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

NCT05456139 | Terminated DMC

• 4 other identifiers: STUDY00002656R01MH121627R01MH121622R01MH127120
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 8

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.

Conditions

Autism Spectrum Disorder

Keywords

Pediatrics; Telehealth; Treatment; Early Intervention; Community-based

Outcome Measures

Primary Outcomes (4)

• Parent-Child Interaction Change at Home

  Parent use of responsive learning strategies and child active engagement will be periodically assessed using the Measure of Active Engagement and Transactional Supports (MAETS). The MAETS is a rating of a video-recorded home observation of parent-child interaction during everyday activities. The MAETS includes 8 components: participation and a productive role; predictable activities; language that follows the child's focus of attention; child initiations; balance of communicative turns; messages to support child comprehension; verbal and nonverbal models; and appropriate expectations and demands. Each component is scored on a 4-point scale where 0 = Absent, 1 = Emerging, 2 = Practicing, and 3 = Mastery. Total scores range from 0 to 32 and higher scores indicate that the level of parent support is better.

  Baseline and 3, 6, 9, 12, 15, and 18 months thereafter

• Social Communication Change

  The Brief Observation of Social Communication Change (BOSCC) is designed to measures change during treatment in social communication behaviors in young children with ASD. The BOSCC will be coded from a standardized 10-minute video observations of free-play interactions between the child and caregiver collected during clinical assessments.

  Baseline and 6, 12, and 18 months thereafter

• Intervention Strategy Use

  The Measure of NDBI Strategy Implementation-Caregiver Change (MONSI-CC) measures changes in caregivers' use of core NDBI strategies during parent-mediated early interventions. The MONSI-CC will be independently coded from the same standardized 10-minute parent-child interaction collected as part of the BOSCC and will be examined as a possible mediator of change in BOSCC outcomes.

  Baseline and 6, 12, and 18 months thereafter

• Observation of Diagnostic Features of Autism Change

  Features of autism spectrum disorder (ASD) will be periodically measured using the Systematic Observation of Red Flags (SORF) of ASD. The SORF is measured from a home observation of everyday activities. The SORF includes 11 red flags in social communication and social interaction and 11 red flags in restricted and repetitive behaviors using the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) diagnostic features rated on a 3 point scale. The total number of red flags ranges from 0 to 22 and higher scores indicate more red flags of ASD. The total composite score ranges from 0 to 66 and higher scores indicate more diagnostic features of ASD.

  Baseline and 3, 6, 9, 12, 15, and 18 months thereafter

Secondary Outcomes (4)

• Autism Symptoms

  Baseline and 6, 12, and 18 months thereafter

• Developmental Level

  Baseline and 6, 12, and 18 months thereafter

• Adaptive Behavior

  Baseline and 6, 12, and 18 months thereafter

• Brief Observation of Autism Symptoms

  Baseline and 6, 12, and 18 months thereafter

Study Arms (2)

Treatment as Usual Only

ACTIVE COMPARATOR

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.

Behavioral: Treatment as Usual

ESI-MC plus Treatment as Usual

ACTIVE COMPARATOR

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).

Behavioral: Early Social Interaction Mobile Coaching (ESI-MC)

Interventions

Treatment as Usual 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.

Treatment as Usual Only

Early Social Interaction Mobile Coaching (ESI-MC) 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.

ESI-MC plus Treatment as Usual

Eligibility Criteria

• Age: 15 Months - 20 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Florida State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (8)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Florida State University Autism Institute

Tallahassee, Florida, 32309, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

Weill Cornell Medical College

White Plains, New York, 10605, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19149, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98145, United States

Location

Related Links

• Baby Navigator
• Autism Navigator

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Amy Wetherby, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Investigator and diagnosticians will be kept blind to treatment arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Research Professor

Model Details: The investigators will conduct an effectiveness trial of ESI-MC to address the 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. he investigators will diagnostically ascertain 240 children from a pool of 360 18-month-olds with early signs of autism. The 240 children will be randomly assigned to one of three ESI-MC timing groups. 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.

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 13, 2022
• Study Start: March 15, 2023
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (8)