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

NCT07551752 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Online Parent Training in Early Behavioral Intervention (OPT-In-Early)

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.

Sponsors & Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH

  • Florida International University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-11
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07551752 on ClinicalTrials.gov