ACTRN12618001029280
Recruiting
Phase 2
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.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Autism Spectrum Disorders
- Sponsor
- niversity of Sydney
- Enrollment
- 132
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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