Actively Recruiting

Phase Not Applicable
Age: 14Months +
All Genders
ID07551752

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

Led by Florida International University · Updated on 2026-04-27

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

F

Florida International University

Lead Sponsor

N

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a self-directed, online parent-training program designed to help young children with autism spectrum disorder or social communication delays develop important skills during a critical period of brain development. This pilot randomized controlled trial will compare the effects of this digital intervention to treatment as usual, aiming to support families facing challenges like diagnosis delays, long waitlists, and limited access to services. The study also explores how willing parents are to engage with the program to improve their children's communication and daily living abilities. The study includes two groups: one will continue their usual care, and the other will use the OPT-In-Early program, which consists of 14 online modules featuring text, narration, and videos that teach parents naturalistic developmental behavioral intervention strategies. These strategies focus on increasing children's social engagement, communication, adaptive behaviors, and reducing challenging behaviors. Families in the usual care group will get access to the program after completing the study. Participants will be assessed at the start and after four months using measures such as the Motor Imitation Scale, Vineland Scales of Adaptive Behavior-3, and the MacArthur-Bates Communicative Development Inventories. Additional assessments include goal attainment, quizzes on the program content, and treatment evaluations. Parents must complete two study visits and have internet access to participate. The total study duration for each child and parent is four months, during which researchers will monitor progress and parent engagement.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 14Months +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 14 to 48 months
  • Children who screen positive on the M-CHAT-R/F or already have a diagnosis of autism
  • Parents who are fluent in English
  • Parents who agree to complete both study visits and review OPT-In-Early if randomized to the intervention group
  • Parents who are at least 18 years old
  • Parents who have access to an internet-connected device
Not Eligible

You will not qualify if you...

  • Children who have a neurological condition that would prevent participation in the intervention or testing

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 4 months

Participants randomized to the intervention group will complete the 14-module online parent-training program (OPT-In-Early) over 4 months. Participants in the usual care group will continue their current interventions during this period.

1 baseline visit and 1 follow-up visit

Trial Site Locations

Total: 1 location

1

Florida International University

Miami, Florida, United States, 33199

Actively Recruiting

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Research Team

Y

Yael Dai Dr. Yael Dai, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Development and Acceptability of a New Program for Caregivers of Children with Autism Spectrum Disorder: Online Parent Training in Early Behavioral Intervention.

Yael G Dai, Rebecca P Thomas, Lynn Brennan...

https://pubmed.ncbi.nlm.nih.gov/33527164