A Smartphone Application for Screening of Developmental Disorders in Children

NCT04958174 | Unknown

• 1 other identifier: WP-2021-02
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Development, Child

Outcome Measures

Primary Outcomes (1)

• usefulness

  number of users who find the application useful

  6 months

Secondary Outcomes (3)

• Alert

  6 months

• Consultation

  6 months

• postpartum depression

  6 months

Study Arms (1)

Users

Users of the web-application

Device: web-application

Interventions

web-application DEVICE

web application for monitoring children's development

Also known as: MALO

Users

Eligibility Criteria

• Age: 1 Month - 3 Years
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Weprom: lead
• Kelindi: collaborator

Study Sites (1)

ILC

Le Mans, 72000, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 35576565 DERIVED

Study Officials

• Fabrice DENIS, Pr

  Weprom

  STUDY DIRECTOR

Central Study Contacts

Magali BALAVOINE

CONTACT

241682940; m.balavoine@ilcgroupe.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 12, 2021
• Study Start: August 15, 2021
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: December 20, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)