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Virtual coaching for toddlers with autism shows promise but trial cut short

NCT ID NCT05456139

Disease control Sponsor: Florida State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a completely virtual early intervention program for toddlers with autism, using telehealth coaching to help parents embed learning into daily activities. Researchers planned to enroll 240 children from eight US regions, but the trial was terminated early with only 52 participants. The goal was to see if starting coaching earlier (at 18, 24, or 30 months) leads to better social communication and developmental outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Early Social Interaction Mobile Coaching (ESI-MC) via telehealth
What this could lead to
If successful, this approach could provide a scalable, virtual early intervention for toddlers with autism, improving social communication and developmental outcomes, especially in underserved communities.
What could go wrong
The trial was terminated early with only 52 participants, so results are limited. It is unclear if the intervention works better than usual care, and the virtual format may not suit all families.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

52 people

The number who actually took part.

Started

Mar 2023

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 to 20 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism spectrum disorder

Contacts and locations

Locations

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19149, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Emory University

    Atlanta, Georgia, 30329, United States

  • Florida State University Autism Institute

    Tallahassee, Florida, 32309, United States

  • Rush University

    Chicago, Illinois, 60612, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98145, United States

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • Weill Cornell Medical College

    White Plains, New York, 10605, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.