Effects of Oxytocin on Social Behavior and Repetitive Behavior in Children with Autism.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12611000061932
• Date of registration: 17/01/2011
• Prospective Registration: No
• Primary sponsor: University of Sydney
• Public title: Effects of Oxytocin on Social Behavior and Repetitive Behavior in Children with Autism.
• Scientific title: A Course of Oxytocin To Improve Social Interaction and Repetitive Behaviors In Children With Autism Spectrum Disorders.
• Date of first enrolment: 02/12/2010
• Target sample size: 40
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12611000061932.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Efficacy;
• Phase: Phase 2

Countries of recruitment

Australia

Contacts

• Name: Miss Chathuri (CJ) Yatawara

• Name: A/Prof Adam Guastella

Key inclusion & exclusion criteria

Inclusion criteria: Meet DSM-IV-TR criteria for ASD
Exclusion criteria: Not sensitive to preservatives (in particular E 216, E 218, and chlorobutanol hemihydrate)

Age minimum: 3 Years
Age maximum: 8 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Autism Spectrum Disorders.;
Autism Spectrum Disorders.

Mental Health - Autistic spectrum disorders

Intervention(s)

Oxytocin nasal spray.
Duration: 5 week treatment. First week, the dose will start at 3 International Units (IU) and increase by 3IU every 2 days. From the 7th day onwards, participants will receive 12IU for the remaining 4 weeks. The nasal spray will be delivered everyday, morning and night, one spray per nostril
This is a crossover study, so after the first course of treatment, participants will have a 4 week washout period and then commence the alternative treatment. The alternative treatment will follow the same dose escalation procedure as the first course of treatment.

Primary Outcome(s)

Positive social interaction as indexed by observational tasks, parent and teacher questionnaires and a coding protocol to tally the frequency of social behaviors during observational assessments and home therapy sessions.[Four; pre and post for spray 1 and pre and post for spray 2]

Severity of repetitive behavior will be measured using the caregiver/guardian and teacher repetitive behavior scale- revised. in addition, a coding protocol will be used to tally the frequency of specific repetitive behaviors during observational assessments and home therapy sessions.[Four; pre and post for spray 1 and pre and post for spray 2]

Secondary Outcome(s)

Quality of social interactions as indexed by the quality of social behavior scale (therapist and teacher reports)[reports to be filled out each week for 4 weeks prior to each treatment, then each week the participant is on the full dose of nasal spray (4 weeks).]

General improvement as indicated by the clinical Global Impressions score[Four; pre and post for spray 1 and pre and post for spray 2]

Eye gaze to dynamic human faces portrayed on a computer screen. Eye tracking equipment will record the duration and frequency of fixations to facial features during a video scene.[Four; pre and post for spray 1 and pre and post for spray 2]

Level of executive functioning measured with four behavioral tasks.[Four; pre and post for spray 1 and pre and post for spray 2]

Preferential attention to social stimuli will be assessed using a visual exploration task and eye tracking equipment.[Four; pre and post for spray 1 and pre and post for spray 2]

Behavioral and emotional problems as assessed by the Developmental Behavior Checklist (DBC)[Four; pre and post for spray 1 and pre and post for spray 2]

Secondary ID(s)

Nil

Ethics review

Status: Approved
Approval date:
Contact:

University of Sydney Human ethics committee