Recruiting

Parent-Training Program

Sponsor:

Florida International University

Code:

NCT07551752

Conditions

Autism Spectrum Disorder

Social Communication Delay

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT07551752

Start date

Apr 11, 2026

Status verified date

Apr, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • Motor Imitation Scale [ Time Frame: Baseline and 4 months ]
  • Vineland Scales of Adaptive Behavior-3 [ Time Frame: Baseline and 4 months ]
  • MacArthur-Bates Communicative Development Inventories (MCDI) [ Time Frame: Baseline and 4 months ]

Central Contacts and Locations

Central contacts

Yael Dai Dr. Yael Dai, PhD

305-348-1034ydai@fiu.edu

Locations

Florida International University

Recruiting

Miami, Florida, United States, 33199

Contacts

Yael Dr. Yael Dai, PhD

917-596-4459ydai@fiu.edu

Julia M Grobman, B.S.

9547322143jgrobman@fiu.edu

Principal Investigator:

Dr. Yael Dai, PhD

More Information

Sponsor

Florida International University

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Florida International University on 2026-04-27.