Actively Recruiting
Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
Led by Stanford University · Updated on 2025-11-10
36
Participants Needed
1
Research Sites
416 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
N
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Autism Spectrum Disorder based on clinical interview and DSM-5, confirmed by ADI-R and ADOS and/or BOSA and/or CARS-2
- Outpatients aged between 2.0 and 4.11 years, any gender
- Children of all cognitive levels able to participate in testing to obtain valid standard scores
- Language delay shown by Preschool Language Scale-5: at least 1 standard deviation behind for ages 2 and 3, and 2 standard deviations behind for age 4
- Stable psychotropic medications or biomedical interventions for at least 1 month before baseline with no expected changes
- Stable treatments such as ABA, Floortime, speech therapy, or school placement for at least 1 month before baseline with no expected changes
- Receiving no more than 60 minutes of one-on-one speech therapy per week
- Sufficient exposure to English for standardized testing
- At least one parent available to consistently participate in training and related activities
- Successful completion of baseline brain scan
You will not qualify if you...
- Current or lifetime diagnosis of severe psychiatric disorder like bipolar disorder
- Genetic abnormalities such as Fragile X syndrome
- Presence of active medical problems like unstable seizure disorder
- Receiving more than 15 hours per week of in-home one-on-one ABA therapy
- Contraindication for MRI such as presence of ferrous metal
- Previous adequate trial of Pivotal Response Treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94305-5719
Actively Recruiting
Research Team
E
Estefania Millan, MA
CONTACT
J
John Hegarty, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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