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NCT Number: NCT07535801

Recording Stress Biomarkers in Autism Spectrum Disorders

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.

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Key information

Age range

3 year–22 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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
  • 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

Exclusion criteria

  • Known cardiac or hormonal disorders affecting physiological measurements
  • Current diagnosis of neurodevelopmental or psychiatric disorder
  • Lack of parental or guardian consent

Treatment and study plan

Primary outcomes

  1. Autonomic Physiological Stress Markers During Behavioral Stress Episodes

    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.

Secondary outcomes

  1. Salivary Cortisol Concentration

    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.

  2. Salivary Alpha-Amylase Activity

    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.

  3. Frequency and Duration of Behavioral Stress Episodes

    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

Other outcomes

  1. Behavioral Problems Inventory (BPI) Scores

    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.

  2. Nonverbal Cognitive Functioning

    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.

  3. Adaptive Functioning

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Susanne THÜMMLER, MDC- HDR -PhD

CONTACT

[email protected]

+33 4 92 03 03 26

Sponsors and collaborators

Lead sponsor

Universite Cote d'Azur

Other

Registry information

Official study title

Biophysiological Characterization of Stress in Autism Spectrum Disorders: Analysis of Peripheral Markers of the ANS and the HPA Axis

Acronym: STRESSDEFIS

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 17, 2026
Registry last updated
Apr 23, 2026

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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