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

Plain Language Summary

Simplified for easier understanding

Oxytocin — sometimes called the "bonding hormone" — plays an important role in social connection, and researchers have been exploring whether giving oxytocin as a nasal spray might help children with autism spectrum disorder (ASD) become more socially responsive. This study combines oxytocin nasal spray with an established early learning therapy called the Parent-Delivered Early Start Denver Model (P-ESDM), where parents are coached to use specific strategies in everyday play to promote social skills. Children aged 3–5 years will receive either oxytocin or a placebo nasal spray twice daily for 12 weeks, alongside 16 sessions of the P-ESDM therapy. Neither families nor researchers will know which children receive the real drug. The study will measure social responsiveness, communication, and brain-based biomarkers before and after treatment. Your child may be eligible if they are aged 3–5, have a confirmed ASD diagnosis according to DSM-5 criteria including ADOS-2 assessment, and you as a caregiver can commit to attending coaching sessions and practising the therapy strategies at home for 15–20 hours per week. Children with severe nasal obstruction, a known genetic disorder (such as Fragile X), untreated epilepsy, or severe developmental delay are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.