Online parent-training program teaching naturalistic strategies for toddlers with social communication delays
A Digital Health Parent-Training Intervention for Children With Social Communication Delays
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 14 Months and up |
| Sex | All |
| Sponsor | Florida International University Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT07551752 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Miami, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.