Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07551752 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Digital Health Parent-Training Intervention for Children With Social Communication Delays

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07551752
Lead Sponsor Florida International University
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Conditions
(from sponsor)
Autism Spectrum Disorder, Social Communication Delay
Related terms Autism Spectrum Disorder
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov