CoBTEk
Nice, 06100, France
Location status: Recruiting
NCT Number: NCT07535801
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.
Interested in participating?
Request Info3 year–22 year
All sexes
Observational
Nice, 06100, France
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Exclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Assessed at baseline.
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.
Time frame: Assessed Day 1.
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.
Time frame: Assessed at baseline.
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.
Contact information is provided by the study sponsor or research team.
Universite Cote d'Azur
Other
Biophysiological Characterization of Stress in Autism Spectrum Disorders: Analysis of Peripheral Markers of the ANS and the HPA Axis
Acronym: STRESSDEFIS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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