Effectiveness Trial of Mobile ESI for Toddlers With Autism Identified by Early Screening in Primary Care

Summary

The goal of this collaborative R01 is to demonstrate the therapeutic value and community-wide implementability of an early intervention (EI) platform for toddlers with autism spectrum disorder (ASD) that is completely virtual, from recruitment through intervention. This platform-Early Social Interaction Mobile Coaching (ESI-MC) deploys individual telehealth sessions with coaching and feedback to help families embed intervention in everyday activities. Specifically, the investigators will conduct an effectiveness trial of ESI-MC to address the important question of whether starting evidence-based intervention earlier leads to better outcomes than starting later. The investigators will address this question by using a modified stepped wedge design and blended implementation research to analyze data obtained with ESI-MC start at 18, 24, or 30 months. The investigators will diagnostically ascertain 240 children from a pool of 360 18-month-olds with early signs of autism, 30 in each of 8 US regions (Central and SW Florida; Atlanta, GA; suburbs of Philadelphia, PA; New York City, NY; Cincinnati, OH; Chicago, IL; Seattle, WA; and Los Angeles, CA). Research participants will be recruited using a new virtual platform-My Baby Navigator-linking a new surveillance and screening tool, an app to upload video-recorded home observations and telehealth intervention sessions, and a package of educational resources. The 240 children will be randomly assigned to one of three ESI-MC timing groups. ESI-MC will be delivered by community-based early intervention providers (EIPs) currently working within the the early intervention system in the recruitment regions. The investigators will measure child active engagement and social communication change every 6 months as the primary outcome variables. Outcome measures of developmental level, autism symptoms, and adaptive behavior will be examined to measure differential treatment effects. Maximizing the use of mobile technology, ESI-MC offers the prospect of a community-viable, scalable and sustainable treatment to improve EI services for toddlers with ASD, particularly among minority and low-resource communities.

Conditions

• Autism Spectrum Disorder

Interventions

BEHAVIORAL

Treatment as Usual

Families in the Treatment as Usual (TAU) condition will receive usual care and EI services in their community, which will be tracked with the BSRC Intervention History Form. Because all families join My Baby Navigator and will be screened by the SoCo CheckUp, families in both conditions will have access to the "Seamless Path for Families" which includes online tools about social communication developmental milestones. Families will also have access to Autism Navigator About Autism in Toddlers, the ASD Video Glossary, and the Autism Navigator How-to Guide for Families, a self-guided online course.

BEHAVIORAL

Early Social Interaction Mobile Coaching (ESI-MC)

The ESI-MC coach will offer 24 weekly sessions for the 6-month ESI-MC condition. The parent will be the focus of training. Each session includes: setting the stage to develop that session's agenda; intervention implementation with these coaching steps: a) review the target, b) use guided/caregiver practice, or video review to teach the strategy, c) provide specific feedback to support caregiver reflection and independence in the activity, and d) problem solving and plan for next time; steps a-d are repeated for 3-5 activities per session; and summarize plans for deliberate practice between sessions. Families will be invited to participate in the online Autism Navigator How-To Guide, a self-guided online course and companion to the online group education meetings to engage families in the content of the online course and provide support through interaction with other families. Families will also participate in TAU usual care and EI services in their community.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Florida State University

  lead OTHER

Principal Investigators

• Amy Wetherby, PhD · Florida State University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

15 Months

Max Age

20 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-15

Primary Completion

2026-01-31

Completion

2026-01-31

Countries

• United States

Study Locations