Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism
Trial Parameters
Brief Summary
The primary objective of this study is to evaluate the cognitive and behavioral effects of liquid leucovorin calcium on young children with autism spectrum disorder (ASD) and determine whether it improves social communication as well as the core and associated symptoms of ASD. The investigators will enroll 80 children across two sites, between the ages of 2.5 and 5 years, with confirmed ASD and known social and communication delays. Participation will last approximately 26 weeks, from screening visit to end of treatment.
Eligibility Criteria
Inclusion Criteria: 1. 1\. Autism Spectrum Disorder (diagnosed as Autistic Disorder on the ADOS-2 or the ADI-R). 2. Between 2 years 6 months and 5 years 2 months of age at baseline 3. Folate Receptor Alpha Autoantibody Positive status 4. Language impairment (Ages and Stage Questionnaire between -1 and -3 SD for Language) 5. English included in the languages in which the child is being raised 6. Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale. Moderate level of autism severity (4) is defined by the diagnosis of ASD with language impairment, so fulfilling #1 and #4 fulfills this requirement. 7. Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period 8. Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry 9. Has at least 4 month old expressive language ability as assessed by the MSEL Expressive Language Scale (i.