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A Smartphone Application for Screening of Developmental Disorders in Children

NCT ID: NCT04958174

Last Updated: 2021-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-15

Study Completion Date

2023-02-15

Brief Summary

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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

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Conditions

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Development, Child

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Users

Users of the web-application

web-application

Intervention Type DEVICE

web application for monitoring children's development

Interventions

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web-application

web application for monitoring children's development

Intervention Type DEVICE

Other Intervention Names

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MALO

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kelindi

INDUSTRY

Sponsor Role collaborator

Weprom

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabrice DENIS, Pr

Role: STUDY_DIRECTOR

Weprom

Locations

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ILC

Le Mans, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Magali BALAVOINE

Role: CONTACT

Phone: 241682940

Email: [email protected]

Facility Contacts

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Fabrice DENIS, Pr

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35576565 (View on PubMed)

Other Identifiers

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WP-2021-02

Identifier Type: -

Identifier Source: org_study_id