Telehealth Parent-Led Early Intervention for Infants Showing Early Signs of Autism Spectrum Disorder A Multisite Randomized Trial Evaluating Development, Symptoms, and Brain Changes

What this Trial Is About

Autism Spectrum Disorder ASD is a complex condition marked by challenges in social communication and repetitive behaviors, often accompanied by various physical, mental, and developmental issues. Early signs usually appear in the first year of life, including reduced social attention and unusual object use. Early interventions for infants showing these signs may improve development, reduce symptoms, and lessen caregiver stress. This research aims to assess FIRRST, a parent-led telehealth intervention, in a randomized trial with 132 infants aged 9 to 14 months showing early ASD signs, to improve developmental and brain outcomes compared to parent education alone. The study compares two groups one receiving FIRRST, which is based on natural developmental behavioral principles targeting early ASD signs and motor skills through parent involvement and tailored activities, delivered by trained professionals via telehealth and a control group receiving written educational materials and monthly counseling to support family well-being. The intervention lasts 24 weeks, followed by a 24-week follow-up period after the intervention ends. Participants will undergo assessments at three points baseline, after 24 weeks of intervention, and 24 weeks post-intervention. Evaluations include infant development, ASD symptoms, brain activity through EEG, parent mental health, and parent-child interactions. The trial monitors changes over a year to understand the effects of early telehealth intervention on infants at risk for ASD and their families.

Telehealth Intervention for Infants With Prodromes of ASD