Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism
Southwest Autism Research & Resource Center
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.
Description
Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental disorder with life-long consequences that affects young children during critical times in their development. ASD is defined by impairments in social-communication as well as the presence of restricted interests and repetitive behaviors. ASD is frequently associated with co-occurring language delays. Currently the only well-accepted treatment for core ASD symptoms is behavior therapy such as Applied Behavioral Analysis and Early Intensive Behavioral Intervention. There is no US Food and Drug Administration approved medical the…
Eligibility
- Age range
- 2–5 years
- Sex
- All
- Healthy volunteers
- No
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,…
Interventions
- DrugLevoleucovorin Calcium
Liquid leucovorin calcium dosed by weight
- OtherPlacebo
Placebo
Locations (2)
- Southwestern Research & Resource CenterPhoenix, Arizona
- State University of New York, DownstateBrooklyn, New York