Your session is about to expire
← Back to Search
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
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 3, 6, 9, 12, 15, and 18 months thereafter
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3, 6, 9, 12, 15, and 18 months thereafter
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Intervention Strategy Use
Autistic Disorder
Parent-Child Interaction Change at Home
+1 moreSecondary study objectives
Adaptive Behavior
Autistic Disorder
Autistic Disorder
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: 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.
Group II: 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).
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,933 Previous Clinical Trials
2,745,798 Total Patients Enrolled
84 Trials studying Autism Spectrum Disorder
41,012 Patients Enrolled for Autism Spectrum Disorder
Children's Healthcare of AtlantaOTHER
169 Previous Clinical Trials
106,878 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
190 Patients Enrolled for Autism Spectrum Disorder
Weill Medical College of Cornell UniversityOTHER
1,091 Previous Clinical Trials
1,154,506 Total Patients Enrolled
7 Trials studying Autism Spectrum Disorder
11,155 Patients Enrolled for Autism Spectrum Disorder
University of PennsylvaniaOTHER
2,084 Previous Clinical Trials
42,726,808 Total Patients Enrolled
15 Trials studying Autism Spectrum Disorder
4,327 Patients Enrolled for Autism Spectrum Disorder
Seattle Children's Hospital Research InstituteUNKNOWN
1 Previous Clinical Trials
482 Total Patients Enrolled
Florida State UniversityLead Sponsor
224 Previous Clinical Trials
36,495 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
11,176 Patients Enrolled for Autism Spectrum Disorder
Emory UniversityOTHER
1,708 Previous Clinical Trials
2,607,258 Total Patients Enrolled
23 Trials studying Autism Spectrum Disorder
21,347 Patients Enrolled for Autism Spectrum Disorder
Children's Hospital of PhiladelphiaOTHER
731 Previous Clinical Trials
8,472,594 Total Patients Enrolled
10 Trials studying Autism Spectrum Disorder
9,254 Patients Enrolled for Autism Spectrum Disorder
University of California, Los AngelesOTHER
1,568 Previous Clinical Trials
10,314,032 Total Patients Enrolled
25 Trials studying Autism Spectrum Disorder
4,159 Patients Enrolled for Autism Spectrum Disorder
Children's Hospital Medical Center, CincinnatiOTHER
839 Previous Clinical Trials
6,565,363 Total Patients Enrolled
26 Trials studying Autism Spectrum Disorder
10,677 Patients Enrolled for Autism Spectrum Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My primary home language is either English or Spanish.My child can sit up, reach for things, and show or give objects.My child's SoCo CheckUp by 18 months showed a risk for autism.I have submitted a video of me engaging with my child in daily activities.My family and I do not consent to video recording.My child's parent(s) agree to join the study before my child turns 20 months old.My child was born with a very low birth weight or had serious health issues.My child was diagnosed with autism before 20 months old, including an ADOS test.My child has major difficulties with movement, seeing, or hearing.My family and I do not want to use mobile technology for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment as Usual Only
- Group 2: ESI-MC plus Treatment as Usual
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.