CompletedNot Applicable

Baby Navigator Intervention to Improve Outcomes of Toddlers With Communication Delays

United States98 participantsStarted 2021-07-14

Plain-language 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.

Who can participate

Age range12 Months – 18 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria for parent/child dyads: * parent completes the SoCo CheckUp (available at https://babynavigator.com) screening at 12-18 months of age and child has a positive screen for communication delay * parent completes the CSBS CQ and child falls below the 10th percentile at 12-18 months * parent records and submits/uploads a home observation video at 12-18 months * speaks English or Spanish at home * agrees to be in the intervention study Exclusion Criteria: * 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

What they're measuring

Parent contingent responsiveness change over time

Timeframe: Baseline, and 6-12 months after start of intervention

Child social communication change over time

Timeframe: Baseline, and 6-12 months after start of intervention

Trial details

NCT IDNCT05215145

SponsorFlorida State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31