Optimization of Mother-child Dyad Follow-up by a Multidomain Application: Real-world Cross Sectional Study (MALO_2)

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.

Study Overview

• Status: Completed
• Conditions: Post Partum Depression; Child Development Disorder
• Intervention / Treatment: Device: web-application

• Study Type: Observational
• Enrollment (Actual): 4346

Contacts and Locations

Study Locations

• France
  • Le Mans, France, 72000
    • ILC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
users; users of the web-application MALO	Device: web-application; 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.; Other Names: MALO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Weprom
• Collaborators: Kelindi
• Investigators: Principal Investigator: Fabrice DENIS, Pr, ILC

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): January 7, 2022
• Study Completion (Actual): January 7, 2022

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Neurodevelopmental Disorders; Depressive Disorder; Depression, Postpartum; Developmental Disabilities
• Other Study ID Numbers: WP-2022-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No