Autism Spectrum Disorder With Intellectual Deficiency
Conditions
Keywords
autism spectrum disorder, stress biomarkers, autonomic nervous system, heart rate variability, challenging behavior, ecological assessment, profound autism, hypothalamic-pituitary-adrenal axis, skin conductance, salivary cortisol, salivary alpha amylase
Brief summary
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: * Do physiological stress signals differ between individuals with ASD and those without ASD? * Are there differences in physiological stress responses between individuals with ASD and non-ASD participants? * Can physiological markers help identify stress earlier in people with autism? 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: * Wear a wrist device during the day that measures heart rate, heart rate variability, skin conductance, skin temperature, and movement * Provide saliva samples in the morning and afternoon to measure stress hormones such as cortisol and alpha-amylase * Have additional saliva samples collected after behavioural crises or stressful events when possible * Be observed by a trained researcher who records behavioural events and the surrounding context 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.
Interventions
None listed
Sponsors
Universite Cote d'Azur
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 22 Years
Healthy volunteers
Yes
Inclusion criteria
1. Autism Spectrum Disorder (ASD) Group Inclusion Criteria * Age between 3 and 22 years * Clinical diagnosis of autism spectrum disorder according to established diagnostic criteria * Presence of recurrent behavioral crises (minimum of three episodes per week) * Enrollment in a participating institution or care structure * Written informed consent provided by a parent or legal guardian * Assent from the participant when developmentally appropriate
Exclusion criteria
* Known cardiac or homonal disorders that may interfere with physiological monitoring * Lack of consent from parents or legal guardians 2. Control Group (Neurotypical Participants) Inclusion Criteria * Age between 3 and 22 years * No diagnosis of autism spectrum disorder or other neurodevelopmental disorder * No history of major psychiatric or neurological disorders * Written informed consent provided by a parent or legal guardian * Assent from the participant when developmentally appropriate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Autonomic Physiological Stress Markers During Behavioral Stress Episodes | Continuous monitoring during the 4-day observation period (approximately 8 hours per day). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Cortisol Concentration | Collected during the 4-day observation period (morning, afternoon, and post-crisis when applicable). | 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. |
| Salivary Alpha-Amylase Activity | Collected during the 4-day observation period (morning, afternoon, and post-crisis when applicable). | 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. |
| Frequency and Duration of Behavioral Stress Episodes | Recorded continuously during the 4-day observation period. | 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 |
Countries
France
Contacts
CONTACTSusanne THÜMMLER, MDC- HDR -PhD
Outcome results
None listed