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NCT04958174 Clinical Trial

A Smartphone Application for Screening of Developmental Disorders in Children

Development, Child Clinical Trial

Official title:
A Smartphone Application for Screening of Developmental Disorders in Children: a Prospective Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04958174
Other study ID # WP-2021-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 15, 2021
Est. completion date February 15, 2023

Study information
Verified date June 2021
Source Weprom
Contact Magali BALAVOINE
Phone 241682940
Email m.balavoine@ilcgroupe.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date February 15, 2023
Est. primary completion date February 15, 2023
Accepts healthy volunteers
Gender All
Age group 1 Month to 3 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• web-application
web application for monitoring children's development

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 usefulness number of users who find the application useful 6 months
Secondary Alert Description of alerts triggered by algorithms 6 months
Secondary Consultation Number of relevant consultations (or teleconsultations) after an alert 6 months
Secondary postpartum depression Number of women in postpartum depression 6 months
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