Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000784213
Ethics application status
Approved
Date submitted
1/09/2009
Date registered
9/09/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Oxytocin and social interactions in young people with autism spectrum disorders.
Scientific title
The impact of oxytocin on social cognition and behaviour in youth with autism spectrum disorders.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism spectrum disorders. 243612 0
Condition category
Condition code
Mental Health 239907 239907 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Emotion recognition training (ERT) plus 4 doses of nasal spray oxytocin. The ERT program for children is designed to be used together with the Mindreading (MR) program which was developed by Simon Baron-Cohen from Cambridge University. The program, delivered by a trained therapist, aims to train children about emotions. The ERT program will be delivered over four consecutive days. Each session will require approximately 90mins and involves workbook activities, computer tasks and role play. The participants will receive 1 dose of Oxytocin prior to commencing ERT (one dose per day).
Intervention code [1] 241199 0
Treatment: Other
Intervention code [2] 241232 0
Behaviour
Comparator / control treatment
Active emotion recognition training plus placebo. The emotion recognition training (ERT) is exactly the same as administered to the treatment group. The placebo with be administered, via a nasal spray, on 4 occasions, once daily prior to the ERT. The placebo contains Glycerine, Methyl Parraben, Propyl Paraben and Purified Water.
Control group
Placebo

Outcomes
Primary outcome [1] 240692 0
Eye gaze to human eyes of computer faces, and participant's primary caregiver. We will be measuring the duration of time spend looking at the eyes of faces on computer screen during an emotion recognition task. This will be measured using eye tracking equipment. We will also measure the amount of time the participant spends looking at the eyes of his primary caregiver during a family observation task. Thsi will be measured through a coding system.
Timepoint [1] 240692 0
Four; pre, 2 x during, and post. The first time point refers to data gathered 3 months prior to treatment commencing. Data will then be gathered the day prior to treatment and each day of treatment. The final time point will be 3 months following treatment.
Secondary outcome [1] 257331 0
The secondary outcome is positive social interaction with primary caregiver. This will be measured via a coding system during the family observation tasks and also through parent/guardian questionnaires
Timepoint [1] 257331 0
Four; pre, 2 x during, and post. The first time point refers to data gathered 3 months prior to treatment commencing. Data will then be gathered the day prior to treatment and each day of treatment. The final time point will be 3 months following treatment.

Eligibility
Key inclusion criteria
Autsim spectrum disorder.
Minimum age
8 Years
Maximum age
16 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Major comorbid illness; Intelligence Quotient (IQ) < 80 measure with the Wechsler Intelligence Scale for Children – Fourth Edition (WISC-IV); use of regular psychoactive medication;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237557 0
Government body
Name [1] 237557 0
National Health and Medical Research Council (NHMRC)
Country [1] 237557 0
Australia
Primary sponsor type
University
Name
University of New South Wales (UNSW)
Address
University of New South Wales Kensington Campus, Kensington, Syndey, NSW, 2052
Country
Australia
Secondary sponsor category [1] 237033 0
None
Name [1] 237033 0
Address [1] 237033 0
Country [1] 237033 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243690 0
University of New South Wales Human Research Ethics Committee (HREC)
Ethics committee address [1] 243690 0
Ethics committee country [1] 243690 0
Australia
Date submitted for ethics approval [1] 243690 0
Approval date [1] 243690 0
Ethics approval number [1] 243690 0

Summary
Brief summary
The aim of this proposed
research is to test precisely whether Oxytocin (OT) potentiates learning of emotion recognition training, improving
processing of emotion information, thus leading to an increase in the quality and quantity of participants' social
interactions with a parent or guardian.

Participants will be randomly allocated to one of two groups, (1) combined Oxytocin (OT) and emotion recognition training (ERT),(2) combined placebo and Emotion Recognition Training. Effects will be examined at three levels; 1) immediate, 2) intermediate and 3) distal. Immediate effects refer to the direct impact of combined Oxytocin and Emotion Recognition Training on the basic components of social interaction. The intermediate effects of interest refer to the social interactions recorded by parents/guardians in the extended period (24 hours) following combined Oxytocin administration and Emotion Recognition Training. Distal effects will also be determined to gauge the potential for cumulative effects of combined Oxytocin and Emotion Recognition Training over a number of consecutive administrations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30101 0
Address 30101 0
Country 30101 0
Phone 30101 0
Fax 30101 0
Email 30101 0
Contact person for public queries
Name 13348 0
Elayne MacDonald
Address 13348 0
School of Psychology
The University of New South Wales
NSW 2052
Country 13348 0
Australia
Phone 13348 0
+61 2 9385 1697
Fax 13348 0
+61 2 9385 3641
Email 13348 0
[email protected]
Contact person for scientific queries
Name 4276 0
Mark Dadds
Address 4276 0
School of Psychology
The University of New South Wales
NSW 2052
Country 4276 0
Australia
Phone 4276 0
+61 2 9385 3538
Fax 4276 0
+61 2 9385 3641
Email 4276 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.