Child Development DisorderMALO_2NCT05215028
Optimization of Mother-child Dyad Follow-up by a Multidomain Application: Real-world Cross Sectional Study
An observational study of Child Development Disorder and Post Partum Depression, run by Weprom at 1 site in France.
Trial summary
After birth, the mother-child dyad can be impacted by issues which are usually under-detected or detected at early stage. Among these issues, neurodevelopmental disorders (NDD) such as autism spectrum disorder are common and affect 1 in 59 children but are detected after 4 years of age although it could be detected… Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Child Development Disorder, Post Partum Depression
- What is being tested?
- web-application
- Type of treatment
- Vaccines, Medical device
- How many people
- 4,346 participants
- Where
- 1 siteFrance
- Study dates
- 11 Nov 2021to 7 Jan 2022
- How long will I take part?
- 1 Day
- 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 3 years
- All sexes
- Child
Study population: The population includes all users of the Malo application, who did not object to the use of their data over the period from 11/11/2021 to 01/07/2022.
Who may be able to join
- Parent of child or more under 3 years of age
- User of application Malo
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.
About this study
After birth, the mother-child dyad can be impacted by issues which are usually under-detected or detected at early stage. Among these issues, neurodevelopmental disorders (NDD) such as autism spectrum disorder are common and affect 1 in 59 children but are detected after 4 years of age although it could be detected using parent report screens as early as 12 or 18 months of age. Moreover, parents are the main contributors of the screening of NDD in their children. In a recent French survey, the identification of the first symptoms was done by parents in 61% of cases and a health professional in only 14% and the mean age of disease detection was 6.8 years for autism spectrum disorder.
Other troubles that deserve early screening are hearing disorders which are observed in 1 child in 300 at 3 years of age and the main visual trouble in toddlers such as amblyopia which is observed with a prevalence of 3%.
Read more
Another issue that deserves improvement is the rate of mandatory or recommended vaccines in toddler which is only 71% for C-meningococcus and 79% for measles or rubella.
Concerning the mother, postnatal depression is defined as an episode of minor or major depression occurring during the first year postpartum with a pooled prevalence of 17.7%. Despite the high prevalence of this disorder and its potential impact on child development it remains underdetected and undertreated in daily practice.
The common point between all these disorders is that they can benefit from early detection by questionnaires intended for parents for their children or for themselves, because early treatment improves prognosis or prevent diseases.
An "all-in-one" multi-domain familial digital health record Patient reported outcomes application has been developing to help for early screening of neurodevelopmental disorders of toddler after birth to 3 years of age and mother's postnatal depression, to improve vaccinations rate of toddlers and to provide advice to parents for child development. The aim of the study is to assess in a real-world data-based the performances of this application.
- Conditions
- Child Development Disorder, Post Partum Depression
- Being tested
- web-application
- Medical subject headings
- Developmental Disabilities, Depression, Postpartum
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 multi-domain familial digital health record PRO The aim is to help for early screening of neurodevelopmental disorders of toddler after birth to 3 years of age and mother's postnatal depression, to improve vaccinations rate of toddlers and to provide advice to parents for child development.
| Study group | Role | What they receive |
|---|---|---|
| users | users of the web-application MALO Receives: Device: web-application |
What is being measured
The primary outcome is the main question the study is designed to answer.
impact on neurodevelopmental disorders detection
description of the rate and age at detection of each type of neurodevelopmental desorder
Measured: 3 years
impact on hearing disorders
description of the rate and age at detection
Measured: 3 years
impact on visual disorders
description of the rate and age at detection
Measured: 3 years
impact on mandatory or recommended vaccines
rate of vaccines
Measured: 3 years
impact on postnatal depression
rate of women in post natal depression
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start11 Nov 2021
- Primary completion7 Jan 2022
- Study completion7 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Development DisorderStudies 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
- 4,346 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Collaborators
- Kelindi
- Responsible party
- Sponsor
- Investigators
- Fabrice DENIS, Pr, Principal investigator, ILC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215028
- Sponsor's protocol ID
- WP-2022-02
- Acronym
- MALO_2
- Status last verified
- Jan 2022
- First submitted
- 18 Jan 2022
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Mother-child Dyad Follow-up by a Multidomain Application: Real-world Cross Sectional Study
- ClinicalTrials.gov ID
- NCT05215028
- Acronym / sponsor ID
- MALO_2 / WP-2022-02
- Conditions
- Child Development Disorder, Post Partum Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,346 participants (actual)
- Lead sponsor
- WepromUniversity, hospital or other
- Collaborators
- Kelindi
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 7 Jan 2022 (actual)
- Study completion
- 7 Jan 2022 (actual)
- First posted
- 31 Jan 2022 (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.
After birth, the mother-child dyad can be impacted by issues which are usually under-detected or detected at early stage. Among these issues, neurodevelopmental disorders (NDD) such as autism spectrum disorder are common and affect 1 in 59 children but are detected after 4 years of age although it could be detected using parent report screens as early as 12 or 18 months of age. Moreover, parents are the main contributors of the screening of NDD in their children. In a recent French survey, the identification of the first symptoms was done by parents in 61% of cases and a health professional in only 14% and the mean age of disease detection was 6.8 years for autism spectrum disorder.
Other troubles that deserve early screening are hearing disorders which are observed in 1 child in 300 at 3 years of age and the main visual trouble in toddlers such as amblyopia which is observed with a prevalence of 3%.
Another issue that deserves improvement is the rate of mandatory or recommended vaccines in toddler which is only 71% for C-meningococcus and 79% for measles or rubella.
Concerning the mother, postnatal depression is defined as an episode of minor or major depression occurring during the first year postpartum with a pooled prevalence of 17.7%. Despite the high prevalence of this disorder and its potential impact on child development it remains underdetected and undertreated in daily practice.
The common point between all these disorders is that they can benefit from early detection by questionnaires intended for parents for their children or for themselves, because early treatment improves prognosis or prevent diseases.
An "all-in-one" multi-domain familial digital health record Patient reported outcomes application has been developing to help for early screening of neurodevelopmental disorders of toddler after birth to 3 years of age and mother's postnatal depression, to improve vaccinations rate of toddlers and to provide advice to parents for child development. The aim of the study is to assess in a real-world data-based the performances of this application.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| users | – | Device: web-applicationusers of the web-application MALO |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Age groups
- Child
- Study population
- The population includes all users of the Malo application, who did not object to the use of their data over the period from 11/11/2021 to 01/07/2022.
Key inclusion criteria (2 listed)
- Parent of child or more under 3 years of age
- User of application Malo
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 multi-domain familial digital health record PRO The aim is to help for early screening of neurodevelopmental disorders of toddler after birth to 3 years of age and mother's postnatal depression, to improve vaccinations rate of toddlers and to provide advice to parents for child development. | Device | users |
Primary outcome
impact on neurodevelopmental disorders detection
Time frame: 3 years
description of the rate and age at detection of each type of neurodevelopmental desorder
impact on hearing disorders
Time frame: 3 years
description of the rate and age at detection
impact on visual disorders
Time frame: 3 years
description of the rate and age at detection
impact on mandatory or recommended vaccines
Time frame: 3 years
rate of vaccines
impact on postnatal depression
Time frame: 3 years
rate of women in post natal depression
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 31 Jan 2022.
- 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 principal investigator
ILC
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 Child Development Disorder and Post Partum 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 2 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 31 Jan 2022. 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?
impact on neurodevelopmental disorders detection (time frame: 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2022.