A Smartphone Application for Screening of Developmental Disorders in Children

• Conditions: Development, Child
• Interventions: Device: web-application

• Registration Number: NCT04958174
• Lead Sponsor: Weprom

Brief Summary

The detection of developmental disorders in the child is often late because the parents do not have the information necessary to consult at the first clinical signs. For example, the diagnosis of autism spectrum disorders is made at the age of 5, so earlier diagnoses are possible earlier or even in the 1st year with appropriate questionnaires.

An application (Malo) has been developed to allow through regular questionnaires from 1 month to 3 years old to assess the child's development by his parents in the form of a digital health record assessing several areas at regular intervals (monthly the 1st year then every 3 to 12 months): sensory, psychomotor development, sleep, height and weight, cognitive and addictions (especially to screens). The questions will be adapted to the age of the child. An alert suggesting to consult the general practitioner or the pediatrician will be generated according to an algorithm validated by a committee of experts.

Based on a study model on health data already carried out as part of the triage application for patients suspected of COVID 19 coronavirus disease.fr with 14 million users in 6 months having improved the relevance of calls to the 15 (8 times fewer unnecessary calls) and general practitioners.

This study will assess parental interest in this application.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-06-29
• Study First Posted: 2021-07-12
• Study Start: 2021-08-15
• Last Update Submitted: 2021-12-03
• Last Update Posted: 2021-12-20
• Primary Completion: 2023-02-15
• Study Completion: 2023-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Parent of a child or more under 3 years of age (1 month to 3 years)

Exclusion Criteria

• Parent of a child who has already been diagnosed with a developmental disorder, known physical or mental disability

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Users	web-application	Users of the web-application

Primary Outcome Measures

Name	Time	Method
usefulness	6 months	number of users who find the application useful

Secondary Outcome Measures

Name	Time	Method
Alert	6 months	Description of alerts triggered by algorithms
postpartum depression	6 months	Number of women in postpartum depression
Consultation	6 months	Number of relevant consultations (or teleconsultations) after an alert

Trial Locations

Locations (1)

ILC; 🇫🇷 Le Mans, France