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Cited by 346Neuroendocrine regulation and behaviorAutism Spectrum Disorder ResearchGenetics and Neurodevelopmental Disorders

The DOI matches its Crossref record; 39 of the 43 references it cites were found in a registry or an index.

The effect of oxytocin nasal spray on social interaction deficits observed in young children with autism: a randomized clinical crossover trial

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Yatawara, C J, Einfeld, S L, Hickie, I B, Davenport, T A, Guastella, A J·2016·Molecular Psychiatry
DOI 10.1038/mp.2015.162PMC PMC4995545
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Abstract

Interventions for autism are limited. The synthetic hormone oxytocin may provide a potential treatment to improve core social and behavioral difficulties in autism, but its efficacy has yet to be evaluated in young children who potentially may benefit to a greater extent. We investigated the efficacy, tolerability and safety of oxytocin treatment in young children with autism using a double-blind, randomized, placebo-controlled, crossover, clinical trial. Thirty-one children with autism received 12 International Units (IU) of oxytocin and placebo nasal spray morning and night (24 IU per day) for 5 weeks, with a 4-week washout period between each treatment. Compared with placebo, oxytocin led to significant improvements on the primary outcome of caregiver-rated social responsiveness. Overall, nasal spray was well tolerated, and the most common reported adverse events were thirst, urination and constipation. This study is the first clinical trial to support the potential of oxytocin as an early intervention for young children with autism to help improve social interaction deficits.

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Crossref · 10.1038/mp.2015.162

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Figure 1 Consort diagram of study participants by randomization schedule. Parents of 64 children initially contacted the Brain and Mind Centre (BMC) to enquire about the study, of which 44 children were screened for eligibility. Thirty-nine children entered the randomization schedule, and 32 (82%) completed phase 1 and then crossed-over to phase 2. One participant was excluded before completion of phase 2 because of time commitments in following the protocol. The final number of participants included in the analyses was 31, including 15 randomized to ‘oxytocin then placebo' and 16 to ‘placebo then oxytocin'.
Figure 1 Consort diagram of study participants by randomization schedule. Parents of 64 children initially contacted the Brain and Mind Centre (BMC) to enquire about the study, of which 44 children were screened for eligibility. Thirty-nine children entered the randomization schedule, and 32 (82%) completed phase 1 and then crossed-over to phase 2. One participant was excluded before completion of phase 2 because of time commitments in following the protocol. The final number of participants included in the analyses was 31, including 15 randomized to ‘oxytocin then placebo' and 16 to ‘placebo then oxytocin'.CC BY-NC-ND · PubMed Central
Figure 2 Plotting mean scores on the primary (caregiver-rated Social Responsiveness Scale (SRS-P), caregiver-rated Repetitive Behavior Scale-Revised (RBS-R-P)) and secondary (caregiver-rated Developmental Behavior Checklist (DBC-P)) outcome measures by time and condition, N=31.
Figure 2 Plotting mean scores on the primary (caregiver-rated Social Responsiveness Scale (SRS-P), caregiver-rated Repetitive Behavior Scale-Revised (RBS-R-P)) and secondary (caregiver-rated Developmental Behavior Checklist (DBC-P)) outcome measures by time and condition, N=31.CC BY-NC-ND · PubMed Central
Figure 3 Caregiver-rated Social Responsiveness Scale (SRS-P) pre- and post-test scores after oxytocin (red triangles) and placebo (black triangles), N=31. The solid diagonal line represents ‘line of no change' and the dotted lines upper and lower Reliable Change Index (RCI) confidence limits. Test-retest reliability=0.84; s.d. for the pretest=22.6.
Figure 3 Caregiver-rated Social Responsiveness Scale (SRS-P) pre- and post-test scores after oxytocin (red triangles) and placebo (black triangles), N=31. The solid diagonal line represents ‘line of no change' and the dotted lines upper and lower Reliable Change Index (RCI) confidence limits. Test-retest reliability=0.84; s.d. for the pretest=22.6.CC BY-NC-ND · PubMed Central

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Research works printed but not linked: 2

  1. Einfeld SL, Tonge BT . Manual for the Developmental Behaviour Checklist (Second Edition)-Primary Carer Version (DBC-P-P) and Teacher Version (DBC-P-T). Monash University Centre for Developmental Psychiatry and Psychology and School of Psychiatry, University of New South Wales: : Melbourne and Sydney, Australia, 2002.
  2. Roid GH, Miller LJ . Leiter International Performance Scare-Revised. Stoeling: : Wooddale, IL, USA, 1997.

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Metadata

Authors
Yatawara, C. J., Einfeld, S. L., Hickie, I. B., Davenport, T. A., & Guastella, A. J.
Affiliations
The University of Sydney (AU)
Corresponding author
Guastella, A J
ORCID
Venue
Molecular Psychiatry
Publisher
Springer Science and Business Media LLC
Published
2015-10-27
Volume
21
Issue
9
Pages
1225-1231
ISSN
  • 1359-4184 (ISSN-L)
  • 1476-5578
DOI
10.1038/mp.2015.162
PMC
PMC4995545
OpenAlex
W1823169087
Cited by
344
References
43
Citations by year
2026: 18 · 2025: 18 · 2024: 27 · 2023: 21 · 2022: 38 · 2021: 26 · 2020: 34 · 2019: 36 · 2018: 41 · 2017: 44 · 2016: 37 · 2015: 4
FWCI
68.73
Type
journal article
Language
en
Open access
Licence
Locations
  • Molecular Psychiatry (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
Funders
National Health and Medical Research Council (APP 511921, 511921, 623625, 1043664, 1061922)
Topics
  • Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Neuroendocrine regulation and behavior
  • Life Sciences › Neuroscience › Cognitive Neuroscience › Autism Spectrum Disorder Research
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Genetics and Neurodevelopmental Disorders
Keywords
oxytocin, autism spectrum disorder, young children, nasal spray, social interaction deficits, social responsiveness, early intervention, treatment tolerability, adverse events
MeSH terms
Autism Spectrum Disorder, Administration, Intranasal, Autistic Disorder, Child, Child, Preschool, Double-Blind Method, Female, Humans, Interpersonal Relations, Male, Oxytocin, Social Behavior, Treatment Outcome, Cross-Over Studies, Nasal Sprays

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