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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Pediatric, Healthy volunteers, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01], Psychiatry and Psychology [F] - Psychological Phenomena [F02], Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

Decision date (initial)

2023-09-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Fonds voor Wetenschappelijk Onderzoek - Vlaanderen · Apotheek A15 B.V.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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

Conditions and MedDRA coding

Autism Spectrum Disorder (ASD)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 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
2. 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)
3. 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
4. Intelligence Quotient above 70
5. Stable background treatment during four weeks prior to screening and in the period from intake to study visit
6. No planned changes in psychosocial interventions in the period from intake to study visit

Exclusion criteria 11

1. 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
2. Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
3. Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
4. Participation in an interventional Trial with an investigational medicinal product (IMP) or device
5. Significant hearing or vision impairments
6. Non-Dutch native speaker
7. Regular nasal obstruction or nosebleeds
8. Active medical problems: unstable seizures, significant physical illness (e.g., serious liver, renal, or cardiac pathology)
9. Subjects who recently have had previous chronic treatment with oxytocin
10. Known hypersensitivity to active substance or excipients in nasal sprays
11. Participants participating in the NT group must not have a total SRS T-score of ≥ 60

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 1

1. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Professor of the Study team

Public contact point

Organisation

UZ Leuven

Contact name

Professor of the Study team

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications