Platform for the Prospective Mother-child Study of the Determinants of Neurodevelopmental Disorders
MARIANNE
1 other identifier
observational
6,300
1 country
1
Brief Summary
Neurodevelopmental disorders such as attention deficit disorder with or without hyperactivity, autism spectrum disorder, language and social communication disorder, motor coordination disorder, learning disorder (dyslexia, dyscalculia, dysorthography), intellectual development disorder are frequent and long-lasting developmental difficulties that can be observed in children in various domains. They are often associated and have a significant impact on daily functioning at school and at home. The rate of people affected by neurodevelopmental disorders including autism spectrum disorder have increased significantly over the past 20 years. Improved screening only partly explains this evolution. A genetic predisposition plays an important role in the occurrence of these disorders, however, current scientific data suggest a multifactorial origin. Exposures such as those related to the use of pesticides, air pollution or the presence of endocrine disruptors in our diet could be involved in the genesis of neurodevelopmental disorders, particularly during intrauterine life, a period of great vulnerability. The current diagnostic pathways for autism rarely enable the early identification of babies at risk. Without early detection and timely targeted intervention, these children have a poor health outcome and do not reach their full potential. The general objective of the MARIANNE cohort is to constitute a French research infrastructure dedicated to research on the biological and environmental determinants of neurodevelopmental disorders including autism. This cohort is based on the follow-up of 1200 families with already a child affected by an autism spectrum disorder, which implies a high risk of neurodevelopmental disorders including autism spectrum disorder for the siblings, and of 500 families from the general population with no excess risk of neurodevelopmental disorders. The total number of subjects to be included (mother, father, unborn child and ASD sibling for the HR group) is thus 6300. The inclusion of these families will be at the beginning of a new pregnancy and the follow-up will be carried out from the second trimester of pregnancy until the children are 6 years old, the age at which the diagnosis of neurodevelopmental disorders is possible. Biological, clinical, social and environmental data will be collected at different stages of the follow-up and will be included into a large database.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2023
CompletedFirst Posted
Study publicly available on registry
January 12, 2023
CompletedStudy Start
First participant enrolled
April 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2034
January 16, 2025
January 1, 2025
10.9 years
January 3, 2023
January 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Autism Spectrum Disorder diagnosis
ASD diagnosis will be determined by the ADOS-2 (Autism Diagnostic Observation Schedule)
between 60 and 66 months
Autism Spectrum Disorder diagnosis
ASD diagnosis will be determined by the ADOS-2 (Autism Diagnostic Observation
between 24 and 30 months
Developmental Intelligence Disorder diagnosis
Measure of intelligence quotient by scales adapted to the child's age and level of development and developmental level: Weschler, or Mullen scales
at 72 months
Developmental Coordination Disorder diagnosis
Description: the diagnosis will be determined by the DCDQ-FE (Developmental Coordination Disorder Parent Questionnaire Coordination), a 15 items scale, which is the French-European version of the DCDQ-0, Developmental Coordination Disorder Parent Questionnaire Coordination to help identify Developmental Coordination Disorder in children aged 5 to 15 years. The items are grouped into three subdomains: 1) control during movement, 2) fine motor/writing, and 3) global coordination. Each item is rated on a 5-point scale, from 1 ("does not match my child at all") to 5 ("matches my child perfectly")."
at 72 months
Attention Deficit Hyperactivity Disorder diagnosis
The diagnosis will be determined by ADHD-RS, which is a parent questionnaire for the assessment of Attention Deficit Hyperactivity Disorder (ADHD). The items are rated on a 4-point scale (from 0= rarely or never, to 3= very often). A score greater than or equal to 28 is required to qualify as significant ADHD with this scale.
