Study on factors influencing neurodevelopmental disorders in mothers and children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the determinants of neurodevelopmental disorders, particularly Autism Spectrum Disorder (ASD), by examining both genetic and environmental factors. It involves collecting data through questionnaires, biospecimen collection, and neurodevelopmental assessments from pregnant mothers and their children. The study will include both high-risk and low-risk cohorts, focusing on families with a history of ASD. By understanding the multifactorial origins of these disorders, the research seeks to improve early detection and intervention strategies.

Why it matters

Who can join: the full rules

INCLUSION CRITERIA:

General inclusion criteria (High risk and Low risk cohorts)

Mother:

* Be pregnant (single or multiple pregnancy), at least 16 weeks of amenorrhea,
* Have at least one biological child of 24 months or older,
* At least 18 years of age

Father:

* Be the biological father of the unborn child,
* At least 18 years of age

Unborn Child:

\- Have a woman study participant as mother.

Specific inclusion criteria for the High risk cohort:

* Autistic sibling: refers to the biological child(ren) of the mother and/or father participating in the study and being the parent(s) of the unborn child
* Be at least 24 months old and less than 18 years old,
* Have a confirmed diagnosis of Autism Spectrum Disorder based on medical records. If in doubt, the SRS-2 (Social Responsiveness Scale for Adults) and PEDS-DM (Parents' Evaluation of developmental status) questionnaires will be completed. Only children with positive scores on one of these questionnaires will be included after validation of the diagnosis by an expert committee,
* In case of several children with Autism Spectrum Disorder based in the siblings, only the last born will be included.

Remarks:

* Autism Spectrum Disorder siblings resulting from a medically assisted procreation are eligible provided that part of the genetic heritage is common to that of the mother or father of the unborn child participating in the study.
* If the father does not live with the mother of the unborn child, his participation is not required and does not preclude the participation of other family members.

EXCLUSION CRITERIA:

General non-inclusion criteria (High risk and Low risk cohorts):

Father and mother:

* Unable to understand French or the study questionnaires
* Participant on protective measures (guardianship or curatorship) or deprived of liberty by judicial or administrative decision, or subject to a legal protection measure
* Not affiliated to a social security system
* Refusal to participate. In the case of consent given for the born and unborn child, the consent must be given by the person(s) with parental authority.
* Live at a distance from the recruitment center incompatible with follow-up.

Specific non-inclusion criteria for the Low risk cohort:

Mother and/or father of unborn child:

\- Have a biological child with a diagnosis of Autism Spectrum Disorder or other neuro developmental disorder

Where it's running

• CHU Montpellier
  Montpellier, France Recruiting

Study contacts

• Study coordinator: Amaria Baghdadli, MD PhD
• Email: a-baghdadli@chu-montpellier.fr
• Phone: +33 4 67 33 63 83

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.