Identifying brain markers for treatment response in young children with autism
Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
NA · Stanford University · NCT03583684
This study is testing if brain scans can help predict how young children with autism will respond to a specific therapy to improve their behavior and communication skills.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 2 Years to 4 Years |
| Sex | All |
| Sponsor | Stanford University (other) |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT03583684 on ClinicalTrials.gov |
What this trial studies
This pilot investigation aims to identify neuroimaging biomarkers that predict how young children with Autism Spectrum Disorder (ASD) respond to Pivotal Response Treatment (PRT), an evidence-based behavioral intervention. Children aged 2 to 4 years with language delays will be randomized to receive either the PRT program or be placed in a delayed treatment group. The study will utilize neuroimaging techniques to assess brain activity and structure, seeking to correlate these findings with treatment outcomes. The goal is to enhance personalized treatment approaches for children with ASD by understanding biological predictors of response.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 4 years diagnosed with Autism Spectrum Disorder who exhibit language delays.
Not a fit: Patients who do not have a diagnosis of Autism Spectrum Disorder or who are not experiencing language delays may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, tailored interventions for young children with autism, improving their language development.
How similar studies have performed: While there have been studies exploring neuroimaging in autism, this specific approach of linking neuroimaging biomarkers to treatment response in PRT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Stanford, California
- Stanford University — Stanford, California, United States (RECRUITING)
Study contacts
- Principal investigator: Antonio Hardan, MD — Stanford University
- Study coordinator: Estefania Millan, MA
- Email: mmillan2@stanford.edu
- Phone: (650) 736-1235
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autism Spectrum Disorder, Autism, Pivotal Response Treatment, Imaging