Autism Spectrum Disorder, Social Communication Delay
Conditions
Keywords
Early intervention, Naturalistic Developmental Behavioral Intervention, Autism Spectrum Disorder, Social Communication Delay, parent training
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.
Interventions
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.
Sponsors
Florida International University
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
14 Months to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor Imitation Scale | 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. |
| Vineland Scales of Adaptive Behavior-3 | 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. |
| MacArthur-Bates Communicative Development Inventories (MCDI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Goal Attainment Scaling | 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. |
| OPT-In-Early Quiz | 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. |
| Treatment Evaluation Inventory Short-Form | 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. |
Countries
United States
Contacts
CONTACTYael Dai Dr. Yael Dai, PhD
Outcome results
None listed