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Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
Recruiting
I'm InterestedTrial ID: NCT03583684
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
Stanford Investigator(s)
Antonio Hardan, M.D.
Professor of Psychiatry and Behavioral Sciences
Eligibility
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.
Intervention(s):
behavioral: Pivotal Response Treatment Program (PRT-P)
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Estefania Millan, MA
650-736-1235