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Mobile Early Social Interaction Coaching for Toddler Autism (ESI-MC Trial)

N/A
Recruiting
Led By Amy Wetherby, PhD
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3, 6, 9, 12, 15, and 18 months thereafter
Awards & highlights

ESI-MC Trial Summary

This trial will test whether starting evidence-based intervention earlier leads to better outcomes for toddlers with autism than starting later. The study will use a new virtual platform to deliver the intervention and will measure child active engagement and social communication change every 6 months.

Who is the study for?
This trial is for toddlers around 18 months old showing early signs of autism, living near one of the eight US recruitment sites. They must have a risk indication for autism from specific assessments and their home's primary language should be English or Spanish. Children with significant motor, visual, or hearing impairments, very low birth weight, medical complications like seizures, or those already in Early Intervention are excluded.Check my eligibility
What is being tested?
The study tests an all-virtual early intervention called ESI-MC (Early Social Interaction Mobile Coaching) to see if starting treatment earlier improves social communication in toddlers with autism. The program uses telehealth sessions to coach families on integrating interventions into daily activities at different start times: 18, 24, or 30 months.See study design
What are the potential side effects?
Since this trial involves educational and behavioral coaching rather than medication, traditional side effects are not applicable. However, there may be challenges such as stress related to adapting new routines or frustration during learning processes.

ESI-MC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3, 6, 9, 12, 15, and 18 months thereafter
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3, 6, 9, 12, 15, and 18 months thereafter for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intervention Strategy Use
Autistic Disorder
Parent-Child Interaction Change at Home
+1 more
Secondary outcome measures
Adaptive Behavior
Autistic Disorder
Autistic Disorder
+1 more

ESI-MC Trial Design

2Treatment groups
Active Control
Group I: ESI-MC plus Treatment as UsualActive Control1 Intervention
During 1 of the 3 six-month periods of participation, families will receive 24 weekly sessions of Early Social Interaction via Mobile Coaching (ESI-MC) by a trained early intervention provider. ESI-MC is an evidence-based parent-implemented intervention for toddlers with ASD. ESI teaches parents how to support their child's social communication, language, play and behaviors in everyday routines, activities, and places. Program planning entails building consensus with families on priority targets for the child and teaching strategies and supports for the parents using manualized conversational steps, Baby Navigator social communication milestones, and ESI content for families to practice 25 hours per week. Families will be invited to participate in the online Autism Navigator How-To Guide, a self-guided web-based course and companion online group education meetings. Families will also receive Treatment as Usual (TAU).
Group II: Treatment as Usual OnlyActive Control1 Intervention
During 2 of the 3 six-month periods of participation, families will receive Treatment as Usual (TAU) only. Families in the TAU control condition will receive usual care and EI service in their community, which will be tracked with the BSRC Intervention History Form. Because all families join My Baby Navigator and will be screened by the SoCo CheckUp, families in both conditions will have access to the "Seamless Path for Families" which includes online tools about social communication developmental milestones. Families will also have access to Autism Navigator About Autism in Toddlers, the ASD Video Glossary, and the Autism Navigator How-to Guide for Families, a self-guided online course.

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,459 Total Patients Enrolled
81 Trials studying Autism Spectrum Disorder
40,112 Patients Enrolled for Autism Spectrum Disorder
University of PennsylvaniaOTHER
2,005 Previous Clinical Trials
42,881,969 Total Patients Enrolled
15 Trials studying Autism Spectrum Disorder
4,327 Patients Enrolled for Autism Spectrum Disorder
Children's Healthcare of AtlantaOTHER
165 Previous Clinical Trials
104,890 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
190 Patients Enrolled for Autism Spectrum Disorder

Media Library

Early Social Interaction Mobile Coaching (ESI-MC) Clinical Trial Eligibility Overview. Trial Name: NCT05456139 — N/A
Autism Spectrum Disorder Research Study Groups: ESI-MC plus Treatment as Usual, Treatment as Usual Only
Autism Spectrum Disorder Clinical Trial 2023: Early Social Interaction Mobile Coaching (ESI-MC) Highlights & Side Effects. Trial Name: NCT05456139 — N/A
Early Social Interaction Mobile Coaching (ESI-MC) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05456139 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research require participants to be of a certain age?

"This trial is enrolling patients aged between 15 and 20 months old. Additionally, it has 228 trials for minors and 42 trials targeting senior citizens."

Answered by AI

To what extent is participation in this clinical trial expanding?

"This clinical trial necessitates the enrolment of 240 eligible candidates. Rush University in Chicago, Illinois and University of California Los Angeles located in LA are two of many sites offering participation to interested patients."

Answered by AI

What are the stated objectives of this experiment?

"The primary outcome of the clinical trial that will be evaluated at Baseline and 3, 6, 9, 12, 15 and 18 months is Intervention Strategy Use. Secondary outcomes comprise Adaptive Behaviour (measured with VABS-3), Autism Symptoms (assessed by ADOS 2nd edition) and Developmental Level (analyzed through MSEL). Scores range from 1 to 10 for Autism Symptoms while T scores (10 to 90) or Standard scores (40 to 160) are used in other cases; higher values suggesting better performance."

Answered by AI

Could I gain admittance to this medical experiment?

"This trial seeks to recruit 240 individuals with autism spectrum disorder who are between 15 and 20 months old. To be eligible, parents must complete the SoCo CheckUp prior to their child turning 18 months of age; they must also submit a video of them engaging in 6 everyday activities with their child as well as receive a clinical diagnosis based on an ADOS evaluation by the time their kid is 18 (+/-2) months old. Additionally, the family's native language needs to be either English or Spanish and they need to live within 45 miles of one of 8 recruitment sites."

Answered by AI

How numerous are the medical institutions employing this experiment in the urban area?

"This clinical trial is recruiting from an expansive geographical footprint which includes Rush University in Chicago, IL, the University of California Los Angeles in LA, CA and Emory University in Atlanta, GA as well as 8 other sites."

Answered by AI

Are there any openings for volunteers in the current clinical trial?

"Affirmative. The information hosted on clinicaltrials.gov indicates that this trial is actively recruiting participants, having first been posted on August 30th 2022 and last updated the following day. This trial requires 240 individuals to be recruited from 8 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
< 18
What site did they apply to?
University of California Los Angeles
Florida State University Autism Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

When does this trial begin and if so, what would my next steps be if selected?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I’m hopeful in this trial becoming a tool for early intervention with autism. He is 4 and although I would consider him “high functioning” he does have issues socially, does not want to make friends, does not like meeting new people or trying new things.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Effectiveness Trial of Mobile ESI for Toddlers With Autism Identified by Early Screening in Primary Care
Amy M. Wetherby 2023. "Effectiveness Trial of Mobile ESI for Toddlers With Autism Identified by Early Screening in Primary Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05456139.
All > Autism Los Angeles
~160 spots leftby Sep 2026
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