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

March 13, 2024 updated by: Weprom

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

55618

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
users
users of the web-application
Device: Web Application
web application for monitoring children's development and postnatal depression of mothers
Other Names:
  • MALO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to neurodevelopment desorder diagnostic
Time Frame: 20 months
Number of days between birth and notification of possible neurodevelopment desorder notification
20 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
User's satisfaction
Time Frame: 20 months
Home made qualitatif satisfaction questionnaire
20 months
Relevance of the neurodevelopmental desorder notification
Time Frame: 20 months
Parent's feedback for physician's opinion after notification
20 months
Rate of mothers'postnal depression
Time Frame: 20 months
Number of mothers with grade 2 ou 3 at adapted Edimbourg postnatal depression scale
20 months
Time of mothers'postnatal depression
Time Frame: 7 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weprom

Collaborators

Kelindi

Investigators

  • Principal Investigator: Fabrice DENIS, Kelindi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

February 8, 2024

Study Completion (Actual)

February 8, 2024

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WP-2024-01

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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