Virtual early intervention for toddlers with autism
Effectiveness Trial of the Early Social Interaction (ESI) Model Using Mobile Technology for Toddlers With Autism Identified From Early Screening in Primary Care
This study is testing a new online program to help toddlers with autism learn social skills and see if starting the program at different ages makes a difference.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 15 Months to 20 Months |
| Sex | All |
| Sponsor | Florida State University Academic / other |
| Locations | 8 sites (Los Angeles, California and 7 other locations) |
| Trial ID | NCT05456139 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of a virtual early intervention platform called Early Social Interaction Mobile Coaching (ESI-MC) for toddlers diagnosed with autism spectrum disorder (ASD). The study will recruit 360 children showing early signs of autism and will assess the impact of starting intervention at different ages (18, 24, or 30 months) using a modified stepped wedge design. Families will participate in individual telehealth sessions that provide coaching and feedback to integrate intervention strategies into daily activities. The trial will be conducted entirely online, from recruitment to intervention, to reach a diverse national sample.
Who should consider this trial
Good fit: Ideal candidates are toddlers aged 18 months with early signs of autism and a clinical diagnosis of ASD.
Not a fit: Patients who do not show early signs of autism or do not meet the diagnostic criteria for ASD may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved developmental outcomes for toddlers with autism by starting evidence-based treatment earlier.
How similar studies have performed: Previous studies have shown promise in using telehealth for early intervention in autism, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Los Angeles, California and 7 other locations
- University of California Los Angeles — Los Angeles, California, United States (Not_yet_recruiting)
- Florida State University Autism Institute — Tallahassee, Florida, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Not_yet_recruiting)
- Rush University — Chicago, Illinois, United States (Not_yet_recruiting)
- Weill Cornell Medical College — White Plains, New York, United States (Not_yet_recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Not_yet_recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- Seattle Children's Hospital — Seattle, Washington, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Amy Wetherby, PhD — Florida State University
- Study coordinator: Sherrie Hajek, MA
- Email: sherrie.hajek@med.fsu.edu
- Phone: 850-488-4072
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.