Baby Navigator Intervention to Improve Outcomes of Toddlers With Communication Delays

Completed · Not applicable

Conditions studied: Social Communication

In brief

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.

Key facts

Study ID

NCT05215145

Run by

Florida State University

People needed

98

Starts

2021-07-14

Expected to finish

2025-12-31

Last updated by the study team

2026-02-17

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• child over 18 months of age at beginning of study
• child shows 5 or more red flags for autism based on the home observation video scored with the SORF (Systematic Observation of Red Flags) of ASD
• parent/child dyad does not speak English or Spanish
• family lives outside of the United States
• parent does not agree to be video recorded as part of the study

Where it is running

• Florida State University Autism Institute — Tallahassee, Florida, United States

Full record on ClinicalTrials.gov

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