NCT03583684 Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
| NCT ID | NCT03583684 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2018-12-07 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2018-12-07 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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.
Contact & Investigator
Antonio Hardan, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT03583684 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 4 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03583684 currently recruiting?
Yes, NCT03583684 is actively recruiting participants. Contact the research team at mmillan2@stanford.edu for enrollment information.
Where is the NCT03583684 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT03583684 clinical trial?
NCT03583684 is sponsored by Stanford University. The principal investigator is Antonio Hardan, MD at Stanford University. The trial plans to enroll 36 participants.