Mobile Early Social Interaction Coaching for Toddler Autism
(ESI-MC Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications. It is best to consult with the trial coordinators for specific guidance.
What data supports the effectiveness of the treatment Early Social Interaction Mobile Coaching (ESI-MC) for toddler autism?
Research shows that early interventions like the Early Social Interaction model can improve social skills and language development in toddlers with autism. Studies have found that similar treatments, such as the Early Start Denver Model, lead to better social communication and reduced parental stress, highlighting the importance of early, evidence-based interventions.12345
How is the Early Social Interaction Mobile Coaching (ESI-MC) treatment different from other treatments for toddler autism?
The Early Social Interaction Mobile Coaching (ESI-MC) treatment is unique because it focuses on coaching caregivers to actively engage with their toddlers, enhancing social communication skills through a mobile platform, which makes it more accessible and community-friendly compared to traditional in-person therapies.13456
What is the purpose of this trial?
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.
Research Team
Amy Wetherby, PhD
Principal Investigator
Florida State University
Eligibility Criteria
This trial is for toddlers around 18 months old showing early signs of autism, living near one of the eight US recruitment sites. They must have a risk indication for autism from specific assessments and their home's primary language should be English or Spanish. Children with significant motor, visual, or hearing impairments, very low birth weight, medical complications like seizures, or those already in Early Intervention are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Early Social Interaction Mobile Coaching (ESI-MC) via telehealth sessions for 6 months, focusing on parent-implemented interventions for toddlers with ASD.
Follow-up
Participants are monitored for changes in social communication, autism symptoms, and adaptive behavior.
Long-term Follow-up
Exploration of outcomes at 36 months and individual patterns of change from 18-36 months.
Treatment Details
Interventions
- Early Social Interaction Mobile Coaching (ESI-MC)
Early Social Interaction Mobile Coaching (ESI-MC) is already approved in United States for the following indications:
- Autism Spectrum Disorder (ASD) in toddlers
Find a Clinic Near You
Who Is Running the Clinical Trial?
Florida State University
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Children's Healthcare of Atlanta
Collaborator
Weill Medical College of Cornell University
Collaborator
University of Pennsylvania
Collaborator
Seattle Children's Hospital
Collaborator
Seattle Children's Hospital Research Institute
Collaborator
Emory University
Collaborator
Children's Hospital of Philadelphia
Collaborator
University of California, Los Angeles
Collaborator