Florida International University
Miami, Florida, 33199, United States
Location status: Recruiting
Location contact
Dr. Yael Dai, PhD
PRINCIPAL_INVESTIGATOR
Julia M Grobman, B.S.
CONTACT
Yael Dr. Yael Dai, PhD
CONTACT
NCT Number: NCT07551752
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.
Interested in participating?
Request Info14 month and older
All sexes
Interventional
Not applicable
Miami, Florida, 33199, United States
Location status: Recruiting
Dr. Yael Dai, PhD
PRINCIPAL_INVESTIGATOR
Julia M Grobman, B.S.
CONTACT
Yael Dr. Yael Dai, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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)
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.
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.
Contact information is provided by the study sponsor or research team.
Florida International University
Other
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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.
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