Online parent-training program teaching naturalistic strategies for toddlers with social communication delays
Official title: A Digital Health Parent-Training Intervention for Children With Social Communication Delays
Run by Florida International University · NCT07551752 · Data updated 2026-11-12
This pilot will test whether a self-directed online parent-training program helps parents teach social-communication skills to children aged 14–48 months who screen positive for autism or have an autism diagnosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 14 Months and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Florida International University Academic / other |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | April 11, 2026 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | April 27, 2026 |
| Trial ID | NCT07551752 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 14–48 months who screen positive on the M-CHAT-R/F or have an autism diagnosis, with a parent or caregiver aged 18+ who is fluent in English and has access to an internet-connected device and can complete two study visits.
✕Probably not a fit
Children with neurological conditions that would prevent engagement in the intervention, families without reliable internet access or non-English-speaking caregivers, and children outside the 14–48 month age range are unlikely to benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot randomized controlled trial will compare a revised self-directed digital parent-training program (OPT‑In‑Early) that teaches Naturalistic Developmental Behavioral Intervention (NDBI) strategies against a comparator condition in families of young children with social communication delays. Parents complete the program online without real-time coaching, and participating children are aged 14–48 months and either screen positive on the M-CHAT-R/F or already have an autism diagnosis. The trial will collect feasibility and usability data from parents and measure child social-communication and functional outcomes at planned study visits. The intervention is intended to reduce barriers to early intervention such as long waitlists, travel, and high costs by providing scalable, evidence-based strategies directly to caregivers.
Why it matters
Potential benefit: If successful, the program could give many families a convenient, lower-cost way to learn evidence-based NDBI strategies that may improve their child's communication and everyday skills during a critical early window.
How similar studies have gone: Parent-mediated NDBI approaches have shown benefits in prior research, while fully self-directed digital parent-training programs are promising but less extensively tested and have produced mixed results to date.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Florida International University
Miami, Florida, United States Recruiting
Study contacts
- Study coordinator: Yael Dai Dr. Yael Dai, PhD
- Email: ydai@fiu.edu
- Phone: 305-348-1034
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.