Development, ChildNCT04958174
A Smartphone Application for Screening of Developmental Disorders in Children
An observational study of Development, Child, run by Weprom at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 1 month to 3 years
- Conditions the study is for
- Development, Child
- What is being tested?
- web-application
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 15 Aug 2021to 15 Feb 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 3 years
- All sexes
- Child
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.
Who may be able to join
- Parent of a child or more under 3 years of age (1 month to 3 years)
Who cannot join
- Parent of a child who has already been diagnosed with a developmental disorder, known physical or mental disability
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
ILC
Le Mans, 72000
Fabrice DENIS, Pr, f.denis@ilcgroupe.fr
Fabrice DENIS, Pr
About this study
Official title: 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.
Read more
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
- Being tested
- web-application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-applicationDevice
Also called MALO
web application for monitoring children's development
| Study group | Role | What they receive |
|---|---|---|
| Users | Users of the web-application Receives: Device: web-application |
What is being measured
The primary outcome is the main question the study is designed to answer.
usefulness
number of users who find the application useful
Measured: 6 months
Secondary outcomes (3)
Alert
Description of alerts triggered by algorithms
Measured: 6 months
Consultation
Number of relevant consultations (or teleconsultations) after an alert
Measured: 6 months
postpartum depression
Number of women in postpartum depression
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start15 Aug 2021
- Primary completion15 Feb 2023 (estimated)
- Study completion15 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Development, ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Collaborators
- Kelindi
- Responsible party
- Sponsor
- Investigators
- Fabrice DENIS, Pr, Study director, Weprom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958174
- Sponsor's protocol ID
- WP-2021-02
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35576565
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smartphone Application for Screening of Developmental Disorders in Children: a Prospective Feasibility Study
- ClinicalTrials.gov ID
- NCT04958174
- Acronym / sponsor ID
- WP-2021-02
- Conditions
- Development, Child
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- WepromUniversity, hospital or other
- Collaborators
- Kelindi
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 15 Feb 2023 (estimated)
- Study completion
- 15 Feb 2023 (estimated)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Users | – | Device: web-applicationUsers of the web-application |
Who may qualify
- Ages
- 1 month to 3 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Parent of a child or more under 3 years of age (1 month to 3 years)
Key exclusion criteria (1 listed)
- Parent of a child who has already been diagnosed with a developmental disorder, known physical or mental disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web-applicationAlso: MALOweb application for monitoring children's development | Device | Users |
Primary outcome
usefulness
Time frame: 6 months
number of users who find the application useful
3 secondary outcomes
Alert
Time frame: 6 months
Consultation
Time frame: 6 months
postpartum depression
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Derived from this study: PubMed 35576565Denis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice DENIS, Pr study director
Weprom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Development, Child, run by Weprom at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magali BALAVOINE (241682940 ext. 0033, m.balavoine@ilcgroupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
usefulness (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04958174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.