240 Participants Needed

Mobile Early Social Interaction Coaching for Toddler Autism

(ESI-MC Trial)

Recruiting at 7 trial locations
SH
AW
Overseen ByAmy Wetherby, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Florida State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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

AW

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

My primary home language is either English or Spanish.
My child can sit up, reach for things, and show or give objects.
My child's SoCo CheckUp by 18 months showed a risk for autism.
See 5 more

Exclusion Criteria

Enrollment in EI at the time of screening
Child does not meet diagnostic criteria for autism
My family and I do not consent to video recording.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

6 months
24 weekly sessions (virtual)

Follow-up

Participants are monitored for changes in social communication, autism symptoms, and adaptive behavior.

12 months
Periodic assessments at 6, 12, and 18 months

Long-term Follow-up

Exploration of outcomes at 36 months and individual patterns of change from 18-36 months.

18 months

Treatment Details

Interventions

  • Early Social Interaction Mobile Coaching (ESI-MC)
Trial Overview The study tests an all-virtual early intervention called ESI-MC (Early Social Interaction Mobile Coaching) to see if starting treatment earlier improves social communication in toddlers with autism. The program uses telehealth sessions to coach families on integrating interventions into daily activities at different start times: 18, 24, or 30 months.
Participant Groups
2Treatment groups
Active Control
Group I: Treatment as Usual OnlyActive Control1 Intervention
During 2 of the 3 six-month periods of participation, families will receive Treatment as Usual (TAU) only. Families in the TAU control condition will receive usual care and EI service 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.
Group II: ESI-MC plus Treatment as UsualActive Control1 Intervention
During 1 of the 3 six-month periods of participation, families will receive 24 weekly sessions of Early Social Interaction via Mobile Coaching (ESI-MC) by a trained early intervention provider. ESI-MC is an evidence-based parent-implemented intervention for toddlers with ASD. ESI teaches parents how to support their child's social communication, language, play and behaviors in everyday routines, activities, and places. Program planning entails building consensus with families on priority targets for the child and teaching strategies and supports for the parents using manualized conversational steps, Baby Navigator social communication milestones, and ESI content for families to practice 25 hours per week. Families will be invited to participate in the online Autism Navigator How-To Guide, a self-guided web-based course and companion online group education meetings. Families will also receive Treatment as Usual (TAU).

Early Social Interaction Mobile Coaching (ESI-MC) is already approved in United States for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Early Social Interaction Mobile Coaching for:
  • Autism Spectrum Disorder (ASD) in toddlers

Find a Clinic Near You

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials
234
Recruited
41,100+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Children's Healthcare of Atlanta

Collaborator

Trials
172
Recruited
108,000+

Weill Medical College of Cornell University

Collaborator

Trials
1,103
Recruited
1,157,000+

University of Pennsylvania

Collaborator

Trials
2,118
Recruited
45,270,000+

Seattle Children's Hospital

Collaborator

Trials
319
Recruited
5,232,000+

Seattle Children's Hospital Research Institute

Collaborator

Trials
2
Recruited
720+

Emory University

Collaborator

Trials
1,735
Recruited
2,605,000+

Children's Hospital of Philadelphia

Collaborator

Trials
749
Recruited
11,400,000+

University of California, Los Angeles

Collaborator

Trials
1,594
Recruited
10,430,000+

Findings from Research

The Early Social Interaction (ESI) model, tested in a randomized controlled trial with 82 toddlers with autism spectrum disorder (ASD), is the only parent-implemented intervention that showed significant improvements in child outcomes like social communication and adaptive behavior.
A new measure of active engagement was sensitive to changes within just 3 months and could predict improvements in standardized child outcome measures, highlighting the importance of parent involvement in natural settings for effective intervention.
Changing Developmental Trajectories of Toddlers With Autism Spectrum Disorder: Strategies for Bridging Research to Community Practice.Wetherby, AM., Woods, J., Guthrie, W., et al.[2020]
A synthesis of 66 studies involving 513 participants indicates that various interventions can effectively enhance social behavior in individuals with autism, highlighting the importance of tailored approaches based on age and delivery method.
Social skills groups have been classified as an established evidence-based practice (EBP), while video modeling is recognized as a promising EBP, suggesting these methods are particularly effective in addressing social deficits in autism.
Social skills interventions for individuals with autism: evaluation for evidence-based practices within a best evidence synthesis framework.Reichow, B., Volkmar, FR.[2021]
In a study involving 59 young children with Autism Spectrum Disorder (ASD), a tablet-based intervention did not show significant improvements in most skills compared to standard therapy, except for expressive language.
However, when looking at all participants together over time, there were notable improvements in receptive and pragmatic language as well as social skills, indicating that the intervention may support skill acquisition in these areas.
A Randomised Controlled Trial of an Information Communication Technology Delivered Intervention for Children with Autism Spectrum Disorder Living in Regional Australia.Parsons, D., Cordier, R., Lee, H., et al.[2020]

References

Changing Developmental Trajectories of Toddlers With Autism Spectrum Disorder: Strategies for Bridging Research to Community Practice. [2020]
Social skills interventions for individuals with autism: evaluation for evidence-based practices within a best evidence synthesis framework. [2021]
A Randomised Controlled Trial of an Information Communication Technology Delivered Intervention for Children with Autism Spectrum Disorder Living in Regional Australia. [2020]
Effects of Parent-Implemented Early Start Denver Model Intervention on Chinese Toddlers with Autism Spectrum Disorder: A Non-Randomized Controlled Trial. [2022]
Mutual Gaze: An Active Ingredient for Social Development in Toddlers with ASD: A Randomized Control Trial. [2021]
Brief Report: Assessment of a Caregiver-Implemented Intervention for Improving Social Communication Skills in Toddlers and Young Children with Autism. [2022]
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