RECRUITING

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

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Conditions

Autism Spectrum DisorderAutismPivotal Response TreatmentImaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2018-12-07
Study Completion:2026-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03583684

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 4 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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).
  2. * Outpatients between 2.0 and 4.11 years of age of either gender,
  3. * 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
  4. * Language delay as measured by the Preschool Language Scale, 5th Edition (PLS-5) \[at least 1 standard deviation behind for children age 2 and 3 years; and 2 standard deviations behind for children age 4\],
  5. * Stable psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation,
  6. * 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,
  7. * No more than 60 minutes of 1:1 speech therapy per week,
  8. * The child's exposure to the English language must be sufficient that administration of standardized tests in English is appropriate for measuring progress,
  9. * The availability of at least one parent who can consistently participate in the training sessions and related activities, and
  10. * Successful completion of baseline brain scan.
  1. * Current or life-time diagnosis of severe psychiatric disorder (e.g., bipolar disorder),
  2. * Genetic abnormality (e.g., Fragile X)
  3. * Presence of active medical problem (e.g., unstable seizure disorder),
  4. * Receiving more than 15 hours of in home 1:1 Applied Behavior Analysis (ABA) per week
  5. * Magnetic Resonance (MR) contraindication (e.g., the presence of ferrous metal), or
  6. * Previous adequate Pivotal Response Treatment (PRT) trial.

Contacts and Locations

Study Contact

Estefania Millan, MA
CONTACT
(650) 736-1235
mmillan2@stanford.edu
John Hegarty, PhD
CONTACT
(650) 736-1235
hegartyj@stanford.edu

Principal Investigator

Antonio Hardan, MD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Stanford University
Stanford, California, 94305-5719
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Antonio Hardan, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-12-07
Study Completion Date2026-11-30

Study Record Updates

Study Start Date2018-12-07
Study Completion Date2026-11-30

Terms related to this study

Keywords Provided by Researchers

  • Pivotal Response Treatment
  • Imaging

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Autism