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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 intranasal oxytocin, a hormone that is naturally produced in the body and is known to play a role in social bonding and behavior. The oxytocin will be administered as a nasal spray called Syntocinon. Additionally, the study will use Sodium Chloride Nasal Drops 0.9% as a comparison treatment.

The purpose of the study is to explore how this treatment might improve social interactions between children with ASD and others. Participants will receive the treatment through a nasal spray, and the study will observe changes in their social interactions. The study will also measure levels of oxytocin and another hormone called cortisol in saliva samples to see how they change after the treatment.

The study will take place over a short period, with participants receiving the treatment and then being observed for any changes in their social behavior. The goal is to better understand how oxytocin might help improve social skills in children with ASD, potentially leading to new ways to support those with the condition.

The research process

The trial runs in 6 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
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes verifying a formal diagnosis of autism spectrum disorder (ASD) by a team of experienced clinicians, as well as ensuring an intelligence quotient above 70. Participants must be male, aged 8 to 12, or female at pre-puberty within this age range.
Step 3
Stable treatment period
Maintain stable background treatment for four weeks prior to the study visit. No changes in psychosocial interventions should occur from intake to the study visit.
Step 4
Study visit
During the study visit, a single dose of intranasal oxytocin will be administered using a nasal spray solution. This is part of the therapy aimed at enhancing social attunement in autism.
Step 5
Observation and interaction
Engage in screen-based and real-life social interaction paradigms. The primary goal is to observe changes in dyadic attunement between the participant and the experimenter, using various measures of neurophysiological and behavioral responses.
Step 6
Post-intervention assessment
After the intervention, saliva samples will be collected to measure changes in endogenous oxytocin and cortisol levels. This helps assess the secondary effects of the treatment.

Who can join the trial?

6 criteria

Voluntary written informed agreement from the participant, if possible, and voluntary informed consent from their legally authorized representative must be obtained before any screening procedures.
Participants in the ASD group must have a formal diagnosis of Autism Spectrum Disorder (ASD), confirmed by a team of experienced clinicians using the criteria from the DSM-IV-TR or DSM-5 (Diagnostic and Statistical Manual of Mental Disorders).
Male participants must be between the ages of 8 to 12 years old. Female participants must be in pre-puberty within this age range on the day of the study visit.
Participants must have an Intelligence Quotient (IQ) above 70. IQ is a measure of a person's ability to think and reason.
Participants must have a stable background treatment for at least four weeks before screening and during the period from intake to the study visit.
No planned changes in psychosocial interventions are allowed from the time of intake to the study visit. Psychosocial interventions are treatments that involve both psychological and social aspects.

Who cannot join the trial?

10 criteria

Participants cannot have any other major medical or psychiatric conditions that could interfere with the study.
Participants should not have a history of severe allergies, especially to medications.
Participants cannot be currently participating in another clinical trial.
Participants should not have a history of substance abuse or dependence in the past year.
Participants cannot have any significant vision or hearing impairments that are not corrected.
Participants should not have any neurological disorders, such as epilepsy, that are not well-controlled.
Participants cannot have any genetic disorders that affect brain function.
Participants should not have any severe behavioral problems that could interfere with the study.
Participants cannot have any infectious diseases that could be transmitted to others.
Participants should not have any conditions that require regular use of medications that could interfere with the study.

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Katholieke Universiteit te Leuven
Leuven, Belgium

Trial locations

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Investigated drugs

Oxytocin is a hormone that is naturally produced in the body. It is often called the "love hormone" because it plays a role in social bonding, trust, 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 between children with autism and others. The idea is that by enhancing these social bonds, children with autism might find it easier to connect and communicate with people around them.

Oxytocin

What is already known about the treatment

Oxytocin – Oxytocin is administered as a nasal spray, making it easy to use. It is currently being studied for its potential benefits in treating Autism Spectrum Disorder (ASD), particularly in improving social interactions. The main therapeutic indication is to enhance social attunement, which means helping individuals with ASD better connect and communicate with others. 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, behavior, and social interaction. It typically appears in early childhood and is characterized by challenges in understanding social cues, forming relationships, and engaging in typical communication. Individuals with ASD may exhibit repetitive behaviors, have specific interests, and experience sensory sensitivities. The progression of ASD varies widely among individuals, with some showing improvements in social skills and communication over time, while others may continue to face significant challenges. The condition is lifelong, and its manifestations can change as a person grows and develops.