2023-505253-41-01RecruitingPhase 3
Enhancing social attunement in autism via interpersonal sensorimotor synchronization therapy combined with single-dose intranasal oxytocin administration
Source: EU CTIS (euclinicaltrials.eu) · Last updated 9 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 5 Dec 2023
- Start date
- 18 Jun 2024
- Lead sponsor
- UZ Leuven
- Diseases
- Autism
- EU CT number
- 2023-505253-41-01
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 140
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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
Age in the registry: - to 17 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven | Leuven | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.