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Completed

NCT Number: NCT06301087

Early Detection 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

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Key information

Conditions

Development, Child Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Neurodevelopmental Disorders Postnatal Depression Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ILC

Le Mans, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web Application

Device

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

Other names: MALO

Primary outcomes

  1. Time to neurodevelopment desorder diagnostic

    Time frame: 20 months

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

Secondary outcomes

  1. User's satisfaction

    Time frame: 20 months

    Home made qualitatif satisfaction questionnaire

  2. Relevance of the neurodevelopmental desorder notification

    Time frame: 20 months

    Parent's feedback for physician's opinion after notification

  3. Rate of mothers'postnal depression

    Time frame: 20 months

    Number of mothers with grade 2 ou 3 at adapted Edimbourg postnatal depression scale

  4. 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)

Sponsors and collaborators

Lead sponsor

Weprom

Other

Collaborators

  • Kelindi

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2024
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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