Recording stress signals in children and young people with autism
Biophysiological Characterization of Stress in Autism Spectrum Disorders: Analysis of Peripheral Markers of the ANS and the HPA Axis
This project will see if stress-related body signals like heart rate changes and cortisol behave differently in children and young people with autism who have frequent behavioral crises compared with neurotypical peers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 3 Years to 22 Years |
| Sex | All |
| Sponsor | Universite Cote d'Azur Academic / other |
| Locations | 1 site (Nice) |
| Trial ID | NCT07535801 on ClinicalTrials.gov |
What this trial studies
This observational project follows participants aged 3 to 22 to record physiological stress signals in everyday settings, focusing on the autonomic nervous system (for example heart rate variability) and the hypothalamic-pituitary-adrenal axis (for example cortisol). The study enrolls a group with autism and recurrent behavioral crises and a neurotypical control group to compare responses. Data are collected during real-life situations rather than only in the lab to capture natural stress reactions. The goal is to better characterize patterns that precede or accompany challenging behaviors in participants with limited communication.
Who should consider this trial
Good fit: Ideal participants are children and young people aged 3–22 with a clinical diagnosis of autism, recurrent behavioral crises (at least three episodes per week), enrolled in a participating care center, and with parental consent (and assent when appropriate).
Not a fit: Patients with known cardiac or hormonal disorders that interfere with physiological monitoring, those without frequent crises, or those unable to attend the participating site are unlikely to gain direct benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help predict behavioral crises earlier and guide personalized support or interventions to reduce harm.
How similar studies have performed: Previous research has reported altered heart rate variability and cortisol responses in some people with autism but findings have been inconsistent and fewer studies have captured stress responses in real-life settings.
Eligibility criteria
Show full inclusion / exclusion 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 Exclusion Criteria * Known cardiac or hormonal disorders affecting physiological measurements * Current diagnosis of neurodevelopmental or psychiatric disorder * Lack of parental or guardian consent
Where this trial is running
Nice
- CoBTEk — Nice, France (Recruiting)
Study contacts
- Study coordinator: Susanne THÜMMLER, MDC- HDR -PhD
- Email: Susanne.THUMMLER@univ-cotedazur.fr
- Phone: +33 4 92 03 03 26
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.