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

Phase 1

Recruiting

Conditions: Autism Spectrum Disorder (ASD)
Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
Therapeutic area: Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]
Therapeutic area: Psychiatry and Psychology [F] - Psychological Phenomena [F02]

Registration Number: CTIS2023-505253-41-01

Lead Sponsor: Z Leuven

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 140

Inclusion Criteria

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

Exclusion Criteria

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