Optimization of Mother-child Dyad Follow-up by a Multidomain Application: Real-world Cross Sectional Study

NCT05215028 | Completed

• 1 other identifier: WP-2022-02
• Study Type: observational
• Target: 4,346
• Locations: 1 country
• Sites: 1

Brief Summary

After birth, the mother-child dyad can be impacted by issues which are usually under-detected or detected at early stage. Among these issues, neurodevelopmental disorders (NDD) such as autism spectrum disorder are common and affect 1 in 59 children but are detected after 4 years of age although it could be detected using parent report screens as early as 12 or 18 months of age. Moreover, parents are the main contributors of the screening of NDD in their children. In a recent French survey, the identification of the first symptoms was done by parents in 61% of cases and a health professional in only 14% and the mean age of disease detection was 6.8 years for autism spectrum disorder. Other troubles that deserve early screening are hearing disorders which are observed in 1 child in 300 at 3 years of age and the main visual trouble in toddlers such as amblyopia which is observed with a prevalence of 3%. Another issue that deserves improvement is the rate of mandatory or recommended vaccines in toddler which is only 71% for C-meningococcus and 79% for measles or rubella. Concerning the mother, postnatal depression is defined as an episode of minor or major depression occurring during the first year postpartum with a pooled prevalence of 17.7%. Despite the high prevalence of this disorder and its potential impact on child development it remains underdetected and undertreated in daily practice. The common point between all these disorders is that they can benefit from early detection by questionnaires intended for parents for their children or for themselves, because early treatment improves prognosis or prevent diseases. An "all-in-one" multi-domain familial digital health record Patient reported outcomes application has been developing to help for early screening of neurodevelopmental disorders of toddler after birth to 3 years of age and mother's postnatal depression, to improve vaccinations rate of toddlers and to provide advice to parents for child development. The aim of the study is to assess in a real-world data-based the performances of this application.

Conditions

Child Development Disorder; Post Partum Depression

Outcome Measures

Primary Outcomes (5)

• impact on neurodevelopmental disorders detection

  description of the rate and age at detection of each type of neurodevelopmental desorder

  3 years

• impact on hearing disorders

  description of the rate and age at detection

  3 years

• impact on visual disorders

  description of the rate and age at detection

  3 years

• impact on mandatory or recommended vaccines

  rate of vaccines

  3 years

• impact on postnatal depression

  rate of women in post natal depression

  3 years

Study Arms (1)

users

users of the web-application MALO

Device: web-application

Interventions

web-application DEVICE

web application multi-domain familial digital health record PRO The aim is to help for early screening of neurodevelopmental disorders of toddler after birth to 3 years of age and mother's postnatal depression, to improve vaccinations rate of toddlers and to provide advice to parents for child development.

Also known as: MALO

users

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The population includes all users of the Malo application, who did not object to the use of their data over the period from 11/11/2021 to 01/07/2022.

You may qualify if:

• Parent of child or more under 3 years of age
• User of application Malo

You may not qualify if:

• Parent of a child who has already been diagnosed with a developmental disorder, known physical or mental disability

Sponsors & Collaborators

• Weprom: lead
• Kelindi: collaborator

Study Sites (1)

ILC

Le Mans, 72000, France

Location

MeSH Terms

Conditions

Developmental Disabilities; Depression, Postpartum

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders

Study Officials

• Fabrice DENIS, Pr

  ILC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 31, 2022
• Study Start: November 11, 2021
• Primary Completion: January 7, 2022
• Study Completion: January 7, 2022
• Last Updated: January 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)