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

Part of paid clinical trials in Miami, Florida.

Sponsor
Florida International University
Study ID
NCT07551752
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
14 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • Online Parent Training in Early Behavioral Intervention (OPT-In-Early) — BEHAVIORAL
    OPT-In-Early is an online 14-module self-directed naturalistic developmental behavioral intervention (NDBI) that uses simple text, narration, and interspersed videos to teach parents how to increase their children's social engagement, communication, adaptive behaviors, and reduce challenging behaviors.

Study Details

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.

Key Dates

Start date
Apr 11, 2026
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Treatment as Usual (TAU)
    This arm will complete treatment as usual during the 4 months of the study. Specifically, if the family is receiving any intervention, they will continue to receive it. Once the post-treatment study visit is completed, they will be granted access to the intervention being studied (OPT-In-Early)
  • Experimental: Treatment (OPT-In-Early) group
    The intervention group will receive access to OPT-In-Early. OPT-In-Early is an online 14-module self-directed parent-training program that uses simple text, narration, and interspersed videos to teach parents how to increase their children's social engagement, communication, adaptive behaviors, and reduce challenging behaviors.

Primary Outcome Measure

Motor Imitation Scale [ Time Frame: Baseline and 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Florida International UniversityMiamiFlorida33199
Yael Dr. Yael Dai, PhD
[email protected]
917-596-4459
Julia M Grobman, B.S.
[email protected]
9547322143
Dr. Yael Dai, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Florida International University· Miami, FL

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