Clinical trial NCT04958174: A Smartphone Application for Screening of Developmental Disorders in Children
Official title: A Smartphone Application for Screening of Developmental Disorders in Children: a Prospective Feasibility Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Development, Child
Lead sponsor: Weprom
Sponsor class: OTHER
Collaborators: name: Kelindi
First posted: 2021-07-12
Enrollment: 180
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: usefulness
timeFrame: 6 months
Secondary outcomes:
measure: Alert
timeFrame: 6 months
measure: Consultation
timeFrame: 6 months
measure: postpartum depression
timeFrame: 6 months
Other outcomes:
Locations:
city: Le Mans
country: France
facility: ILC
Study officials:
affiliation: Weprom
name: Fabrice DENIS, Pr
role: STUDY_DIRECTOR
References:
citation: 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.