Effects of multiple-dose intranasal oxytocin administration on social responsiveness in children with autism: a randomized, placebo-controlled trial

Daniels, Nicky; Moerkerke, Matthijs; Steyaert, Jean; Bamps, Annelies; Debbaut, Edward; Prinsen, Jellina; Tang, Tiffany; Van der Donck, Stephanie; Boets, Bart; Alaerts, Kaat

doi:10.1186/s13229-023-00546-5

Molecular Autism

Table 2 Effects of oxytocin nasal spray administration on primary and secondary outcome measures of the double-blind phase I

From: Effects of multiple-dose intranasal oxytocin administration on social responsiveness in children with autism: a randomized, placebo-controlled trial

Outcome measure	Within-group								Between-group
	Oxytocin group				Placebo group				Between-group
	n	mean ± SD	t-value	p-value	n	mean ± SD	t-value	p-value	Cohen's d	t-value	p-value
T1 Post-assessment
Primary outcome
SRS-2 total raw score	38	− 4.08 ± 10.05	− 2.50	0.017	38	− 4.55 ± 10.23	-2.74	0.009	0.05	0.20	0.839
Secondary outcomes—parent report
RBS-R	38	− 6.53 ± 11.26	− 3.57	0.001	38	− 6.76 ± 9.92	− 4.20	0.000	0.02	0.10	0.923
SCARED Parent	38	− 0.47 ± 11.61	− 0.25	0.803	38	− 4.95 ± 11.93	− 2.56	0.015	0.38	1.66	0.102
Secondary outcomes—self-report
SCARED child	38	− 4.74 ± 11.47	− 2.55	0.015	39	− 3.38 ± 11.32	− 1.87	0.070	− 0.12	-0.52	0.604
ASCQ secure	38	− 0.89 ± 2.42	− 2.27	0.029	39	− 0.92 ± 2.93	− 1.97	0.057	0.01	0.05	0.963
ASCQ anxious	38	− 0.92 ± 3.24	− 1.75	0.088	39	− 1.00 ± 2.50	− 2.50	0.017	0.03	0.12	0.905
ASCQ avoidant	38	− 0.29 ± 3.73	− 0.48	0.636	39	− 1.08 ± 3.30	− 2.04	0.049	0.22	0.98	0.330
Attachment mother anxiety	38	0.76 ± 2.95	1.59	0.120	39	− 0.33 ± 2.57	− 0.81	0.423	0.40	1.74	0.086
Attachment mother avoidance	38	− 0.21 ± 3.18	− 0.41	0.686	39	− 0.82 ± 3.94	− 1.30	0.201	0.17	0.75	0.458
Attachment mother secure	38	0.24 ± 4.18	0.35	0.729	39	− 0.18 ± 2.55	− 0.44	0.663	0.12	0.53	0.598
T2 follow-up assessment
Primary Outcome
SRS-2 total raw score	38	− 6.76 ± 11.19	− 3.73	0.001	39	− 5.38 ± 13.42	− 2.51	0.017	− 0.11	-0.49	0.626
Secondary outcomes—parent report
RBS-R	38	− 4.55 ± 10.76	− 2.61	0.013	39	− 4.41 ± 8.28	− 3.33	0.002	− 0.01	− 0.07	0.948
SCARED parent	38	− 2.92 ± 11.53	− 1.56	0.127	39	− 5.38 ± 9.52	− 3.53	0.001	0.23	1.02	0.309
Secondary outcomes—self-report
SCARED child	38	− 5.97 ± 9.84	− 3.74	0.001	39	− 6.36 ± 13.38	− 2.97	0.005	0.03	0.14	0.886
ASCQ anxious	38	− 1.00 ± 3.92	− 1.57	0.125	39	− 2.38 ± 3.75	− 3.98	0.000	0.36	1.58	0.117
ASCQ avoidant	38	− 0.84 ± 4.04	− 1.28	0.207	39	− 1.46 ± 3.09	− 2.95	0.005	0.17	0.76	0.452
ASCQ secure	38	− 1.37 ± 3.34	− 2.53	0.016	39	− 0.82 ± 3.78	− 1.35	0.184	− 0.15	− 0.67	0.503
Attachment mother anxiety	38	0.84 ± 3.11	1.67	0.103	39	0.08 ± 3.07	0.16	0.877	0.25	1.09	0.281
Attachment mother avoidance	38	− 0.61 ± 3.89	− 0.96	0.343	39	− 0.67 ± 3.50	− 1.19	0.241	0.02	0.07	0.942
Attachment mother secure	38	0.66 ± 3.93	1.03	0.308	39	0.13 ± 2.83	0.28	0.779	0.16	0.68	0.498

Change from baseline scores are listed separately for the post-assessment session (immediately after the 4-week nasal spray administration period, T1) and the follow-up assessment (4 weeks after cessation of the nasal spray administration period, T2)
For all outcomes, except ASCQ secure and Attachment mother secure, negative change from baseline scores indicate pre-to-post-improvement
Values printed in bold indicate p-values < 0.05
SRS-2 social responsiveness scale, RBS-R repetitive behavior scale-revised, SCARED screen for child anxiety related disorders, ASCQ attachment style classification questionnaire

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ISSN: 2040-2392

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