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Enhancing social attunement in autism via interpersonal sensorimotor synchronization therapy combined with single-dose intranasal oxytocin administration
EU CTIS ID: 2023-505253-41-01
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.