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NCT05215145 · ClinicalTrials.gov registry record · NA
Baby Navigator Intervention to Improve Outcomes of Toddlers With Communication Delays
A NA study, sponsored by Florida State University.
- Completed
- Registry status
- NA
- Development phase
- 98
- Enrollment target
NCT05215145 is a NA study that has completed, run by Florida State University. The registered enrollment target is 98 participants.
The verdict
NCT05215145, a NA study, has completed, sponsored by Florida State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 98 participants
- Enrollment target
Study Summary
A confluence of empirical research on poverty, environmental risk factors, and brain development shows that early experiences are uniquely powerful in the first years of life, providing further impetus for early detection and intervention. Measures of early-developing social communication skills offer a viable solution for earlier detection of children with language delays and subsequent educational challenges. The investigators propose testing a new technology-supported platform with three parent-mediated intervention components for babies with early communication delays using mobile technology: 1) the Social Communication Growth Charts, a self-guided app to explore video clips illustrating early milestones and to chart their child's development; 2) Baby Navigator Webinar, webinars open to the public designed as a companion to the Growth Charts; and 3) Mobile Coaching, individual weekly telehealth sessions to coach parents in their everyday activities. The investigators propose using a multiphase optimization strategy (MOST) as a framework for development, optimization, and evaluation of our dynamic web intervention platform. The Investigators will recruit 80 children with communication delays at 12-18 months of age. Families will be invited to the Social Communication Growth Charts bundled with the Baby Navigator Webinar. At 18-21 months, slow responders will be randomized to continue the bundle with or without Mobile Coaching, and responders will continue the bundle. This study will enhance the sustainability, scalability, and lead to transformative changes to efficiently and effectively improve healthcare delivery via the use of innovative technology, an implementation science methodology, and user-friendly tools and web platform.
Interventions
- BEHAVIORAL Baby Navigator Bundle
- BEHAVIORAL Baby Navigator Bundle + Individual-ESI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2021-07-14 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05215145
The ClinicalTrials.gov registry entry for NCT05215145 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida State University, which has 219 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Baby Navigator Bundle is the first listed.
NCT05215145 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05215145 about?
NCT05215145 is a clinical study titled "Baby Navigator Intervention to Improve Outcomes of Toddlers With Communication Delays". A confluence of empirical research on poverty, environmental risk factors, and brain development shows that early experiences are uniquely powerful in the first years of life, providing further impetus for early detection and intervention. Measures of early-developing social communication skills off...
What is the current status of trial NCT05215145?
This trial is currently completed. It is a NA study. The enrollment target is 98 participants. The study started on 2021-07-14. Estimated completion is 2025-12-31.
What interventions are being tested in trial NCT05215145?
The interventions under investigation include: Baby Navigator Bundle (BEHAVIORAL), Baby Navigator Bundle + Individual-ESI (BEHAVIORAL).
Who is sponsoring clinical trial NCT05215145?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
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