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NCT06301087 Clinical Trial

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

Development, Child Clinical Trial

Official title:
An Observational Cross-Sectional Study of Early Detection of 5 Neurodevelopmental Disorders of Children and Prevention of Postnatal Depression by Mobile Health App

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06301087
Other study ID # WP-2024-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date February 8, 2024

Study information
Verified date March 2024
Source Weprom
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 55618
Est. completion date February 8, 2024
Est. primary completion date February 8, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 10 Years
Eligibility Inclusion Criteria: - Youg parent with a minimum of 1 child under 10 years - User of the app (downloaded) - Having given informed consent (in-app) Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Web Application
web application for monitoring children's development and postnatal depression of mothers

Locations
Country Name City State
France ILC Le Mans

Sponsors (2)
Lead Sponsor Collaborator
Weprom Kelindi

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to neurodevelopment desorder diagnostic Number of days between birth and notification of possible neurodevelopment desorder notification 20 months
Secondary User's satisfaction Home made qualitatif satisfaction questionnaire 20 months
Secondary Relevance of the neurodevelopmental desorder notification Parent's feedback for physician's opinion after notification 20 months
Secondary Rate of mothers'postnal depression Number of mothers with grade 2 ou 3 at adapted Edimbourg postnatal depression scale 20 months
Secondary Time of mothers'postnatal depression Number of days between Edimbourg postnatal depression scale grade 2 or 3 and childbirth (score 0 to 30 a higher score indicates a worse condition) 7 months
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