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

Autism Spectrum Disorder Clinical Trial

Official title: Effectiveness Trial of the Early Social Interaction (ESI) Model Using Mobile Technology for Toddlers With Autism Identified From Early Screening in Primary Care

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

• NCT number: NCT05456139
• Study type: Interventional
• Source: Florida State University
• Contact: Sherrie Hajek, MA
• Phone: 850-488-4072
• Email: sherrie.hajek@med.fsu.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Completion date: September 30, 2027