ADHDBio-PreTDAHNCT07440992
Identification of Early Biomarkers of Pre-school ADHD
An observational study of ADHD, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
ADHD affects around 5% of children and manifests itself as hyperactivity, attention difficulties and motor control and balance problems. The prevalence of ADHD is particularly high in certain populations, affecting up to 25-30% of children born prematurely and around 20% of children with neurological conditions such… Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2026to 1 Mar 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 30 children aged between 3 and 5 years and 11 months, with clinical criteria for ADHD, will be compared with 30 healthy children of the same age.
Who may be able to join
- For ADHD subjects:
- Children aged between 3.0 and 5 years and 11 months, with clinical criteria for ADHD, according to DSM 5.
- Children followed in the Child and Adolescent Psychiatry Department of Robert Debré Hospital.
- Children naïve to pharmacological treatment for ADHD
- For control subjects:
- Children between 3.0 - 5 years and 11 months
- No known condition or disease affecting development and behavior
Who cannot join
- For both groups
- Intellectual disability according to DSM 5 +- WPPSI IV < 70
- Refusal of the child or one of his parents or representatives of parental authority.
- Patient under AME or not affiliated to a social security scheme
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Robert Debré Hospital
Paris, 75019
Ana MOSCOSO, Dr., +33(0)140032295, ana.moscoso@aphp.fr
About this study
Official title: Identification of Early Biomarkers of Pre-school ADHD: Pilot Study for the Development of a Clinical and Research Platform Dedicated to Early Detection and Intervention
ADHD affects around 5% of children and manifests itself as hyperactivity, attention difficulties and motor control and balance problems. The prevalence of ADHD is particularly high in certain populations, affecting up to 25-30% of children born prematurely and around 20% of children with neurological conditions such as epilepsy. This disorder is officially diagnosed from the age of 6, according to current criteria. However, its clinical manifestations appear much earlier, having a significant impact on all aspects of the child's life, particularly in the most severe forms, which are often unrecognised due to a lack of clinical resources, and therefore without appropriate treatment.
The creation of a platform dedicated to children at risk of ADHD will enable specific clinical expertise to be developed, with the aim of proposing early targeted interventions and positively influencing the development of their trajectory. This platform will also aim to develop new diagnostic methods, based on indirect measures of attentional and executive processes, balance and the development of a risk measurement scale. This development is essential, as the assessment tools currently available lack specificity.
In order to demonstrate the reliability of the innovative diagnostic methods proposed, a comparative pilot study between children from the first clinical cohort (N=30) and a group of healthy children of the same age (N=30) will be carried out. This will enable us to study the discrimination of our tools and make any necessary adjustments. This pilot study also includes a longitudinal re-evaluation, at 12 months, of the children in the ADHD cohort, in order to study changes in these biomarkers over time.
Read the detailed description
ADHD and control patients will be informed of the study at least 1 week before the inclusion visit.
During the inclusion visit, after consent has been obtained from those with parental authority, patients in both groups will be :
- Review of inclusion and non-inclusion criteria
- Neuropsychological assessment: WPPSI-IV; K-CPT
- Self-questionnaires: ADHD-RS preschool version, temperament scale (CBQ)
- Experimental evaluation: Eye movement recording, vestibular examination, postural recording, VVS test Patients in the ADHD group will be reassessed at 12 months using the same procedure as the inclusion visit.
- Conditions
- ADHD
- Keywords
- Psychiatry, pediatry, ADHD
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patient | ADHD patients group: Assessement at V0 et V12 months Review of inclusion and non-inclusion criteria * Neuropsychological assessment: WPPSI-IV; K-CPT * Self-questionnaires: ADHD-RS preschool version, temperament scale (CBQ) * Experimental evaluation: Eye movement recording, vestibular examination, postural recording, VVS test | |
| Control | Control subjects group, with no know conditions or desease affecting development and behavior: assessement only at V0 Review of inclusion and non-inclusion criteria * Neuropsychological assessment: WPPSI-IV; K-CPT * Self-questionnaires: ADHD-RS preschool version, temperament scale (CBQ) * Experimental evaluation: Eye movement recording, vestibular examination, postural recording, VVS test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores obtained in eye tracking tests between the ADHD group and the control group (fixation duration)
Identification of biomarkers of visual attention by comparing scores obtained in eye-tracking tests between the ADHD group and the control group.
Measured: At baseline
Scores obtained in eye tracking tests between the ADHD group and the control group (latencies)
Identification of biomarkers of visual attention by comparing scores obtained in eye-tracking tests between the ADHD group and the control group
Measured: At baseline
Scores obtained in eye tracking tests between the ADHD group and the control group (number of errors)
Identification of biomarkers of visual attention by comparing scores obtained in eye-tracking tests between the ADHD group and the control group
Measured: At baseline
Secondary outcomes (5)
Scores obtained in vestibular tests in both groups and Progression at 12 months in the ADHD group (clinical exam)
Identifying biomarkers linked to vestibular function in ADHD children compared to controls
Measured: At baseline
Scores obtained in Subjective visual vertical test in both groups and Progression at 12 months in the ADHD group
Evaluate the diagnostic performance of the different biomarkers (visual and vestibular attention) in relation to the usual neuropsychological tests or self-questionnaires
Measured: At baseline & at 12 months
WPPSI (Wechsler Preschool and Primary Scale of Intelligence) sub-scores in both groups and Progression at 12 months in the ADHD group
Evaluate the diagnostic performance of the different biomarkers (visual and vestibular attention) in relation to the usual neuropsychological tests or self-questionnaires
Measured: At baseline & at 12 months
K-CPT (Conners Kiddie Continuous Performance) scores in both groups (impulsivity scores) and Progression at 12 months in the ADHD group
Evaluate the diagnostic performance of the different biomarkers (visual and vestibular attention) in relation to the usual neuropsychological tests or self-questionnaires
Measured: At baseline & at 12 months
Parent self-questionnaire scores in both groups and Progression at 12 months in the ADHD group
Evaluate the diagnostic performance of the different biomarkers (visual and vestibular attention) in relation to the usual neuropsychological tests or self-questionnaires
Measured: At baseline & at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440992
- Sponsor's protocol ID
- APHP251111
- Other IDs
- 2025-A01707-42
- Acronym
- Bio-PreTDAH
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Early Biomarkers of Pre-school ADHD: Pilot Study for the Development of a Clinical and Research Platform Dedicated to Early Detection and Intervention
- ClinicalTrials.gov ID
- NCT07440992
- Acronym / sponsor ID
- Bio-PreTDAH / APHP251111
- Conditions
- ADHD
- Keywords
- Psychiatry, pediatry, ADHD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 27 Feb 2026 (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.
