Attention DeficitMEDiATE-PRVNCT04831762
Markers of Executive Attention Development in Preschoolers - Behavioral Measures in Various Populations
An observational study of Attention Deficit, run by University Hospital, Caen at 1 site in France.
Trial summary
Executive attention is essential for emotional and behavioral self-regulation. There is inter-individual variability in the level of efficiency of executive attention from kindergarten entry, and this variability predicts children's academic performance at entry to elementary school and beyond. Read more about this study
- Who is it for?
- Ages 48 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit
- What is being tested?
- Attention Network task (computerized), Head-toes-knees-schoulders and Laby 5-12
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 31 Dec 2023
- 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 48 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preschoolers 48 to 71 months of age.
Who may be able to join
- Attending preschool
- Parental informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Comete U1075 Inserm Unicaen
Caen, 14032
Nadege Roche-Labarbe, PhD
About this study
Official title: MARQUEURS DE DEVELOPPEMENT DE L'ATTENTION EXECUTIVE CHEZ L'ENFANT : POPULATIONS VARIEES
Executive attention is essential for emotional and behavioral self-regulation. There is inter-individual variability in the level of efficiency of executive attention from kindergarten entry, and this variability predicts children's academic performance at entry to elementary school and beyond. It is therefore essential to better understand the early stages of executive attention development and self-regulation from an early age in order to develop tools for early detection of executive attention disorders, so that school accommodations can be proposed as early as possible.
In previous work, we have identified early tactile information processing skills that underpin the development of executive attention. We would like to extend this work to a diverse population of preschool children, in order to consider new tools for the early detection of attention disorders. The MEDiATE-PRV project aims to compare the performance obtained in a validated attentional task in preschool children with assessments of tactile information processing, in relation to the psychomotor and executive development of the child. We will include 200 children aged 4 years to 5 years 11 months with different risk factors for ADHD.
- Conditions
- Attention Deficit
- Being tested
- Attention Network task (computerized), Head-toes-knees-schoulders, Laby 5-12, M-ABC 2, Stroop animals
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Network task (computerized)Behavioural
Also called Child ANT, flankers task
Computer-based game challenging orienting and executive attention. The subject must chose which side an animal is going, using left and right buttons, depending on the validity of a cue and the congruency of flankers.
Head-toes-knees-schouldersBehavioural
Also called HTKS
Following motor commands such as touch your head when they are congruent or incongruent.
Laby 5-12Behavioural
Test of motor planning using labyrinths
M-ABC 2Behavioural
Test of motor functions using various subtests of gross and fine motor function.
Stroop animalsBehavioural
Stroop test for preK children using animals instead of words
What is being measured
The primary outcome is the main question the study is designed to answer.
ANT performance
Reaction time in ms to ANT trials with a correct answer
Measured: 48 to 71 months of age
Tactile processing score
Score to the sensory profile tactile subtest
Measured: 48 to 71 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Mar 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention DeficitStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831762
- Sponsor's protocol ID
- 2020-A03209-30
- Acronym
- MEDiATE-PRV
- Status last verified
- Mar 2022
- First submitted
- 2 Apr 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MARQUEURS DE DEVELOPPEMENT DE L'ATTENTION EXECUTIVE CHEZ L'ENFANT : POPULATIONS VARIEES
- ClinicalTrials.gov ID
- NCT04831762
- Acronym / sponsor ID
- MEDiATE-PRV / 2020-A03209-30
- Conditions
- Attention Deficit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Apr 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.
Executive attention is essential for emotional and behavioral self-regulation. There is inter-individual variability in the level of efficiency of executive attention from kindergarten entry, and this variability predicts children's academic performance at entry to elementary school and beyond. It is therefore essential to better understand the early stages of executive attention development and self-regulation from an early age in order to develop tools for early detection of executive attention disorders, so that school accommodations can be proposed as early as possible.
In previous work, we have identified early tactile information processing skills that underpin the development of executive attention. We would like to extend this work to a diverse population of preschool children, in order to consider new tools for the early detection of attention disorders. The MEDiATE-PRV project aims to compare the performance obtained in a validated attentional task in preschool children with assessments of tactile information processing, in relation to the psychomotor and executive development of the child. We will include 200 children aged 4 years to 5 years 11 months with different risk factors for ADHD.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 48 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preschoolers 48 to 71 months of age.
Key inclusion criteria (2 listed)
- Attending preschool
- Parental informed consent
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 |
|---|---|---|
| Attention Network task (computerized)Also: Child ANT, flankers taskComputer-based game challenging orienting and executive attention. The subject must chose which side an animal is going, using left and right buttons, depending on the validity of a cue and the congruency of flankers. | Behavioural | – |
| Head-toes-knees-schouldersAlso: HTKSFollowing motor commands such as touch your head when they are congruent or incongruent. | Behavioural | – |
| Laby 5-12Test of motor planning using labyrinths | Behavioural | – |
| M-ABC 2Test of motor functions using various subtests of gross and fine motor function. | Behavioural | – |
| Stroop animalsStroop test for preK children using animals instead of words | Behavioural | – |
Primary outcome
ANT performance
Time frame: 48 to 71 months of age
Reaction time in ms to ANT trials with a correct answer
Tactile processing score
Time frame: 48 to 71 months of age
Score to the sensory profile tactile subtest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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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.
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 Attention Deficit, run by University Hospital, Caen 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: status not confirmed, as of the sponsor's last update on 9 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadege Roche-Labarbe, PhD (+33(0)649922568, nadege.roche@unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ANT performance (time frame: 48 to 71 months of age). The study lists 2 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 9 Mar 2022.