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

NCT ID: NCT05456139

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

This is a collaborative R01 application (RFA-MH-18-700) with Dr. Amy Wetherby as PI at Florida State University (FSU), Drs. Ami Klin and Jennifer Stapel-Wax as Co-PIs at Emory University (EU), and Dr. Catherine Lord as Co-PI at the University of California, Los Angeles (UCLA). This effectiveness trial will address the important question of whether starting evidence-based intervention earlier leads to better outcomes than starting later. The investigators will compare the timing of Early Social Interaction Mobile Coaching (ESI-MC) -individual telehealth sessions with coaching and feedback to help families embed intervention in everyday activities, starting at 18, 24, or 30 months, with a modified stepped wedge design and blended implementation research. This effectiveness trial will be conducted using a virtual platform from recruitment through intervention implementation to reach a national community-based sample of toddlers with autism spectrum disorder (ASD).

Overview of Effectiveness Trial. The investigators will recruit 360 children with early signs of autism at 18 months using a new virtual platform-My Baby Navigator-linking surveillance and screening tools, an app for uploading video-recorded home observations and mobile intervention sessions, and a package of educational resources. From the pool of 360 children with early signs, the investigators will identify 240 children with a clinical best estimate diagnosis of ASD, 60 in each of four regions (Northeast, Southeast, Midwest, West Coast), and randomly assign parent-child dyads to one of three ESI-MC timing groups (18, 24, 30) to address the following research aims:

Aim 1. Compare the effectiveness of ESI-MC implemented for 6 months on proximal outcome measures of child active engagement, child social communication change, parent transactional supports, and parent evidence-based strategy use (1A) with Treatment-as-Usual (TAU) at 24 and 30 months and (1B) across treatment timing groups initiated at 18, 24, or 30 months. Hypotheses 1) Parent-child dyads in ESI-MC will (1A) show significantly better child and parent outcomes compared to TAU and (1B) those starting ESI-MC earlier will show successively better child outcomes than those starting later.

Aim 2. Examine (2A) change in parent transactional supports and evidence-based strategy use as the mechanism for change in proximal child outcomes and (2B) individual child and family characteristics that moderate response to treatment.

Aim 3. Compare the effectiveness of ESI-MC implemented for 6 months on secondary outcome measures of child developmental level, autism symptoms, and adaptive behavior (3A) with TAU at 24 and 30 months and (3B) across treatment timing groups initiated at 18, 24, or 30 months.

Aim 4. Explore outcomes at 36 months, individual patterns of change from 18-36 months, and predictors of change across treatment timing groups by estimating child growth trajectories.

Aim 5. Examine barriers and promotive factors impacting widespread dissemination, implementation and sustainability across racial, socioeconomic and geographic lines, including parental uptake, engagement and satisfaction during and after intervention, treatment fidelity, reduction of disparities in access to services and in outcomes, and cost-benefit analyses.

The investigators expect ESI-MC will result in better outcomes than TAU and that initiating treatment earlier leads to better outcomes. This effectiveness trial of ESI-MC will address concerns raised by the US Preventive Services Task Force (USPSTF), advance knowledge for community-uptake, and provide needed evidence to support early universal screening and referral at 18-24 months. Documenting the therapeutic value of ESI-MC to teach parents in natural environments will offer a community-viable and affordable treatment to improve services for toddlers with ASD, which in light of ongoing COVID-19 pandemic restrictions, places a premium on remote tools and methods. The recent spotlight on healthcare disparities and civil injustices underscores the urgency with which inequalities faced by minority and low-resource communities need to be vigorously addressed. By maximizing the use of mobile technology and community-based care teams, this treatment will be ready for immediate, rapid, scalable, and sustainable deployment across the US that can lead to transformative changes in healthcare services for toddlers with autism and their families.

Overview of Collaborative Study. A collaborative study is necessary to accommodate a large, representative community-based sample of very young children with ASD with geographic spread for an effectiveness trial. Recruitment and implementation across 8 sites in 4 national regions will provide racial/ethnic and socioeconomic diversity, ample urban/rural areas, and different health service systems. The research team includes the complementary expertise needed and has history of collaboration. The PIs will establish a means of coordinating communication and shared decision-making before the start of research. FSU will provide the virtual platform for recruitment and random assignment, train the ESI mobile coaches, monitor intervention fidelity, and oversee data management and statistical analysis. UCLA will oversee reliability of autism symptom measures and calibration of diagnosis. Emory will oversee documentation and dissemination of research-based solutions to address health disparities. Each site will conduct diagnostic evaluations, ensure reliability on measures, and use manualized procedures conducted with fidelity to ensure scientific integrity for pooling data.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Treatment as Usual Only

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 Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: BEHAVIORAL

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.

ESI-MC plus Treatment as Usual

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).

Group Type: ACTIVE_COMPARATOR

Early Social Interaction Mobile Coaching (ESI-MC)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Parent(s) complete the SoCo CheckUp by the time the child is 18 months of age and results will indicate positive risk for autism
• Parent(s) submit a home observation video of the parent engaging their child for an hour in 6 everyday activities by the time the child is 18 months of age
• Results of the SORF rated from the home observation indicate risk for autism
• The child receives a clinical best estimate diagnosis of autism spectrum disorder based on a diagnostic and developmental evaluation by 18 months (+/-2 months) of age, which includes completion of the ADOS
• The child will have sufficient trunk stability and control of arm and hand movements to hold objects and make simple gestures (give, show, reach)
• Parent(s) agree to be in the intervention study by the time the child is 18 months (+/- 2 months) of age
• The primary language at home is English or Spanish (the SoCo CheckUp and all Baby Navigator tools are available in these languages)
• The family lives within 45 miles of one of the 8 recruitment sites.

Exclusion Criteria

• Child does not meet diagnostic criteria for autism
• Family does not agree to be video recorded
• Family does not agree to receive the intervention via mobile technology
• Enrollment in EI at the time of screening
• A sibling is already enrolled in the trial
• Children with significant motor, visual, or hearing impairments
• Children born with very low birth weight or significant medical complications (e.g., seizure disorder)

• Minimum Eligible Age: 15 Months
• Maximum Eligible Age: 20 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Amy M. Wetherby

Distinguished Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Wetherby, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

University of California Los Angeles

Los Angeles, California, United States

Florida State University Autism Institute

Tallahassee, Florida, United States

Emory University

Atlanta, Georgia, United States

Rush University

Chicago, Illinois, United States

Weill Cornell Medical College

White Plains, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Seattle Children's Hospital

Seattle, Washington, United States

Countries

United States

Related Links

https://www.babynavigator.com

Baby Navigator

https://www.autismnavigator.com

Autism Navigator

Other Identifiers

R01MH121627

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01MH121622

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01MH127120

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002656

Identifier Type: -

Identifier Source: org_study_id