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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: Completed NA study, sponsored by Florida State University.
NCT05215145 is a NA study that has completed, run by Florida State University. The registered enrollment target is 98 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
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.
Primary Outcome
Parent contingent responsiveness will be periodically assessed using the Measure of Active Engagement and Transactional Supports (MAETS), a rating of a video-recorded home observation of parent-child interaction during everyday activities. The MAETS includes 8 AE components: participation and a productive role; predictable activities; language that follows the child's focus of attention; child initiations; balance of communicative turns; messages to support child comprehension; verbal and nonver
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 |
What the finished NCT05215145 record still lists
NCT05215145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, 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 2 interventions - of which Baby Navigator Bundle is the first listed.
NCT05215145 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05215145's enrollment target sits among peer trials
98 922nd of 2000 higher than 1,078 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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