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

NCT07551752 | Recruiting

• 1 other identifier: IRB-25-0140
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Autism Spectrum Disorder; Social Communication Delay

Keywords

Early intervention; Naturalistic Developmental Behavioral Intervention; Autism Spectrum Disorder; Social Communication Delay; parent training

Outcome Measures

Primary Outcomes (3)

• Motor Imitation Scale

  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

  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)

  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 Outcomes (3)

• Goal Attainment Scaling

  Baseline and 4 months

• OPT-In-Early Quiz

  Baseline and 4 months

• Treatment Evaluation Inventory Short-Form

  4 months

Other Outcomes (3)

• Ecological momentary assessment of intervention use and implementation

  Ongoing during the 4 months

• Revised Yatchmenoff Client Engagement Scale

  Baseline

• Autism Diagnostic Observation Schedule (ADOS-2)

  Baseline

Study Arms (2)

Treatment as Usual (TAU)

NO INTERVENTION

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)

Treatment (OPT-In-Early) group

EXPERIMENTAL

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)

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.

Treatment (OPT-In-Early) group

Eligibility Criteria

• Age: 14 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Florida International University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

RECRUITING

Related Publications (2)

• Dai YG, Thomas RP, Brennan L, Luu ML, Hughes-Lika J, Reilly M, Moreno P, Obe B, Ahmed KB, Berry LN, Goin-Kochel RP, Helt MS, Barton ML, Dumont-Mathieu T, Robins DL, Fein DA. An initial trial of OPT-In-Early: An online training program for caregivers of autistic children. Autism. 2023 Aug;27(6):1601-1615. doi: 10.1177/13623613221142408. Epub 2022 Dec 15.

  PMID: 36519775 RESULT

• Dai YG, Thomas RP, Brennan L, Helt MS, Barton ML, Dumont-Mathieu T, Fein DA. Development and Acceptability of a New Program for Caregivers of Children with Autism Spectrum Disorder: Online Parent Training in Early Behavioral Intervention. J Autism Dev Disord. 2021 Nov;51(11):4166-4185. doi: 10.1007/s10803-020-04863-z. Epub 2021 Feb 2.

  PMID: 33527164 RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Yael Dai Dr. Yael Dai, PhD

CONTACT

305-348-1034; ydai@fiu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be matched on child age and then randomized to intervention or treatment as usual using block randomization. Allocation will be concealed from the assessor completing post-treatment visits to prevent bias.

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: April 11, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)