Oxytocin nasal spray with shared movement timing for children with autism
Tests oxytocin nasal spray with synchronized movement in autistic children.
Plain-language title generated from the registry record
Registry title: Enhancing social attunement in autism via interpersonal sensorimotor synchronization therapy combined with single-dose intranasal oxytocin administration
Key facts
- Where
- Leuven, BelgiumSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children aged 8 to 12 with autism spectrum disorder, and also children without autism as a comparison group. It tests a social synchronization therapy together with one dose of oxytocin nasal spray.
- Age
- 8 to 12 years old. The record header also lists a maximum age of 17 years.
- Sex
- Boys aged 8 to 12 can join. Girls can join only if they have not yet reached puberty.
- Disease stage
- Children in the autism group need a formal autism diagnosis made by a team of experienced clinicians (DSM-IV-TR or DSM-5). Verbal and visual-spatial scores on the WISC-V-NL must be above 70.
- Earlier treatment
- Psychiatric medication and psychosocial therapy must stay the same for four weeks before the intake visit and before the study visit. Recent long-term oxytocin treatment is not allowed.
- Biomarker or test result
- Children in the comparison group must not have a total SRS T-score of 60 or higher.
Main reasons for not taking part
- Known allergy to the active substance or to something in the nasal spray
- Other active medical, neurological or psychiatric conditions that could affect safety or the trial results (ADHD is allowed in the autism group)
- Anti-epileptic medication
- Significant hearing or vision problems
- Not a native Dutch speaker
Read by machine on 9 November 2026.
Where in Belgium
- UZ LeuvenLeuven, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorTrial details
- Who runs it
- UZ Leuven
- Trial code
- EU 2023-505253-41-01
- Record updated
- 9 October 2026
- Original description
The primary objective of this project is to determine the change from baseline treatment effects on dyadic attunement between children with autism spectrum disorder and the experimenterRead full original descriptionShow less
Enhancing social attunement in autism via interpersonal sensorimotor synchronization therapy combined with single-dose intranasal oxytocin administration
The primary objective of this project is to determine the change from baseline treatment effects on dyadic attunement between children with autism spectrum disorder and the experimenter
Inclusion: Voluntary written informed asent of the participant if possible and voluntary informed consent of their legally authorized representative has been obtained prior to any screening procedures; Participants participating in the ASD group must have a formal ASD diagnosis, established by a multidisciplinary team of experienced clinicians as defined by the DSM-IV-TR or DSM-5- criteria (Diagnostic and Statistical Manual of Mental Disorders); Male participants within an age-range of 8 to 12 years old; only female participants at pre-puberty within this age-range on the day of the study visit; Estimated Verbal Comprehension Index and Visiual Spatial Index determined by the WISC-V-NL above 70; Psychopharmacological medication and psychosocial therapy must remain stable during four weeks prior to the intake visit and during four weeks prior to the study visit.
Exclusion: Any anti-epileptic medication and/or any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial; Subjects who recently have had previous chronic treatment with oxytocin; Known hypersensitivity to active substance or excipients in nasal sprays; Participants participating in the NT group or their first-degree relatives has a diagnosis of autism, and/or any psychiatric or neurological disorder that may affect the safety of the participant or the integrity of the trial; Any active medical condition (neurological, psychiatric, developmental, gastrointestinal, motoric disorders, etc., other than ASD or comorbid ADHD in participants with ASD) that may affect the safety of the participant, the integrity of the trial, or the effect of the IMP; Participants participating in the NT group must not have a total SRS T-score of ≥ 60; Participation in an interventional Trial with an investigational medicinal product (IMP) or device; Significant hearing or vision impairments; Non-Dutch native speaker; Regular nasal obstruction or nosebleeds.