Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Psychiatric, Autism, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 2 - 4 |
| Updated: | 2/17/2019 |
| Start Date: | December 7, 2018 |
| End Date: | November 30, 2020 |
| Contact: | Jaelyn Edwards, BS |
| Email: | jedwrds@stanford.edu |
| Phone: | (650) 736-1235 |
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).
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 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),
- 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.
We found this trial at
1
site
450 Serra Mall
Stanford, California 94305
Stanford, California 94305
(650) 723-2300
Principal Investigator: Antonio Y. Hardan, MD
Phone: 650-736-1235
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
Click here to add this to my saved trials
