Enhancing social attunement in autism via interpersonal sensorimotor synchronization therapy combined with single-dose intranasal oxytocin administration - S67699

Z Leuven0 sites140 target enrollmentDecember 5, 2023

Overview

No summary available.

Registry

who.int

Start Date

December 5, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Z Leuven

•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, Intelligence Quotient above 70, Stable background treatment during four weeks prior to screening and in the period from intake to study visit, No planned changes in psychosocial interventions in the period from intake to study visit

•Participant has a (history of) neurological (stroke, concussion, epilepsy, etc.), psychiatric or developmental disorder (other than ASD or comorbid ADHD in participants with ASD) or a first\-degree relative has this disorder, Known hypersensitivity to active substance or excipients in nasal sprays, Participants participating in the NT group must not have a total SRS T\-score of \= 60, Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol, Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial, 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, Active medical problems: unstable seizures, significant physical illness (e.g., serious liver, renal, or cardiac pathology), Subjects who recently have had previous chronic treatment with oxytocin