A Digital Health Parent-Training Intervention for Children With Social Communication Delay
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 prerequisi
| Condition(s) | Autism Spectrum Disorder, Social Communication Delay |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 rand |
| Who can participate | 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 |
| Ages | 14 Months |
| Sex | All |
| Lead sponsor | Florida International University |
| Locations | Miami, Florida, United States |
| Start date | 2026-04-11 |
| NCT ID | NCT07551752 |
| Official listing | https://clinicaltrials.gov/study/NCT07551752 |