Oxytocin in Preschoolers with Autism receiving Social Learning Therapy

Participants will be randomly allocated to receive either active oxytocin or placebo nasal spray twice daily over a period of 12 weeks. Participants randomly allocated to receive active oxytocin will administer 16 IU of nasal spay twice a day (1 x 8 IU spray per nostril), receiving a total of 32IU per day of oxytocin. Caregivers will assist participants in administering the nasal spray. Caregivers will be requested to complete a Compliance/Side Effects Monitoring Form to verify that the nasal spray was administered each morning and evening. This form will be given to parents at Study Visit 1 (prior to the nasal spray administration) and will be returned for site review at Study Visit 2 (Mid-treatment Assessment visit) and Study Visit 3 (Post-treatment Assessment Visit). Compliance will also be assessed by the trial coordinator through discussion with parents at Study Visits 1 and 2. Finally, parents will be requested to return the nasal spray bottles at each study visit so that compliance can be monitored via weighing each bottle at Study Visits 2 and 3. All participants will receive a Social Learning Therapy known as the Parent-delivered Early Start Denver Model (P-ESDM) over the course of the 12-week Placebo/Oxytocin treatment period. The P-ESDM involves 16 parent/caregiver training session delivered by a certified P-ESDM therapist. Parents will receive 2 parent/caregiver training sessions which will be delivered onsite each week for a period of 4 weeks. Parents/caregivers will then receive 1 training session per week for the remaining 8 weeks. Each session will last 1 hour in duration. Each P-ESDM session will focus on improving caregiver intervention skills through the use of fun and interactive social games. Parents will be trained on the delivery of P-ESDM techniques by an P-ESDM certified coach. The content of each session will focus on learning activities and techniques that will: increase the child's attention and motivation, improve the use of sensory social routines, promote dyadic engagement and joint activity routines; enhance nonverbal communication, build imitation skills; facilitate joint attention; promote speech development; increase the use of antecedent-behaviour-consequence relationships. P-ESDM compliance will be assessed through the use of a Fidelity tool. Here, parents will have the first 10-minutes of their onsite P-ESDM session recorded. Trained assessors will then use this video to code parent behaviours and compliance to P-ESDM principles before completing a fidelity tool. Parents will also be asked to keep a daily log of the number of hours spent with their child during which they utilised the P-ESDM strategies. This will be reviewed by study staff at each study visit.