Recording Stress Biomarkers in Autism Spectrum Disorders

NCT07535801 | Recruiting

• 1 other identifier: 25.03788.000456
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder With Intellectual Deficiency

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

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (3)

• Salivary Cortisol Concentration

  Collected during the 4-day observation period (morning, afternoon, and post-crisis when applicable).

• Salivary Alpha-Amylase Activity

  Collected during the 4-day observation period (morning, afternoon, and post-crisis when applicable).

• Frequency and Duration of Behavioral Stress Episodes

  Recorded continuously during the 4-day observation period.

Other Outcomes (3)

• Behavioral Problems Inventory (BPI) Scores

  Assessed at baseline.

• Nonverbal Cognitive Functioning

  Assessed Day 1.

• Adaptive Functioning

  Assessed at baseline.

Study Arms (2)

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.

Eligibility Criteria

• Age: 3 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Known cardiac or homonal disorders that may interfere with physiological monitoring
• Lack of consent from parents or legal guardians
• 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
• Known cardiac or hormonal disorders affecting physiological measurements
• Current diagnosis of neurodevelopmental or psychiatric disorder
• Lack of parental or guardian consent

Sponsors & Collaborators

• Universite Cote d'Azur: lead

Study Sites (1)

CoBTEk

Nice, 06100, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Susanne THÜMMLER, MDC- HDR -PhD

CONTACT

+33 4 92 03 03 26; Susanne.THUMMLER@univ-cotedazur.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigor

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: April 17, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)