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Study on Improving Social Interaction in Children with Autism Using Oxytocin Nasal Spray and Therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Autism Spectrum Disorder (ASD), a condition that affects social interaction and communication. The study will use a treatment involving a single dose of oxytocin, which is administered as a nasal spray. Oxytocin is a hormone that plays a role in social bonding and behavior. The nasal spray used in the study is called Syntocinon. Participants will also receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

The purpose of the study is to explore how this treatment might improve social interactions between children with autism and others. The study will involve children with autism participating in activities designed to measure their social engagement and responses. These activities will include both screen-based and real-life social interactions. The study will also look at changes in natural levels of oxytocin and cortisol, a stress hormone, in saliva samples after the treatment.

The trial will take place over a short period, with the treatment being administered once. The children will be observed for changes in their social behavior and physiological responses. The goal is to understand if the nasal spray can enhance social attunement, which means improving the ability to connect and interact with others, in children with autism. This research aims to provide insights into potential new ways to support social development in children with ASD.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, ensure that voluntary written informed assent is provided if possible. Additionally, voluntary informed consent from a legally authorized representative is required before any procedures begin.
Step 2
Eligibility confirmation
Eligibility is confirmed based on specific criteria. Participants must have a formal diagnosis of autism spectrum disorder (ASD) established by a team of experienced clinicians. Male participants should be between 8 to 12 years old, while female participants should be pre-puberty within this age range on the day of the study visit.
Participants must have an estimated verbal comprehension index and visual spatial index above 70, as determined by the WISC-V-NL test. Any psychopharmacological medication and psychosocial therapy should remain stable for four weeks prior to the intake visit and during four weeks before the study visit.
Step 3
Study visit
During the study visit, a single dose of intranasal oxytocin is administered using a nasal spray solution called Syntocinon 40 IE/ml. This is done to assess its effects on social attunement in children with ASD.
The primary goal is to observe changes in social interaction between the participant and the experimenter, using various measures of neurophysiological and behavioral responses.
Step 4
Post-intervention assessment
After the intervention, changes in endogenous oxytocin and cortisol levels are measured using saliva samples. This helps in understanding the biological effects of the treatment.

Who can join the trial?

5 criteria

The participant must provide voluntary written informed assent if possible, and their legally authorized representative must provide voluntary informed consent before any screening procedures. This means both the participant and their guardian agree to join the study after understanding what it involves.
The participant must have a formal diagnosis of Autism Spectrum Disorder (ASD), confirmed by a team of experienced doctors using specific guidelines (DSM-IV-TR or DSM-5 criteria).
The participant must be a male aged between 8 to 12 years old, or a female who has not yet reached puberty within this age range on the day of the study visit.
The participant must have an Estimated Verbal Comprehension Index and Visual Spatial Index above 70, as determined by a specific test called the WISC-V-NL. This means they have certain levels of understanding and visual skills.
If the participant is taking any psychopharmacological medication (medicines that affect the mind) or undergoing psychosocial therapy (therapy that involves social and psychological aspects), these must remain unchanged for four weeks before the initial visit and four weeks before the study visit.

Who cannot join the trial?

10 criteria

Participants must not have any other major medical or psychiatric conditions that could interfere with the study.
Participants should not be taking medications that might affect the study results.
Participants must not have a history of severe allergies, especially to any components used in the study.
Participants should not have participated in another clinical trial recently, as this could affect the results.
Participants must not have any significant vision or hearing impairments that cannot be corrected with glasses or hearing aids.
Participants should not have any legal or social issues that might prevent them from completing the study.
Participants must not be pregnant or planning to become pregnant during the study period.
Participants should not have a history of substance abuse or dependency.
Participants must not have any infectious diseases that could be transmitted to others.
Participants should not have any conditions that require regular use of steroids or other immune-suppressing drugs.

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Katholieke Universiteit te Leuven
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Leuven, Belgium

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Investigated drugs

Oxytocin
is a hormone that is naturally produced in the body. It plays a role in social bonding and emotional connection. In this clinical trial, oxytocin is administered as a nasal spray to see if it can help improve social interactions and connections in children with autism. The idea is that by giving oxytocin, it might enhance the ability of these children to connect and communicate better with others.
Interpersonal Sensorimotor Synchronization Therapy
is a type of therapy that involves activities designed to help improve coordination and timing between two people. In this trial, the therapy is used to help children with autism better synchronize their movements and actions with another person, like a therapist. The goal is to see if this can help improve their social interactions and ability to connect with others.

Oxytocin

What is already known about the treatment

Oxytocin – Oxytocin is administered as a nasal spray, which means it is sprayed into the nose. Currently, oxytocin is being studied for its potential benefits in treating Autism Spectrum Disorder (ASD), particularly in improving social interactions. The main therapeutic use being explored is its ability to enhance social attunement, which is the ability to connect and synchronize with others in social settings. At the molecular level, oxytocin works by binding to specific receptors in the brain, which can influence social behavior and emotional responses. It is classified as a hormone and neurotransmitter, known for its role in social bonding and emotional regulation.

Investigated diseases

Autism Spectrum Disorder (ASD) – Autism Spectrum Disorder is a developmental condition that affects communication and behavior. It is characterized by challenges with social skills, repetitive behaviors, and speech and nonverbal communication. The symptoms of ASD can vary widely in severity and may include difficulties in understanding social cues, forming relationships, and expressing emotions. Individuals with ASD may also exhibit restricted interests and engage in repetitive activities. The progression of ASD is unique to each individual, with some experiencing improvements in symptoms over time, while others may continue to face challenges throughout their lives. The condition is typically identified in early childhood, although signs can sometimes be observed earlier.