Autism Spectrum Disorder
Conditions
Interventions
Placebo:oromucosal administration of placebo freeze dried on the surface of a sugar-free lollipop every other day for 12 weeks followed after 30 min by a 30 min positive social interaction with an adu
Oxytocin low dose (12IU):oromucosal administration of 12IU oxytocin acetate freeze dried on the surface of a sugar-free lollipop every other day for 12 weeks followed after 30 min by a 30 min positive
Oxytocin medium dose (24IU):oromucosal administration of 24IU oxytocin acetate freeze dried on the surface of a sugar-free lollipop every other day for 12 weeks followed after 30 min by a 30 min posit
Oxytocin high dose (48IU):oromucosal administration of 48IU oxytocin acetate freeze dried on the surface of a sugar-free lollipop every other day for 12 weeks followed after 30 min by a 30 min positiv
Sponsors
University of Electronic Science and Technology of China
Eligibility
Sex/Gender
All
Age
2 Years to 6 Years
Inclusion criteria
Inclusion criteria: Children (male or female) aged between 2 and 6 years diagnosed with autism spectrum disorder by DSM-V and scoring 5 or higher on the ADOS-2 comparison score.
Exclusion criteria
Exclusion criteria: Any children receiving psychotropic medications during the course of the trial or with any identified genetic or chromosomal abnormalities (Fragile X or Rett syndromes) or diagnosed with a neurological disease (e.g., epilepsy, cerebral palsy), or psychiatric disorder other than autism spectrum disorder or severe respiratory, hearing,or visual impairments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Autism Diagnostic Observation Schedule - 2 (ADOS-2) score;Social Responsivity Scale-2 (SRS-2) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Griffiths Mental Development Scale-Chinese (GDS-C) score;Childhood Autism Rating Scale (CARS) score;Repetitive Behavior Scale-Revised (RBS-R) score;Adaptive Behavior Assessment Schedule – 2 (ABAS-2) score;Psychoeducational Profile 3rd edition (PEP-3) score;Caregiver strain questionnaire (CSQ) score;Brain structural magnetic resonance imaging;Brain resting state functional magnetic imaging;Genotype data;Oxytocin concentration in blood;Oxytocin concentration in saliva;Cytokine concentrations in blood;Eye tracking measures of social attention; | — |
Countries
China
Contacts
Public ContactKeith Kendrick
University of Electronic Science and Technology of China
Outcome results
None listed