NCT07551752 A Digital Health Parent-Training Intervention for Children With Social Communication Delays
| NCT ID | NCT07551752 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Florida International University |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-04-11 |
| Primary Completion | 2027-05 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Children: * aged 14 - 48 months * screen positive on the M-CHAT-R/F or already have a diagnosis of autism * Parents: * Fluent in English * Agree to complete both study visits and review OPT-In-Early if randomized to the intervention group * At least 18 years old * Have access to an internet-connected device Exclusion Criteria: * Children: * Have a neurological condition that would preclude engagement in the intervention or testing