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Treatment Study for Children with Autism Spectrum Disorder

  • Study HIC#:2000021581
  • Last Updated:07/15/2021

The present study examines the impact of Pivotal Response Treatment (PRT) and oxytocin on the development of language, social, and play skills in young children with Autism Spectrum Disorder (ASD). PRT is a well-validated, naturalistic and play-based treatment for children with ASD. All children who participate in this study will receive PRT three times a week at the Yale Child Study Center for 16 weeks. The purpose of this study is to examine the impact of oxytocin as an enhancer of response to PRT. Participants will be randomly assigned to either an oxytocin nasal spray group or a placebo nasal spray group. Neither the research team nor the participants will know or choose which group the participant is assigned to.

  • Age5 years - 9 years
  • GenderBoth
  • Start Date10/31/2018
  • End Date08/30/2020

Eligibility Criteria

Inclusion Criteria:

  1. Fit the age requirement: age 5-8
  2. Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team
  3. Be in good medical health
  4. Be cooperative with testing
  5. Speak English in the family
  6. Successfully complete an fMRI scan
  7. Full-scale intelligence quotient (IQ)>70

Exclusion Criteria:

  1. Any metal or electromagnetic implants, including:
    1. Cardiac pacemaker
    2. Defibrillator
    3. Artificial heart valve
    4. Aneurysm clip
    5. Cochlear implants
    6. Shrapnel
    7. Neurostimulators
    8. History of metal fragments in eyes or skin
  2. Significant hearing loss or other severe sensory impairment
  3. A fragile health status.
  4. Current use of prescription psychotropic medications that may affect cognitive processes under study.
  5. A history of significant head trauma or serious brain or psychiatric illness

Sub-Investigators

For more information about this study, contact the Help us Discover team on: