Early Detection Neurodevelopmental Disorders of Children and Prevention of Postnatal Depression by Mobile Health App

NCT06301087 | Completed

• 1 other identifier: WP-2024-01
• Study Type: observational
• Target: 55,618
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to confirm the impact of using this app adapted to be more specific for screening for 5 neurodevelopmental disorders and to evaluate the mothers' support program on the incidence of postpartum depression in of young parents with a minimum of 1 child under 10 years of age at the time of inclusion and using Malo on a regular basis. The main questions it aims to answer are :

• the median age of possible neurodevelopmental disorders notification of infants
• the median time of the mothers' postnatal depression notifications after childbirth subsequently to the support and prevention program Participants will agree with use of their data

Conditions

Development, Child; Postnatal Depression

Keywords

early detection; neurodevelopmental disorders; postnatal depression; mHealth; real-world study; smartphone

Outcome Measures

Primary Outcomes (1)

• Time to neurodevelopment desorder diagnostic

  Number of days between birth and notification of possible neurodevelopment desorder notification

  20 months

Secondary Outcomes (4)

• User's satisfaction

  20 months

• Relevance of the neurodevelopmental desorder notification

  20 months

• Rate of mothers'postnal depression

  20 months

• Time of mothers'postnatal depression

  7 months

Study Arms (1)

users

users of the web-application

Device: Web Application

Interventions

Web Application DEVICE

web application for monitoring children's development and postnatal depression of mothers

Also known as: MALO

users

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The population will include the first 50,000 users of the application who consent to the use of their data for this assessment young parent withe a minimum of 1 child under 10 years matching the criteria and agreeing to participate

You may qualify if:

• Youg parent with a minimum of 1 child under 10 years
• User of the app (downloaded)
• Having given informed consent (in-app)

You may not qualify if:

• none

Sponsors & Collaborators

• Weprom: lead
• Kelindi: collaborator

Study Sites (1)

ILC

Le Mans, France

Location

Related Publications (1)

• Denis F, Le Goff F, Desbois M, Gepner A, Feliciano G, Silber D, Zeitoun JD, Assuied GP. Early Detection of 5 Neurodevelopmental Disorders of Children and Prevention of Postnatal Depression With a Mobile Health App: Observational Cross-Sectional Study. JMIR Public Health Surveill. 2024 Jun 18;10:e58565. doi: 10.2196/58565.

  PMID: 38888952 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Fabrice DENIS

  Kelindi

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 8, 2024
• Study Start: May 1, 2022
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)