Identifying brain markers for treatment response in young children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot investigation aims to identify neuroimaging biomarkers that predict how young children with Autism Spectrum Disorder (ASD) respond to Pivotal Response Treatment (PRT), an evidence-based behavioral intervention. Children aged 2 to 4 years with language delays will be randomized to receive either the PRT program or be placed in a delayed treatment group. The study will utilize neuroimaging techniques to assess brain activity and structure, seeking to correlate these findings with treatment outcomes. The goal is to enhance personalized treatment approaches for children with ASD by understanding biological predictors of response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of Autism Spectrum Spectrum Disorder (ASD) based on clinical interview and Diagnostic and Statistical Manual, 5th edition (DSM-5) and confirmed using the Autism Diagnostic Interview Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS) and/or Brief Observation of Symptoms of Autism (BOSA) and/or Childhood Autism Rating Scale- Second Edition (CARS-2).
* Outpatients between 2.0 and 4.11 years of age of either gender,
* Children of all cognitive levels will be included as long as they are able to participate in the testing procedures to the extent that valid standard scores can be obtained
* Language delay as measured by the Preschool Language Scale, 5th Edition (PLS-5) \[at least 1 standard deviation behind for children age 2 and 3 years; and 2 standard deviations behind for children age 4\],
* Stable psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation,
* Stable treatment \[Applied Behavior Analysis (ABA), Floortime, or other interventions\], speech therapy, and school placement for at least 1 month prior to baseline measurements with no expected changes during study participation,
* No more than 60 minutes of 1:1 speech therapy per week,
* The child's exposure to the English language must be sufficient that administration of standardized tests in English is appropriate for measuring progress,
* The availability of at least one parent who can consistently participate in the training sessions and related activities, and
* Successful completion of baseline brain scan.

Exclusion Criteria:

* Current or life-time diagnosis of severe psychiatric disorder (e.g., bipolar disorder),
* Genetic abnormality (e.g., Fragile X)
* Presence of active medical problem (e.g., unstable seizure disorder),
* Receiving more than 15 hours of in home 1:1 Applied Behavior Analysis (ABA) per week
* Magnetic Resonance (MR) contraindication (e.g., the presence of ferrous metal), or
* Previous adequate Pivotal Response Treatment (PRT) trial.

Where it's running

• Stanford University
  Stanford, California, United States Recruiting

Study contacts

• Principal investigator: Antonio Hardan, MD — Stanford University
• Study coordinator: Estefania Millan, MA
• Email: mmillan2@stanford.edu
• Phone: (650) 736-1235

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.