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Brain Scans and Response to Pivotal Response Treatment in Young Children With Autism

Tests a behavioral language program, Pivotal Response Treatment, in young children with autism.

Plain-language title generated from the registry record
Registry title: Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism

Key facts

Where
Stanford, United StatesSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 4 years old?

Source: NCT03583684, who can take part

Where in United States

  • Stanford UniversityStanford, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Stanford University
Trial code
NCT03583684
Record updated
5 November 2026
Original description
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).Read full original descriptionShow less

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

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).

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

ClinicalTrials.gov NCT03583684