A Smartphone Application for Screening of Developmental Disorders in Children

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

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.

Study Overview

• Status: Recruiting
• Conditions: Development, Child
• Intervention / Treatment: Device: web-application

• Study Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

Study Locations

• France
  • Le Mans, France, 72000
    • Recruiting
    • ILC
    • Principal Investigator: Fabrice DENIS, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The application will be made available to Sarthois after a launch campaign by local media for parents with children aged 1 month to 3 years. The population will include the first 180 users of the application who did not object to the use of their data for this assessment.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Users; Users of the web-application	Device: web-application; web application for monitoring children's development; Other Names: MALO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
usefulness	number of users who find the application useful	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Weprom
• Collaborators: Kelindi
• Investigators: Study Director: Fabrice DENIS, Pr, Weprom

Publications and helpful links

General Publications

• Denis F, Maurier L, Carillo K, Ologeanu-Taddei R, Septans AL, Gepner A, Le Goff F, Desbois M, Demurger B, Silber D, Zeitoun JD, Assuied GP, Bonnot O. Early Detection of Neurodevelopmental Disorders of Toddlers and Postnatal Depression by Mobile Health App: Observational Cross-sectional Study. JMIR Mhealth Uhealth. 2022 May 16;10(5):e38181. doi: 10.2196/38181.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Anticipated): February 15, 2023
• Study Completion (Anticipated): February 15, 2023

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): December 20, 2021
• Last Update Submitted That Met QC Criteria: December 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Developmental Disabilities
• Other Study ID Numbers: WP-2021-02

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