NCT05456139Terminated
Effectiveness Trial of Mobile ESI for Toddlers With Autism Identified by Early Screening in Primary Care
Effectiveness Trial of the Early Social Interaction (ESI) Model Using Mobile Technology for Toddlers With Autism Identified From Early Screening in Primary Care
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Reason given: NIMH determined that the grant was not feasible due to lack of sufficient participant recruitment and negotiated a bilateral termination of this grant on 04/01/2025. Recruitment was halted and an orderly phase-out plan was approved and implemented.
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 11 Jul 2022
- Start date
- 15 Mar 2023
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Florida State University
- Diseases
- Autism
- NCT number
- NCT05456139
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Children born with very low birth weight or significant medical complications (e.g., seizure disorder)
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 15 months to 20 months · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University | Atlanta | United States | Unknown status |
| RUSH University | Chicago | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center | Cincinnati | United States | Unknown status |
| University of California, Los Angeles | Los Angeles | United States | Unknown status |
| Children's Hospital of Philadelphia | Philadelphia | United States | Unknown status |
| Seattle Children's Hospital | Seattle | United States | Unknown status |
| Florida State University Autism Institute | Tallahassee | United States | Unknown status |
| Weill Cornell Medical College | White Plains | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.