Actively Recruiting
A Digital Health Parent-Training Intervention for Children With Social Communication Delays
Led by Florida International University · Updated on 2026-04-27
100
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
Sponsors
F
Florida International University
Lead Sponsor
N
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Early intervention, during a time of optimal brain plasticity, is critical for autistic children to develop functional skills such as communication and daily living abilities. However, many families face barriers to accessing timely autism-specific services due to delays in autism diagnosis (which is often a prerequisite to autism-specific intervention), long waitlists, high costs, and the necessity to travel far distances to service providers. Self-directed parent-mediated digital health interventions (i.e., programs that parents complete online without provider coaching or feedback) offer a scalable solution to reduce challenges accessing intervention by providing evidence-based strategies that parents can implement without relying on traditional service pathways. The proposed pilot randomized controlled trial (RCT) will test a revised self-directed parent-training program, that teaches parents naturalistic developmental behavioral intervention (NDBI) strategies, which have proven effective for young children with autism. The study will include young children who have already been diagnosed with autism and those who screen positive on an autism screener but have not yet been evaluated, enabling earlier intervention before a formal diagnosis. The study will also explore parents' willingness to engage in the intervention. The specific research aims are: (1) test the preliminary efficacy of the parent-training program vs. treatment as usual (TAU) for 50 children with autism traits and their parents; (2) examine parent engagement in the intervention; and (3) explore predictors of engagement.
CONDITIONS
Official Title
A Digital Health Parent-Training Intervention for Children With Social Communication Delays
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 14 to 48 months
- Children who screen positive on the M-CHAT-R/F or already have a diagnosis of autism
- Parents fluent in English
- Parents agree to complete both study visits and review OPT-In-Early if randomized to the intervention group
- Parents at least 18 years old
- Parents have access to an internet-connected device
You will not qualify if you...
- Children with a neurological condition that would prevent engagement in the intervention or testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Florida International University
Miami, Florida, United States, 33199
Actively Recruiting
Research Team
Y
Yael Dai Dr. Yael Dai, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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