Oxytocin in Preschoolers with Autism receiving Social Learning Therapy

Phase 2

Recruiting

• Conditions: Autism Spectrum Disorders; Mental Health - Autistic spectrum disorders

• Registration Number: ACTRN12618001029280
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-19
• Last Update Posted: 4 February 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in parent rated Social Deficit Scores as assessed by the Pervasive Developmental Disorder Behaviour Inventory - Screening Version (PDDBI-SV).[The PDDBI-SV will be administered pre-treatment at Visit 1 (Study week 1), post-treatment at Visit 3 (study week 12 - primary endpoint) and at 3-month follow-up (Post-treatment, study week 26). ]