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Clinical Trials/2023-505253-41-01
2023-505253-41-01RecruitingPhase 3

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

UZ Leuven1 site in 1 country140 target enrollmentStarted: March 5, 2024Last updated:
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Trial Snapshot

Phase
Phase 3
Status
Recruiting
Sponsor
UZ Leuven
Enrollment
140
Locations
1
Primary Endpoint
The primary endpoint of this project is the change from baseline treatment effects on dyadic attunement in children with ASD and the experimenter, determined by multimodal measures of neurophysiological and behavioral responses as defined in the study protocol, during screen-based and real-life social interaction paradigms
Study OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Eligibility Criteria

Ages
0 years to 17 years (0-17 Years)
Accepts Healthy Volunteers
Yes

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
  • •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 Criteria

  • •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.
  • •Participants participating in the NT group must not have a total SRS T-score of ≥ 60
  • •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.
  • •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
  • •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
  • •Subjects who recently have had previous chronic treatment with oxytocin

Outcomes

Primary Outcomes

The primary endpoint of this project is the change from baseline treatment effects on dyadic attunement in children with ASD and the experimenter, determined by multimodal measures of neurophysiological and behavioral responses as defined in the study protocol, during screen-based and real-life social interaction paradigms

The primary endpoint of this project is the change from baseline treatment effects on dyadic attunement in children with ASD and the experimenter, determined by multimodal measures of neurophysiological and behavioral responses as defined in the study protocol, during screen-based and real-life social interaction paradigms

Secondary Outcomes

  • The secondary endpoint of this project is the change from baseline treatment effects on post-intervention endogenous oxytocin and cortisol levels measured in saliva samples

Investigators

Sponsor
UZ Leuven
Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Professor of the Study team

Scientific

UZ Leuven

Study Sites (1)

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