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

April 20, 2026 updated by: Florida International University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yael Dai Dr. Yael Dai, PhD
  • Phone Number: 305-348-1034
  • Email: ydai@fiu.edu

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33199
        • Recruiting
        • Florida International University
        • Contact:
          • Yael Dr. Yael Dai, PhD
          • Phone Number: 917-596-4459
          • Email: ydai@fiu.edu
        • Contact:
        • Principal Investigator:
          • Dr. Yael Dai, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor Imitation Scale
Time Frame: Baseline and 4 months
We will administer a revised Motor Imitation Scale (MIS), a standardized, structured observational measure that assesses a child's ability to imitate familiar and novel motor actions. Children will see 5 actions modeled and then will be prompted to imitate the action using a matching toy. Children are given up to three opportunities to imitate each action. MIS scores range from 0 to 10, with higher scores indicating greater imitation.
Baseline and 4 months
Vineland Scales of Adaptive Behavior-3
Time Frame: Baseline and 4 months
The Vineland Scales of Adaptive Behavior-3 (Vineland-3) is a standardized parent interview measuring adaptive functioning. It will be administered to all participants at pre- and post-treatment to evaluate change occurring in adaptive behavior across groups. Previous research has documented that this measure has robust psychometric properties, is sensitive to change in response to early intervention, and captures dimensions that are highly valued by stakeholders. Higher scores in the Vineland indicate more advanced adaptive skills.
Baseline and 4 months
MacArthur-Bates Communicative Development Inventories (MCDI)
Time Frame: Baseline and 4 months
The MacArthur Bates Communication Development Inventory (MCDI) is a parent-report measure that assesses nonverbal communication (gestures) and verbal communication (words). The Words and Gestures form will be used. The MCDI is widely used, standardized, and validated. It is particularly well-suited for large-scale research due to ease of administration, strong psychometric properties, and sensitivity to individual differences in early language development. Higher scores indicate greater communication.
Baseline and 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Goal Attainment Scaling
Time Frame: Baseline and 4 months
The Goal Attainment Scaling (GAS) is used to evaluate a participant's progress toward a specific, individualized goal. It follows standardized procedures that allow outcomes to be measured on a common metric, making it possible to compare intervention-related change across participants with different goals. Scores ranger from -2 to +2, with higher scores indicating better functioning.
Baseline and 4 months
OPT-In-Early Quiz
Time Frame: Baseline and 4 months
Parent gains in knowledge of OPT-In-Early strategies will be assessed with the OPT-In-Early Quiz, a 30-item multiple-choice quiz that assesses knowledge of NDBI content covered in the OPT-In-Early program. Scores will be based on the percentage of questions that parents answer correctly, with higher scores indicating greater knowledge of intervention content.
Baseline and 4 months
Treatment Evaluation Inventory Short-Form
Time Frame: 4 months
The Treatment Evaluation Inventory Short-Form is a 9-item questionnaire, in which parents rate their acceptability of an intervention on a 5-point Likert scale. Scores are averaged and higher scores represent greater acceptability of the intervention. Parents randomized to the intervention condition will complete this measure at post-treatment.
4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ecological momentary assessment of intervention use and implementation
Time Frame: Ongoing during the 4 months
Parents randomized to the intervention group will complete time-based ecological momentary assessment (EMA). EMA will be used to obtain parent report about whether they (a) reviewed a module (yes/no); (b) practiced learned skill with their child (yes/no); and (c) the duration spent practicing skills with their child (minutes)
Ongoing during the 4 months
Revised Yatchmenoff Client Engagement Scale
Time Frame: Baseline
With the author's permission, we are using a revised version of the Yatchmenoff Client Engagement Scale. Specifically, questions will be included to yield a total receptivity scale score and buy-in scale score. Higher scores will indicate greater parent attitudinal receptiveness and engagement with the intervention. Parents randomized to the intervention group will complete this measure at baseline.
Baseline
Autism Diagnostic Observation Schedule (ADOS-2)
Time Frame: Baseline
The Autism Diagnostic Observation Schedule (ADOS) is a structured, standardized assessment used to evaluate social communication, interaction, play, and restricted or repetitive behaviors associated with Autism Spectrum Disorder. It is widely considered a gold-standard observational measure in both clinical and research settings. We. will administer the ADOS-2 to all children during their baseline visit to assess for autism.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida International University

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-25-0140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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