 2
- Study locations
NCT06105736: Recruiting NA study of Behavioral Symptoms and TSC, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT06105736 is a NA study of Behavioral Symptoms and TSC that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 105 participants, below the 316-participant average among 6 other Behavioral Symptoms trials with a reported enrollment target (67% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06105736, a NA study of Behavioral Symptoms and TSC, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- NA
- Development phase
- 105 participants
- Enrollment target
- 2
- Study locations
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).
Primary Outcome
Prevalence of emotion dysregulation is highly prevalent in TSC patients who exhibit problematic behaviors. The EDI-R score at the screening study visit will determine the EDI-R and determine the presence or absence of emotion dysregulation in the cohort.
Conditions Studied
Interventions
- BEHAVIORAL Behavioral Intervention in a small group platform
Study Locations (2)
North Carolina
- University of North Carolina Chapel Hill-Carolina Institute for Developmental Disabilities - Carrboro
Ohio
- Cincinnati Children's Hospital Medical Center (CCHMC) - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2023-12-20 |
| Est. Completion | 2026-12-20 |
| Phase | NA |
What NCT06105736 shows while recruiting
NCT06105736 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 316-participant average among 6 other Behavioral Symptoms trials with a reported enrollment target (67% lower).
The record links to 2 conditions, with Behavioral Symptoms appearing as the primary indexed condition, and to 1 intervention - of which Behavioral Intervention in a small group platform is the first listed.
NCT06105736 reports a single indexed study location in North Carolina, Ohio.
Frequently Asked Questions
What is clinical trial NCT06105736 about?
NCT06105736 is a clinical study titled "Regulating Together in Tuberous Sclerosis Complex". 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).
What is the current status of trial NCT06105736?
This trial is currently recruiting. It is a NA study. The enrollment target is 105 participants. The study started on 2023-12-20. Estimated completion is 2026-12-20.
What conditions does trial NCT06105736 study?
This clinical trial studies the following conditions: Behavioral Symptoms, TSC.
What interventions are being tested in trial NCT06105736?
The interventions under investigation include: Behavioral Intervention in a small group platform (BEHAVIORAL).
Who is sponsoring clinical trial NCT06105736?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06105736 being conducted?
This trial has 2 study locations across North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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