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NCT05456139 · ClinicalTrials.gov registry record · NA
Effectiveness Trial of Mobile ESI for Toddlers With Autism Identified by Early Screening in Primary Care
A NA study, sponsored by Florida State University.
- Terminated
- Registry status
- NA
- Development phase
- 52
- Enrollment target
NCT05456139: Clinical Trial NA study, sponsored by Florida State University.
NCT05456139 is a NA study that was terminated before completion, run by Florida State University. The registered enrollment target is 52 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05456139, a NA study, was terminated before completion, sponsored by Florida State University.
- TERMINATED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
Study 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
Primary Outcome
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
Interventions
- BEHAVIORAL Treatment as Usual
- BEHAVIORAL Early Social Interaction Mobile Coaching (ESI-MC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2023-03-15 |
| Est. Completion | 2026-01-31 |
| Phase | NA |
Why NCT05456139 stopped before completion
NCT05456139 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Treatment as Usual is the first listed.
NCT05456139 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05456139 about?
NCT05456139 is a clinical study titled "Effectiveness Trial of Mobile ESI for Toddlers With Autism Identified by Early Screening in Primary Care". 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 Interac...
What is the current status of trial NCT05456139?
This trial is currently terminated. It is a NA study. The enrollment target is 52 participants. The study started on 2023-03-15. Estimated completion is 2026-01-31.
What interventions are being tested in trial NCT05456139?
The interventions under investigation include: Treatment as Usual (BEHAVIORAL), Early Social Interaction Mobile Coaching (ESI-MC) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05456139?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05456139's enrollment target sits among peer trials
52 1272nd of 2000 higher than 722 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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