RecruitingPhase 2ACTRN12618001029280

Oxytocin in Preschoolers with Autism receiving Social Learning Therapy

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.

Sponsor

University of Sydney

Enrollment

132 participants

Start Date

Dec 6, 2018

Study Type

Interventional

Conditions

Autism Spectrum Disorders

Summary

Children with ASD aged 3 - 5 years old will receive a twice-daily nasally-administered oxytocin or placebo nasal spray for a period of 12-weeks and will also concurrently receive 16 sessions of the Parent-Delivered Early Start Denver Model early learning intervention. Assignment to either the placebo or oxytocin group will be randomised with researchers and participants unaware of treatment group allocation (blinded). Using this double-blinded placebo-controlled between subjects design we hope to identify children with ASD who may benefit from this treatment and the associated cognitive/neurobiological markers that predict these benefits. It is hypothesised that at post-treatment and at three-month follow up, OT treatment combined with P-ESDM will: 1. Improve caregiver-rated social responsiveness as measured by the Pervasive Developmental Disorder Behavior Inventory – Screening Version (PDDBI-SV)

Eligibility

Sex: Both males and femalesMin Age: 3 YearssMax Age: 65 Yearss

Inclusion Criteria8

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 Criteria10

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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Interventions

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

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.