Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
Trial ID or NCT#
Status
RECRUITING
Purpose
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
Eligibility 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.
- * 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.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Estefania Millan, MA
650-736-1235
View on ClinicalTrials.gov
