Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07551752

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

14 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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)

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yael Dai Dr. Yael Dai, PhD

CONTACT

[email protected]

305-348-1034

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Collaborators

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

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 27, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.