Mobile Early Social Interaction Coaching for Toddler Autism

(ESI-MC Trial)

Recruiting at 7 trial locations

Overseen By Amy Wetherby, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: No autism, Motor impairments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

Duration: 6 months

240 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 2 4 5 6}

Who Is on the Research Team?

Amy Wetherby, PhD

Principal Investigator

Florida State University

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Treatment as Usual Only Active Control 1 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 Usual Active Control 1 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:

Approved in United States as Early Social Interaction Mobile Coaching for:

• Autism Spectrum Disorder (ASD) in toddlers

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The 26-week parent-implemented Early Start Denver Model (P-ESDM) intervention significantly improved developmental outcomes, particularly in language skills and social communication, for toddlers with autism spectrum disorder (ASD) in China, compared to a community group receiving standard interventions.

Parents of children in the P-ESDM group reported decreased parenting stress, suggesting that this intervention not only benefits the children but also supports parents in managing the challenges associated with raising a child with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Parent-Implemented Early Start Denver Model Intervention on Chinese Toddlers with Autism Spectrum Disorder: A Non-Randomized Controlled Trial. Zhou, B., Xu, Q., Li, H., et al.[2022]

The Pathways intervention, which includes a mutual gaze component, significantly improved social measures, communicative synchrony, and adaptive functioning in children compared to standard services-as-usual (SAU) over a 12-week period with 78 families involved.

Mutual gaze was identified as an important factor contributing to social and communication development, highlighting its potential role in early childhood interventions for autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mutual Gaze: An Active Ingredient for Social Development in Toddlers with ASD: A Randomized Control Trial. Rollins, PR., De Froy, A., Campbell, M., et al.[2021]

A 4-week intervention involving caregiver coaching for eight toddlers aged 21 to 45 months showed improvements in social communication and language development, indicating its potential effectiveness.

The study also highlighted that caregivers gained knowledge and felt more engaged with their toddlers, suggesting that parental involvement is key to enhancing developmental outcomes in children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: Assessment of a Caregiver-Implemented Intervention for Improving Social Communication Skills in Toddlers and Young Children with Autism. Rouhandeh, AA., Honsberger, C., Shanok, NA., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Changing Developmental Trajectories of Toddlers With Autism Spectrum Disorder: Strategies for Bridging Research to Community Practice. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Social skills interventions for individuals with autism: evaluation for evidence-based practices within a best evidence synthesis framework. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A Randomised Controlled Trial of an Information Communication Technology Delivered Intervention for Children with Autism Spectrum Disorder Living in Regional Australia. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of Parent-Implemented Early Start Denver Model Intervention on Chinese Toddlers with Autism Spectrum Disorder: A Non-Randomized Controlled Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Mutual Gaze: An Active Ingredient for Social Development in Toddlers with ASD: A Randomized Control Trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Brief Report: Assessment of a Caregiver-Implemented Intervention for Improving Social Communication Skills in Toddlers and Young Children with Autism. [2022]