Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism


I'm Interested

Trial ID: NCT03583684


Autism spectrum disorder (ASD) is a very heterogeneous disorder with limited empirically validated behavioral and biological interventions. The goal of this pilot investigation is to apply a biologically-based approach to identify predictors of treatment response in children with ASD who are receiving Pivotal Response Treatment (PRT), an evidence-based behavioral intervention. Specifically, the investigators propose to identify neuroimaging biomarkers of treatment response to a PRT program (PRT-P) targeting language deficits in young children with ASD who will be randomized to either PRT-P or to a delayed treatment group (DTG).

Official Title

Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism

Stanford Investigator(s)

Antonio Hardan, M.D.
Antonio Hardan, M.D.

Professor of Psychiatry and Behavioral Sciences


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

   - 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

   - 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.


behavioral: Pivotal Response Treatment Program (PRT-P)


I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Estefania Millan, MA