Baby Navigator Intervention to Improve Outcomes of Toddlers With Communication Delays

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.

Conditions

• Social Communication

Interventions

BEHAVIORAL

Baby Navigator Bundle

The Baby Navigator Bundle includes 1) Baby Navigator, an online collection of resources: videos, growth charts, milestones, short articles, checklists, tools, and tips to help families promote early learning. Tools are customized to the child's age (in months). Baby Navigator can be found at https://babynavigator.com. 2) Social Communication (SoCo) Growth Charts is a self-guided app for parents of babies from birth to 24 months. Parents can watch video clips of early milestones and chart their child's social communication development. 3) Baby Navigator Webinars are held twice a month. Parents can learn how to support their child's growth from birth to 24 months. Content and videos focus on social communication milestones. Expert-led sessions cover a range of topics: gestures and sounds babies need to learn to talk, everyday activities that encourage learning, getting ahead of the Terrible Twos, and how Baby Navigator can help families.

BEHAVIORAL

Baby Navigator Bundle + Individual-ESI

Continued Baby Navigator Bundle. Addition of ESI mobile coaching. ESI program planning entails identifying goals and objectives for the child and teaching strategies and supports for parents. Each session includes the following components: 1) setting the stage to develop that session's agenda and gather updates; 2) intervention implementation that must include the following steps to coach the parent: a) review the objective, b) use modeling, guided/caregiver practice, or video review to teach the strategy, c) provide specific feedback to the parent, and d) problem solving and plan for next time; steps a-d are repeated for 3-5 activities per session; and 3) summarize plans for parent implementation between sessions. Families are also invited to and guided through the Autism Navigator How-To Guide for Families online course.

Sponsors & Collaborators

• Duquesne University

  collaborator OTHER

• National Institute on Deafness and Other Communication Disorders (NIDCD)

  collaborator NIH

• Florida State University

  lead OTHER

Principal Investigators

• Amy Wetherby, PhD · Florida State University Autism Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

12 Months

Max Age

18 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-07-14

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• United States

Study Locations