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NCT06311474 · ClinicalTrials.gov registry record · NA
Remote Assessment and Intervention for Behavior Problems in Kids With TSC
A NA study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 101
- Enrollment target
NCT06311474: Completed NA study, sponsored by University of California, Los Angeles.
NCT06311474 is a NA study that has completed, run by University of California, Los Angeles. The registered enrollment target is 101 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06311474, a NA study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 101 participants
- Enrollment target
Study Summary
The RAINBOW study is a fully remote study focused on understanding and treating behavior problems in young children with tuberous sclerosis complex (TSC). The first goal is to enroll a group of 100 children with TSC between the ages of 3 and 6 years old, with and without problem behaviors, to learn about how best to measure behavioral challenges in TSC and how common these behaviors are during this age period. All families will get feedback from the clinical assessments collected. Eligible children who are experiencing behavior problems will be invited to enroll in a pilot clinical trial of internet-based Parent-Child Interaction Therapy (or PCIT), which is meant to help parents better manage their children's challenging behaviors. Adaptations to PCIT are incorporated to suit the needs of TSC children and families. Some participants will be randomly selected to receive the intervention immediately and others after a 6-month delay, but all families will receive the same intervention. Intervention sessions occur on a weekly basis for up to 20 weeks. Follow-up assessments, which include play interactions, parent interviews, and questionnaires occur about 3 and 6 months after the first visit. The delayed treatment group has an extra brief assessment about 12 months from the initial visit. This study will increase what is known about the types of behavior problems that come up during preschool age in TSC and how best to help children and families with TSC who are experiencing these problems.
Primary Outcome
The ECBI is a norm-referenced caregiver report measure of disruptive behavior in children.
Interventions
- BEHAVIORAL Parent-Child Interaction Therapy (PCIT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2025-12-04 |
| Phase | NA |
What the finished NCT06311474 record still lists
NCT06311474 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Parent-Child Interaction Therapy (PCIT) is the first listed.
NCT06311474 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06311474 about?
NCT06311474 is a clinical study titled "Remote Assessment and Intervention for Behavior Problems in Kids With TSC". The RAINBOW study is a fully remote study focused on understanding and treating behavior problems in young children with tuberous sclerosis complex (TSC). The first goal is to enroll a group of 100 children with TSC between the ages of 3 and 6 years old, with and without problem behaviors, to learn ...
What is the current status of trial NCT06311474?
This trial is currently completed. It is a NA study. The enrollment target is 101 participants. The study started on 2022-08-01. Estimated completion is 2025-12-04.
What interventions are being tested in trial NCT06311474?
The interventions under investigation include: Parent-Child Interaction Therapy (PCIT) (BEHAVIORAL).
Who is sponsoring clinical trial NCT06311474?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06311474's enrollment target sits among peer trials
101 840th of 2000 higher than 1,161 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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