Intranasal Oxytocin in Preschoolers with Autism receiving Social Learning Therapy: A Randomised, Double-blind, Repeated Dose Study Analysing Caregiver-rated Social Responsiveness as a Primary Outcome.

niversity of Sydney0 个研究点目标入组 132 人开始时间: 2018年6月19日最近更新: 2019年2月4日

适应症

试验速览

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•Children who:
•Are aged 3 to 5 years old
•Meet the criteria for Autism Spectrum Disorder (ASD) according to the Diagnostic and Statistical Manual for Mental Disorders – Fifth Edition (DSM-5). The diagnostic term incorporates the previously separate diagnoses of Autistic Disorder, Asperger’s Disorder, and Pervasive Developmental Disorder – Not Otherwise Specified or PDD-NOS)
•Meet the ADOS-2 classification of autism spectrum (administered at, or within 6 months of the Screening Visit)
•Caregivers who:
•Provide written informed consent
•Are committed to attending the parent/caregiver coaching session throughout the study period in order to utilize the strategies taught to them for 15 – 20 hours a week, with their child at home
•Agree not to start a new intensive behavioural treatment during the course of the study.

•Children who:
•Severe nasal obstruction
•Severe hepatic, renal or cardiac dysfunction
•Known genetic disorder (e.g. Fragile X) or neurological syndromes
•Severe co-morbid developmental delay (DQ<35)
•Significant vision, hearing or motor impairment that would interfere with ability to respond to P-ESDM or complete assessments
•Stabilised on psychoactive medications for more than 8 weeks prior to enrolment
•Untreated epilepsy or any non-febrile seizure within 6 months prior to enrolment
•Caregivers who:
•Are not fluent in English

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