PROJECT ABSTRACT
In response to RFA-MH-19-120, the goal of this study is to validate the effectiveness of a new automated online
screening tool—the Social Communication (SoCo) CheckUp—that incorporates empirically-tested screening
items for communication delay and autism spectrum disorder (ASD) in 3-month age intervals. This new screening
tool is designed for universal screening at well-child visits at 9, 12, 15, 18, 21, and 24 months of age to screen
for communication delay and autism. The SoCo CheckUp is part of our Baby Navigator portal, a new mobile
application that includes the SoCo Growth Charts—a developmental surveillance for families to answer
questions about SoCo milestones every 2 months to chart their child’s growth in 5 domains and to explore
hundreds of video clips illustrating early milestones with narration on responsive parenting. Families with a
positive autism screen have links to three ASD-specific tools. We will recruit 4,000 infants by 2 months of age at
one of their first well child visits and invite families to the SoCo Growth Charts for developmental surveillance.
We will then invite families into the portal to screen with the SoCo Checkup based on parent report at 9 months,
with repeat screenings at 12, 15, 18, 21, and 24 months. All families of children with a positive autism screen on
the SoCo Checkup and a comparable number of children with a negative screen will be invited to collect home
observations for an observational screener using the Systematic Observation of Red Flags of ASD (SORF) at
the same ages from 9-24 months. All children with a positive ASD screen on the SORF and a comparable number
of children randomly select with a negative SORF screen will be invited for a confirmatory diagnostic evaluation
at 24 months. We anticipate confirming ASD for least 80 children based on previous research detecting 1/50.
We will address the following research aims: Aim 1. Study psychometric features of the SoCo Checkup cut-
off and composite to diagnostic outcome; Aim 2. Study the trajectories of the SoCo surveillance and screening
to predict autism symptom severity; and Aim 3. Construct a risk algorithm based on multiple parameters to
develop an efficient, cost-effective mobile screening application for use in infants that is readily deployable in the
general population. The expected outcomes of this validation study will demonstrate the effectiveness of an
online surveillance and screening system beginning in the first year of life that will be ready for immediate, rapid,
scalable, and sustainable deployment across the US. Findings will advance science by providing researchers
with a method for recruiting a community sample, allowing for research at younger ages, which could accelerate
genetic, biomedical, and intervention research. The use of innovative technology, user-friendly tools and web-
applications, and implementation science methodology enhances the potential for sustainability and scalability
that can lead to transformative changes to efficiently and effectively screen infants for communication delay and
autism and improve healthcare delivery.
