Oxytocin's social and stress-regulatory effects in children with autism and intellectual disability: a protocol for a randomized placebo-controlled trial

What Was Tested

Researchers studied Oxytocin in this clinical study publication.

To assess the possibility of retention and/or late-emerging effects, outcomes will be assessed immediately after the administration regime, and at two follow-up sessions, four-weeks and six months after administration.

Why It Was Studied

The trial was registered on the 9th of December 2022 at the European Clinical Trial Registry (EudraCT 2022-002423-36) and on 20th of September the trial was transferred to the EU Clinical Trial Register (EU CT 2024-513436-14).

Who Took Part

According to the abstract, 80 children were involved.

The age groups tagged for this paper are young children, children and teenagers, both men and women.

Clinical-behavioral as well as stress-regulatory effects of oxytocin will be evaluated using the Autism Treatment Evaluation Checklist (ATEC), the Brief Observation of Social Communication Change (BOSCC) expert rating scale, and measurements of high-frequency heart rate variability (HF-HRV), a validated index of parasympathetic autonomic nervous system activity.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

The children were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Neither the children nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Some children received a placebo instead of Oxytocin, giving a reference point.

What Was Measured

PubMed files the paper under topics including Oxytocin, Intellectual Disability, Autism Spectrum Disorder, Stress, Psychological, Autistic Disorder, Randomized Controlled Trials as Topic and Social Behavior.

The authors tagged it with the keywords Children and Clinical trial.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Oxytocin in 80 children.

Its findings take up roughly 2 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2025 (BMC psychiatry), a journal based in England.

More context: the Oxytocin compound page, all human trials.