at 72 months
Diagnosis of Language and Learning Disorder
the diagnosis will be determined with the Parents' Evaluation of developmental status (PEDS: DM), which targets the concerns of parents of children aged 0 to 8 years in 8 domains (gross and fine motor skills and writing and mathematics; social/emotional; oral/written language and reading; adaptive behavior). This questionnaire has been validated in several countries and covers several domains, each with 6 to 8 questions and 3 answer choices. The results are evaluated as normal/delayed "Are you worried about your child's development? Yes/No" with details of the reasons, the age of onset and a question on the wish to have an interview with a psychologist or a child psychiatrist.
at 72 months
Socioeconomic and lifestyle risk factors for neurodevelopmental disorders including autism spectrum disorder
Parental self-questionnaire
at inclusion
Maternal diet and medication use during pregnancy
Parental self-questionnaire
at inclusion
Environmental exposition
Parental self-questionnaire. A biological collection is realized for the realization of future assays
at inclusion
Study Arms (2)
High-Risk Cohort
High family risk cohort for recurrence of autism and other developmental disorders in siblings (have at least one child with a confirmed diagnosis of autism) Specific to the High Risk cohort: Clinical observations of the unborn child will be performed at 3 months, 6 months, 12 months, between 24 and 30 months, 36 months, and 72 months by psychologists or child psychiatrists in the participating hospitals. They will allow to evaluate the child's behaviors in the areas of communication and social interaction. A video recording of the baby at 3 months of age will allow the analysis of the General Movements Assessment. If genetic consultation is provided to the family as part of the routine care, the results will be collected and additional blood samples may be taken
Low Risk Cohort
Low family risk cohort for recurrence of autism and occurrence of other developmental disorders in siblings. The risk is comparable to the risk observed in the general population (do not have a child with autism, nor with other developmental disorders). Clinical observations of the unborn child will be performed at 72 months by psychologists or child psychiatrists in the participating hospitals, so that children in the "Low family risk" group benefit from the same evaluations as children in the "High family risk" group..
Interventions
Parents will be asked to complete online self-questionnaires. These questionnaires will provide essential information on medical data, child development, lifestyle habits, nutritional habits, environmental exposures, and family social characteristics.
urine, hair, nails, baby tooth, stool, blood, umbilical cord blood, placenta
High-Risk Cohort : Clinical observations of the unborn child will be performed at 3 months, 6 months, 12 months, between 24 and 30 months, 36 months, and 72 months by psychologists or child psychiatrists in the participating hospitals. They will allow to evaluate the child's behaviors in the areas of communication and social interaction. A video recording of the baby at 3 months of age will allow the analysis of the General Movements Assessment. Low-Risk Cohort : linical observations of the unborn child will be performed at 72 months by psychologists or child psychiatrists in the participating hospitals.
If genetic consultation is provided to the family as part of the routine care, the results will be collected and additional blood samples may be taken.
Eligibility Criteria
Low risk cohort is a community based sample. High risk cohort is a community based sample as well as an active list of patients followed in specialized department in the management of children with neurodevelopmental disorders. The persons involved in the study are the pregnant woman, her partner (if he is the biological father of the unborn child and lives with the mother), the newborn child, and the older sibling with autism.
You may qualify if:
- 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.
- 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.
- +1 more criteria
You may not qualify if:
- 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.
- Mother and/or father of unborn child:
- \- Have a biological child with a diagnosis of Autism Spectrum Disorder or other neuro developmental disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Montpellierlead
- University Hospital, Lillecollaborator
- Hospices Civils de Lyoncollaborator
- University Hospital of Saint-Etiennecollaborator
- University Hospital, Rouencollaborator
- University Hospital, Toulousecollaborator
- Hôpital le Vinatiercollaborator
Study Sites (1)
CHU Montpellier
Montpellier, 34 090, France
Biospecimen
urine, hair, nails, baby tooth, stool, blood, umbilical cord blood, placenta
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2023
First Posted
January 12, 2023
Study Start
April 19, 2023
Primary Completion (Estimated)
March 1, 2034
Study Completion (Estimated)
March 1, 2034
Last Updated
January 16, 2025
Record last verified: 2025-01