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The goal of this observational study is to learn how stress affects children and young people with autism spectrum disorder (ASD). Many individuals with autism experience strong stress reactions that may lead to challenging behaviours such as agitation, withdrawal, aggression, or self-injury. These behaviours can be difficult to predict, especially in people who have limited communication abilities.
Researchers want to better understand how the body reacts to stress in real-life situations. The study focuses on two main biological systems involved in the stress response:
the autonomic nervous system, which produces fast reactions such as changes in heart rate and sweating, and the hypothalamic-pituitary-adrenal axis, which produces slower hormonal responses such as cortisol.
The main questions the study aims to answer are:
Researchers will compare children and young people with autism to a control group of participants without autism to see whether their stress responses differ.
Participants will take part in monitoring during their normal daily activities. This allows researchers to observe stress responses in natural environments such as school, home, or specialized care institutions.
Participants will:
Researchers will combine physiological data, behavioural observations, and contextual information such as physical activity, environmental conditions, and daily routines. This will help identify patterns of stress in everyday life.
The results of this study may help researchers better understand the physiology of stress in autism and support the future development of wearable systems that could detect stress early and help prevent behavioural crises.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autism Spectrum Disorder Participants | The cohort includes children and adolescents aged 3 to 22 years with a clinical diagnosis of autism spectrum disorder (ASD). Participants are recruited from specialized medico-social institutions providing care and educational support for individuals with neurodevelopmental disorders. To be eligible for inclusion, participants must present frequent challenging behaviours, defined as at least three behavioural crises per week (e.g., agitation, aggression, self-injurious behaviours, or severe emotional dysregulation). Participants must also be able to tolerate the placement of a wearable physiological monitoring device during daytime activities. Participants with known cardiac disorders or hormonal disorders that may affect physiological stress measurements are excluded. Written informed consent is obtained from parent | ||
| Neurotypical Participants | The control cohort includes children and adolescents aged 3 to 22 years from the general population. Participants in this group do not have a diagnosis of autism spectrum disorder or other neurodevelopmental disorders. Control participants are recruited through community outreach, schools and information provided to families. They are selected to be comparable to the ASD group in terms of age and sex as closely as possible. Participants with known cardiac disorders or hormonal disorders that may affect physiological stress measurements are excluded. Written informed consent is obtained from parents or legal guardians prior to participation. The control participants follow the same monitoring procedures as the ASD group during their usual daily activities. |
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| Measure | Description | Time Frame |
|---|---|---|
| Autonomic Physiological Stress Markers During Behavioral Stress Episodes | Continuous autonomic physiological signals are recorded using a wearable device during daytime monitoring. The primary outcome consists of variations in autonomic stress markers including heart rate (HR), heart rate variability (HRV), and electrodermal activity (EDA) in relation to behavioral stress events and crisis episodes recorded during observation. These physiological signals will be analyzed to identify changes associated with stress states and behavioral dysregulation in naturalistic settings. | Continuous monitoring during the 4-day observation period (approximately 8 hours per day). |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary Cortisol Concentration | Salivary cortisol levels are measured as a biomarker of hypothalamic-pituitary-adrenal (HPA) axis activation. Samples are collected twice daily (morning and afternoon) and after behavioral crisis events when feasible. Cortisol concentrations are quantified using enzyme-linked immunosorbent assay (ELISA) techniques. | Collected during the 4-day observation period (morning, afternoon, and post-crisis when applicable). |
| Measure | Description | Time Frame |
|---|---|---|
| Behavioral Problems Inventory (BPI) Scores | Parents complete the Behavioral Problems Inventory (BPI) questionnaire to assess the frequency and severity of self-injurious, stereotyped, and aggressive behaviors in everyday life. The BPI provides a standardized behavioral profile for each participant. | Assessed at baseline. |
Autism Spectrum Disorder (ASD) Group Inclusion Criteria
Exclusion Criteria:
Control Group (Neurotypical Participants) Inclusion Criteria
Exclusion Criteria
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The study population consists of children and adolescents aged 3 to 22 years. Two groups are included: individuals diagnosed with autism spectrum disorder (ASD) presenting recurrent behavioral crises, and a neurotypical control group without neurodevelopmental disorders. Participants with ASD are recruited from specialized medico-social institutions providing care and educational support for individuals with neurodevelopmental conditions. Control participants are recruited from the general population through community outreach and school-based information to families.
Participants are observed during their regular daily activities in naturalistic environments such as specialized institutions, schools, or home settings. Continuous physiological monitoring, behavioral observation, and biological sampling are conducted during daytime institutional sessions.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susanne THÜMMLER, MDC- HDR -PhD | Contact | +33 4 92 03 03 26 | Susanne.THUMMLER@univ-cotedazur.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CoBTEk | Recruiting | Nice | 06100 | France |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Saliva samples will be collected from participants to measure biomarkers of the stress response. Samples are obtained using a passive saliva collection method with absorbent swabs placed briefly in the mouth. Saliva is collected twice daily (morning and afternoon) to assess diurnal stress hormone rhythms. Additional samples may be collected after behavioral crises or stressful events when possible. Samples are labeled with a participant code and timestamp, immediately refrigerated, and frozen at -20°C within two hours of collection. Saliva samples are later analyzed to measure cortisol and salivary alpha-amylase, which reflect activation of the hypothalamic-pituitary-adrenal (HPA) axis and sympathetic nervous system. These biomarkers provide objective indicators of physiological stress responses.
| Salivary Alpha-Amylase Activity | Salivary alpha-amylase activity is measured as an indicator of sympathetic nervous system activation. Samples are collected using passive saliva swabs and analyzed using a kinetic enzymatic assay. | Collected during the 4-day observation period (morning, afternoon, and post-crisis when applicable). |
| Frequency and Duration of Behavioral Stress Episodes | Behavioral stress indicators and crisis episodes are recorded using a structured Antecedent-Behavior-Consequence (ABC) observation grid completed by the investigator during the monitoring period. Outcomes include the frequency and duration of behavioral dysregulation events such as agitation, self-injurious behavior, aggressive behavior, withdrawal, and emotional distress | Recorded continuously during the 4-day observation period. |
| Nonverbal Cognitive Functioning |
Nonverbal cognitive ability is assessed using the Leiter International Performance Scale - Third Edition (Leiter-3), a nonverbal intelligence test designed for individuals aged 3 to 75 years and suitable for participants with communication difficulties. |
| Assessed Day 1. |
| Adaptive Functioning | Adaptive functioning is evaluated using the Vineland Adaptive Behavior Scales, which measure communication, daily living skills, socialization, and motor skills through caregiver interview or questionnaire. | Assessed at baseline. |