Digital Health Parent-Training RCT for Autistic Children
ClinicalTrials.gov Studies
Summary
NIH has registered pilot randomized controlled trial NCT07551752, evaluating a self-directed digital health parent-training program (OPT-In-Early) teaching naturalistic developmental behavioral intervention strategies to parents of young children with autism spectrum disorder or social communication delays. The study plans to enroll 50 children, including both those already diagnosed and those screening positive but awaiting formal evaluation, to test preliminary efficacy against treatment as usual and explore parent engagement willingness.
“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.”
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What changed
This document registers a new pilot randomized controlled trial on ClinicalTrials.gov under identifier NCT07551752. The study will evaluate a revised self-directed parent-training program called OPT-In-Early, which teaches parents naturalistic developmental behavioral intervention strategies. The trial will include children with confirmed autism diagnoses and children who screen positive but lack formal evaluation, enabling study of earlier intervention pathways.
For clinical investigators and healthcare providers, this trial represents an emerging evidence base for digital health interventions as scalable alternatives to traditional autism-specific services. The focus on self-directed programs without provider coaching may inform future service-delivery models addressing access barriers including diagnosis delays, waitlists, travel distances, and costs.
Archived snapshot
Apr 27, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Digital Health Parent-Training Intervention for Children With Social Communication Delays
N/A NCT07551752 Kind: NA Apr 27, 2026
Abstract
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...
Conditions: Autism Spectrum Disorder, Social Communication Delay
Interventions: Online Parent Training in Early Behavioral Intervention (OPT-In-Early)
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