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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Development, Child
• Neurodevelopmental Disorders
• Postnatal Depression

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