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NCT07551752Recruiting

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

Source: ClinicalTrials.gov · Last updated 27 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
20 Apr 2026
Start date
11 Apr 2026
Primary completion date
May 2027
Lead sponsor
Florida International University
Diseases
Autism
NCT number
NCT07551752

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 11 Apr 2026 to the primary completion date, May 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Have a neurological condition that would preclude engagement in the intervention or testing

Other

  • Children:

Who the study is looking for

  • 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

Age in the registry: 14 months to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Florida International University
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.