Joint Clinical Trials Office

You are here

Brain and Behavioral Changes Over Time in Young Children with Autism

Clinical Trial Details

This study has the goal of furthering our understanding of the longitudinal course of autism spectrum disorder (ASD). Specifically, we propose a longitudinal study of young children with ASD (2-3 years) to identify the neurobiological underpinnings of early developmental changes in restricted repetitive behavior/interests (RRB), one of the most clinically impairing aspects of ASD - and their predictive contribution to later function. 

Key Eligibility: 

Inclusion Criteria: 

  • 20-34 months of age at the first visit 
  • Child must be walking independently 
  • Parent/legal guardian must be fluent in English 
  • Family must have concerns about autism or social development 

Exclusion Criteria: 

  • Medical illness requiring chronic treatment 
  • Intrathecal chemotherapy or focal cranial irradiation 
  • History of leukomalacia or static encephalopathy intracerebral hemorrhage grade 2 
  • Other specific or focal neurological or metabolic disorder including epilepsy, traumatic brain injury 
  • Severe hearing and/or visual impairment 
  • Cerebral palsy; Diagnosis or physical signs strongly suggestive of a genetic condition or syndrome known to be associated with ASD (e.g., fragile X syndrome, Tuberous Sclerosis, and Rett’s Syndrome). Recent technological advances have increasingly identified non syndromic de novo mutations associated with ASD. If reported by the family, these genetic mutations will not be exclusionary 
  • Premature birth (<36 weeks estimated gestational age or birth weight <2000g) 
  • Any contraindication for MRI scanning 
  • Currently taking any psychotropic medications at T1 
  • Current significant history of severe insomnia 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Claire Klein
914-269-8702
toddlerstudy@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1904020114

Sponsor:

NIMH 5R01MH115363-02

Status

Open to Enrollment

Age Group

Pediatric

Sponsor