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Observational Study Recording Stress Biomarkers in Autism Spectrum Disorders

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Summary

The National Institutes of Health registered an observational clinical trial (NCT07535801) studying how physiological stress signals differ between children and young people with autism spectrum disorder (ASD) and non-ASD participants. The study will monitor two biological stress systems — the autonomic nervous system and the hypothalamic-pituitary-adrenal axis — in real-life environments including schools, homes, and care institutions. Participants with ASD who also have intellectual deficiency will be compared against a control group of typically developing peers.

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What changed

NIH published a ClinicalTrials.gov registry entry for NCT07535801, an observational study titled 'Recording Stress Biomarkers in Autism Spectrum Disorders.' The study seeks to determine whether physiological stress signals — specifically autonomic nervous system responses (heart rate, perspiration) and hypothalamic-pituitary-adrenal axis hormones (cortisol) — differ between individuals with ASD and non-ASD controls, and whether these markers could enable earlier stress identification in people with limited communication abilities. Participants will be monitored during normal daily activities across natural settings.

Clinical investigators and healthcare providers conducting pediatric autism research should note this as a signal of ongoing NIH-funded research into stress physiology and behavioral prediction in ASD populations. The registry entry does not impose compliance obligations but may inform future clinical guidance on stress management protocols for individuals with autism.

Archived snapshot

Apr 18, 2026

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Recording Stress Biomarkers in Autism Spectrum Disorders

Observational NCT07535801 Kind: OBSERVATIONAL Apr 17, 2026

Abstract

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....

Conditions: Autism Spectrum Disorder With Intellectual Deficiency

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Last updated

Classification

Agency
NIH
Published
April 17th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07535801

Who this affects

Applies to
Clinical investigators Healthcare providers
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Biomarker research Observational study
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Public Health Pharmaceuticals Medical Devices

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