Actively Recruiting

Phase Not Applicable
Age: 14Months +
All Genders
NCT07551752

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

Age: 14Months +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Florida International University

Miami, Florida, United States, 33199

Actively Recruiting

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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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