Introduction
lifelong social behavior, impairments in social communication, Autism spectrum disorder, repetitive behaviors, autism
RECRUITMENT
Autism spectrum disorder (autism) is a neurodevelopmental condition characterized in the DSM-V by impairments in social communication and interaction, and the presence of stereotypical and repetitive behaviors [Oxytocin is a crucial regulatory hormone to both early life social learning and lifelong social behavior [This present study investigated the efficacy, tolerability, and safety of intranasally-administered oxytocin to improve social interaction difficulties in young autistic children. This study included a placebo lead-in phase to evaluate response to drug to characterize potential responders and focused recruitment at a younger age than most clinical trials. We predicted that oxytocin nasal spray would be both safe and tolerable for this cohort of young autistic children. We further predicted that oxytocin would improve caregiver-reported social responsiveness, and a clinician rating of improvement in social behavior in young children with autism, and that this effect would be largest in younger children.