Effects of multiple-dose intranasal oxytocin administration on social responsiveness in children with autism: a randomized, placebo-controlled trial
Abstract Background Intranasal administration of oxytocin is increasingly explored as a new approach to facilitate social development and reduce disability associated with a diagnosis of autism spectrum disorder (ASD). The efficacy of multiple-dose oxytocin administration in children with ASD is, ho...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-04-01
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| Series: | Molecular Autism |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13229-023-00546-5 |
| _version_ | 1797841044101922816 |
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| author | Nicky Daniels Matthijs Moerkerke Jean Steyaert Annelies Bamps Edward Debbaut Jellina Prinsen Tiffany Tang Stephanie Van der Donck Bart Boets Kaat Alaerts |
| author_facet | Nicky Daniels Matthijs Moerkerke Jean Steyaert Annelies Bamps Edward Debbaut Jellina Prinsen Tiffany Tang Stephanie Van der Donck Bart Boets Kaat Alaerts |
| author_sort | Nicky Daniels |
| collection | DOAJ |
| description | Abstract Background Intranasal administration of oxytocin is increasingly explored as a new approach to facilitate social development and reduce disability associated with a diagnosis of autism spectrum disorder (ASD). The efficacy of multiple-dose oxytocin administration in children with ASD is, however, not well established. Methods A double-blind, randomized, placebo-controlled trial with parallel design explored the effects of a 4-week intranasal oxytocin administration (12 IU, twice daily) on parent-rated social responsiveness (Social Responsiveness Scale: SRS-2) in pre-pubertal school-aged children (aged 8–12 years, 61 boys, 16 girls). Secondary outcomes included a questionnaire-based assessment of repetitive behaviors, anxiety, and attachment. Effects of oxytocin were assessed immediately after the administration period and at a follow-up, 4 weeks after the last administration. The double-blind phase was followed by a 4-week single-blind phase during which all participants received intranasal oxytocin. Results In the double-blind phase, both the oxytocin and placebo group displayed significant pre-to-post-improvements in social responsiveness and secondary questionnaires, but improvements were not specific to the intranasal oxytocin. Notably, in the single-blind phase, participants who were first allocated to intranasal placebo and later changed to intranasal oxytocin displayed a significant improvement in social responsiveness, over and above the placebo-induced improvements noted in the first phase. Participants receiving oxytocin in the first phase also showed a significant further improvement upon receiving a second course of oxytocin, but only at the 4-week follow-up. Further, exploratory moderator analyses indicated that children who received psychosocial trainings (3 or more sessions per month) along with oxytocin administration displayed a more pronounced improvement in social responsiveness. Limitations Future studies using larger cohorts and more explicitly controlled concurrent psychosocial trainings are warranted to further explore the preliminary moderator effects, also including understudied populations within the autism spectrum, such as children with co-occurring intellectual disabilities. Conclusions Four weeks of oxytocin administration did not induce treatment-specific improvements in social responsiveness in school-aged children with ASD. Future studies are warranted to further explore the clinical efficacy of oxytocin administration paired with targeted psychosocial trainings that stimulate socio-communicative behaviors. Trial registration The trial was registered with the European Clinical Trial Registry (EudraCT 2018-000769-35) on June 7th, 2018 ( https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-000769-35/BE ). |
| first_indexed | 2024-04-09T16:24:34Z |
| format | Article |
| id | doaj.art-e8657d0d05f6404c842820a7a40b5f50 |
| institution | Directory Open Access Journal |
| issn | 2040-2392 |
| language | English |
| last_indexed | 2024-04-09T16:24:34Z |
| publishDate | 2023-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Molecular Autism |
