Development, ChildNCT06301087
Early Detection Neurodevelopmental Disorders of Children and Prevention of Postnatal Depression by Mobile Health App
An observational study of Development, Child and Postnatal Depression, run by Weprom at 1 site in France.
Trial summary
The goal of this observational study is to confirm the impact of using this app adapted to be more specific for screening for 5 neurodevelopmental disorders and to evaluate the mothers' support program on the incidence of postpartum depression in of young parents with a minimum of 1 child under 10 years of age at the… Read more about this study
- Who is it for?
- Ages Up to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Development, Child, Postnatal Depression
- What is being tested?
- Web Application
- Type of treatment
- Medical device
- How many people
- 55,618 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2022to 8 Feb 2024
- 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 Up to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The population will include the first 50,000 users of the application who consent to the use of their data for this assessment young parent withe a minimum of 1 child under 10 years matching the criteria and agreeing to participate
Who may be able to join
- Youg parent with a minimum of 1 child under 10 years
- User of the app (downloaded)
- Having given informed consent (in-app)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Cross-Sectional Study of Early Detection of 5 Neurodevelopmental Disorders of Children and Prevention of Postnatal Depression by Mobile Health App
The goal of this observational study is to confirm the impact of using this app adapted to be more specific for screening for 5 neurodevelopmental disorders and to evaluate the mothers' support program on the incidence of postpartum depression in of young parents with a minimum of 1 child under 10 years of age at the time of inclusion and using Malo on a regular basis. The main questions it aims to answer are :
- the median age of possible neurodevelopmental disorders notification of infants
- the median time of the mothers' postnatal depression notifications after childbirth subsequently to the support and prevention program Participants will agree with use of their data
- Conditions
- Development, Child, Postnatal Depression
- Being tested
- Web Application
- Keywords
- early detection, neurodevelopmental disorders, postnatal depression, mHealth, real-world study, smartphone
- Medical subject headings
- Depression, Postpartum, Neurodevelopmental Disorders
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 and postnatal depression of mothers
| 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.
Time to neurodevelopment desorder diagnostic
Number of days between birth and notification of possible neurodevelopment desorder notification
Measured: 20 months
Secondary outcomes (4)
User's satisfaction
Home made qualitatif satisfaction questionnaire
Measured: 20 months
Relevance of the neurodevelopmental desorder notification
Parent's feedback for physician's opinion after notification
Measured: 20 months
Rate of mothers'postnal depression
Number of mothers with grade 2 ou 3 at adapted Edimbourg postnatal depression scale
Measured: 20 months
Time of mothers'postnatal depression
Number of days between Edimbourg postnatal depression scale grade 2 or 3 and childbirth (score 0 to 30 a higher score indicates a worse condition)
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 May 2022
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
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
- Cross-sectional
- Enrolment
- 55,618 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Collaborators
- Kelindi
- Responsible party
- Sponsor
- Investigators
- Fabrice DENIS, Principal investigator, Kelindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301087
- Sponsor's protocol ID
- WP-2024-01
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Denis F, Le Goff F, Desbois M, Gepner A, Feliciano G, Silber D, Zeitoun JD, Assuied GP. Early Detection of 5 Neurodevelopmental Disorders of Children and Prevention of Postnatal Depression With a Mobile Health App: Observational Cross-Sectional Study. JMIR Public Health Surveill. 2024 Jun 18;10:e58565. doi: 10.2196/58565.
PubMed 38888952
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cross-Sectional Study of Early Detection of 5 Neurodevelopmental Disorders of Children and Prevention of Postnatal Depression by Mobile Health App
- ClinicalTrials.gov ID
- NCT06301087
- Acronym / sponsor ID
- WP-2024-01
- Conditions
- Development, Child, Postnatal Depression
- Keywords
- early detection, neurodevelopmental disorders, postnatal depression, mHealth, real-world study, smartphone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55,618 participants (actual)
- Lead sponsor
- WepromUniversity, hospital or other
- Collaborators
- Kelindi
- Study start
- 1 May 2022 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 8 Mar 2024 (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 goal of this observational study is to confirm the impact of using this app adapted to be more specific for screening for 5 neurodevelopmental disorders and to evaluate the mothers' support program on the incidence of postpartum depression in of young parents with a minimum of 1 child under 10 years of age at the time of inclusion and using Malo on a regular basis. The main questions it aims to answer are :
- the median age of possible neurodevelopmental disorders notification of infants
- the median time of the mothers' postnatal depression notifications after childbirth subsequently to the support and prevention program Participants will agree with use of their data
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| users | – | Device: Web Applicationusers of the web-application |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The population will include the first 50,000 users of the application who consent to the use of their data for this assessment young parent withe a minimum of 1 child under 10 years matching the criteria and agreeing to participate
Key inclusion criteria (3 listed)
- Youg parent with a minimum of 1 child under 10 years
- User of the app (downloaded)
- Having given informed consent (in-app)
Key exclusion criteria (1 listed)
- none
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 and postnatal depression of mothers | Device | users |
Primary outcome
Time to neurodevelopment desorder diagnostic
Time frame: 20 months
Number of days between birth and notification of possible neurodevelopment desorder notification
4 secondary outcomes
User's satisfaction
Time frame: 20 months
Relevance of the neurodevelopmental desorder notification
Time frame: 20 months
Rate of mothers'postnal depression
Time frame: 20 months
Time of mothers'postnatal depression
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 38888952Denis F, Le Goff F, Desbois M, Gepner A, Feliciano G, Silber D, Zeitoun JD, Assuied GP. Early Detection of 5 Neurodevelopmental Disorders of Children and Prevention of Postnatal Depression With a Mobile Health App: Observational Cross-Sectional Study. JMIR Public Health Surveill. 2024 Jun 18;10:e58565. doi: 10.2196/58565.
- 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 principal investigator
Kelindi
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 and Postnatal Depression, 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 3 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: finished, as of the sponsor's last update on 15 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to neurodevelopment desorder diagnostic (time frame: 20 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 NCT06301087, 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 15 Mar 2024.