Baby Navigator Intervention to Improve Outcomes of Toddlers With Communication Delays
Public ClinicalTrials.gov record NCT05215145. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Effects of Technology-Supported Social Communication Baby Navigator Intervention to Improve Outcomes of Toddlers With Communication Delays: Preliminary Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05215145
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 98 participants
Conditions and interventions
Conditions
Interventions
- Baby Navigator Bundle Behavioral
- Baby Navigator Bundle + Individual-ESI Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 12 Months to 18 Months
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 13, 2021
- Primary completion
- Dec 30, 2025
- Completion
- Dec 30, 2025
- Last update posted
- Feb 16, 2026
2021 – 2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Florida State University Autism Institute | Tallahassee | Florida | 32309 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05215145, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 16, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05215145 live on ClinicalTrials.gov.