| spelling | doaj.art-e8657d0d05f6404c842820a7a40b5f502023-04-23T11:19:20ZengBMCMolecular Autism2040-23922023-04-0114111310.1186/s13229-023-00546-5Effects of multiple-dose intranasal oxytocin administration on social responsiveness in children with autism: a randomized, placebo-controlled trialNicky Daniels0Matthijs Moerkerke1Jean Steyaert2Annelies Bamps3Edward Debbaut4Jellina Prinsen5Tiffany Tang6Stephanie Van der Donck7Bart Boets8Kaat Alaerts9Department of Rehabilitation Sciences, KU LeuvenLeuven Autism Research (LAuRes), KU LeuvenLeuven Autism Research (LAuRes), KU LeuvenLeuven Autism Research (LAuRes), KU LeuvenLeuven Autism Research (LAuRes), KU LeuvenDepartment of Rehabilitation Sciences, KU LeuvenLeuven Autism Research (LAuRes), KU LeuvenLeuven Autism Research (LAuRes), KU LeuvenLeuven Autism Research (LAuRes), KU LeuvenDepartment of Rehabilitation Sciences, KU LeuvenAbstract Background Intranasal administration of oxytocin is increasingly explored as a new approach to facilitate social development and reduce disability associated with a diagnosis of autism spectrum disorder (ASD). The efficacy of multiple-dose oxytocin administration in children with ASD is, however, not well established. Methods A double-blind, randomized, placebo-controlled trial with parallel design explored the effects of a 4-week intranasal oxytocin administration (12 IU, twice daily) on parent-rated social responsiveness (Social Responsiveness Scale: SRS-2) in pre-pubertal school-aged children (aged 8–12 years, 61 boys, 16 girls). Secondary outcomes included a questionnaire-based assessment of repetitive behaviors, anxiety, and attachment. Effects of oxytocin were assessed immediately after the administration period and at a follow-up, 4 weeks after the last administration. The double-blind phase was followed by a 4-week single-blind phase during which all participants received intranasal oxytocin. Results In the double-blind phase, both the oxytocin and placebo group displayed significant pre-to-post-improvements in social responsiveness and secondary questionnaires, but improvements were not specific to the intranasal oxytocin. Notably, in the single-blind phase, participants who were first allocated to intranasal placebo and later changed to intranasal oxytocin displayed a significant improvement in social responsiveness, over and above the placebo-induced improvements noted in the first phase. Participants receiving oxytocin in the first phase also showed a significant further improvement upon receiving a second course of oxytocin, but only at the 4-week follow-up. Further, exploratory moderator analyses indicated that children who received psychosocial trainings (3 or more sessions per month) along with oxytocin administration displayed a more pronounced improvement in social responsiveness. Limitations Future studies using larger cohorts and more explicitly controlled concurrent psychosocial trainings are warranted to further explore the preliminary moderator effects, also including understudied populations within the autism spectrum, such as children with co-occurring intellectual disabilities. Conclusions Four weeks of oxytocin administration did not induce treatment-specific improvements in social responsiveness in school-aged children with ASD. Future studies are warranted to further explore the clinical efficacy of oxytocin administration paired with targeted psychosocial trainings that stimulate socio-communicative behaviors. Trial registration The trial was registered with the European Clinical Trial Registry (EudraCT 2018-000769-35) on June 7th, 2018 ( https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-000769-35/BE ).https://doi.org/10.1186/s13229-023-00546-5Autism spectrum disorder (ASD)OxytocinSocial responsivenessRandomized controlled trial |
| spellingShingle | Nicky Daniels Matthijs Moerkerke Jean Steyaert Annelies Bamps Edward Debbaut Jellina Prinsen Tiffany Tang Stephanie Van der Donck Bart Boets Kaat Alaerts Effects of multiple-dose intranasal oxytocin administration on social responsiveness in children with autism: a randomized, placebo-controlled trial Molecular Autism Autism spectrum disorder (ASD) Oxytocin Social responsiveness Randomized controlled trial |
| title | Effects of multiple-dose intranasal oxytocin administration on social responsiveness in children with autism: a randomized, placebo-controlled trial |
| title_full | Effects of multiple-dose intranasal oxytocin administration on social responsiveness in children with autism: a randomized, placebo-controlled trial |
| title_fullStr | Effects of multiple-dose intranasal oxytocin administration on social responsiveness in children with autism: a randomized, placebo-controlled trial |
| title_full_unstemmed | Effects of multiple-dose intranasal oxytocin administration on social responsiveness in children with autism: a randomized, placebo-controlled trial |
| title_short | Effects of multiple-dose intranasal oxytocin administration on social responsiveness in children with autism: a randomized, placebo-controlled trial |
| title_sort | effects of multiple dose intranasal oxytocin administration on social responsiveness in children with autism a randomized placebo controlled trial |
| topic | Autism spectrum disorder (ASD) Oxytocin Social responsiveness Randomized controlled trial |
| url | https://doi.org/10.1186/s13229-023-00546-5 |
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