Study design
RECRUITMENT, BRAIN
Patients were enrolled in a double-blind, randomized controlled, placebo lead-in, multi-site trial of oxytocin nasal spray and an identical placebo across four assessment time points (wk 0 baseline, wk 3 post-placebo lead in, wk 15 post randomized treatment, wk 27 follow-up assessment). The study was conducted at the Brain & Mind Center (BMC), University of Sydney, and the Telethon Kids Institute (TKI), Western Australia. Ethical approval was provided by the University of Sydney Human Research Ethics Committee (2013/502). The trial was pre-registered prior to recruitment with the Australian Clinical Trials Registry (ACTRN12617000441314). Informed consent from caregivers was obtained for each participant.