ADHD affects around 5% of children and manifests itself as hyperactivity, attention difficulties and motor control and balance problems. The prevalence of ADHD is particularly high in certain populations, affecting up to 25-30% of children born prematurely and around 20% of children with neurological conditions such as epilepsy. This disorder is officially diagnosed from the age of 6, according to current criteria. However, its clinical manifestations appear much earlier, having a significant impact on all aspects of the child's life, particularly in the most severe forms, which are often unrecognised due to a lack of clinical resources, and therefore without appropriate treatment.
The creation of a platform dedicated to children at risk of ADHD will enable specific clinical expertise to be developed, with the aim of proposing early targeted interventions and positively influencing the development of their trajectory. This platform will also aim to develop new diagnostic methods, based on indirect measures of attentional and executive processes, balance and the development of a risk measurement scale. This development is essential, as the assessment tools currently available lack specificity.
In order to demonstrate the reliability of the innovative diagnostic methods proposed, a comparative pilot study between children from the first clinical cohort (N=30) and a group of healthy children of the same age (N=30) will be carried out. This will enable us to study the discrimination of our tools and make any necessary adjustments. This pilot study also includes a longitudinal re-evaluation, at 12 months, of the children in the ADHD cohort, in order to study changes in these biomarkers over time.
Detailed description
ADHD and control patients will be informed of the study at least 1 week before the inclusion visit.
During the inclusion visit, after consent has been obtained from those with parental authority, patients in both groups will be :
- Review of inclusion and non-inclusion criteria
- Neuropsychological assessment: WPPSI-IV; K-CPT
- Self-questionnaires: ADHD-RS preschool version, temperament scale (CBQ)
- Experimental evaluation: Eye movement recording, vestibular examination, postural recording, VVS test Patients in the ADHD group will be reassessed at 12 months using the same procedure as the inclusion visit.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | –ADHD patients group: Assessement at V0 et V12 months Review of inclusion and non-inclusion criteria * Neuropsychological assessment: WPPSI-IV; K-CPT * Self-questionnaires: ADHD-RS preschool version, temperament scale (CBQ) * Experimental evaluation: Eye movement recording, vestibular examination, postural recording, VVS test |
| Control | – | –Control subjects group, with no know conditions or desease affecting development and behavior: assessement only at V0 Review of inclusion and non-inclusion criteria * Neuropsychological assessment: WPPSI-IV; K-CPT * Self-questionnaires: ADHD-RS preschool version, temperament scale (CBQ) * Experimental evaluation: Eye movement recording, vestibular examination, postural recording, VVS test |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 30 children aged between 3 and 5 years and 11 months, with clinical criteria for ADHD, will be compared with 30 healthy children of the same age.
Key inclusion criteria (7 listed)
- For ADHD subjects:
- Children aged between 3.0 and 5 years and 11 months, with clinical criteria for ADHD, according to DSM 5.
- Children followed in the Child and Adolescent Psychiatry Department of Robert Debré Hospital.
- Children naïve to pharmacological treatment for ADHD
- Children between 3.0 - 5 years and 11 months
Key exclusion criteria (4 listed)
- For both groups
- Intellectual disability according to DSM 5 +- WPPSI IV < 70
- Refusal of the child or one of his parents or representatives of parental authority.
- Patient under AME or not affiliated to a social security scheme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Scores obtained in eye tracking tests between the ADHD group and the control group (fixation duration)
Time frame: At baseline
Identification of biomarkers of visual attention by comparing scores obtained in eye-tracking tests between the ADHD group and the control group.
Scores obtained in eye tracking tests between the ADHD group and the control group (latencies)
Time frame: At baseline
Identification of biomarkers of visual attention by comparing scores obtained in eye-tracking tests between the ADHD group and the control group
Scores obtained in eye tracking tests between the ADHD group and the control group (number of errors)
Time frame: At baseline
Identification of biomarkers of visual attention by comparing scores obtained in eye-tracking tests between the ADHD group and the control group
5 secondary outcomes
Scores obtained in vestibular tests in both groups and Progression at 12 months in the ADHD group (clinical exam)
Time frame: At baseline
Scores obtained in Subjective visual vertical test in both groups and Progression at 12 months in the ADHD group
Time frame: At baseline & at 12 months
WPPSI (Wechsler Preschool and Primary Scale of Intelligence) sub-scores in both groups and Progression at 12 months in the ADHD group
Time frame: At baseline & at 12 months
K-CPT (Conners Kiddie Continuous Performance) scores in both groups (impulsivity scores) and Progression at 12 months in the ADHD group
Time frame: At baseline & at 12 months
Parent self-questionnaire scores in both groups and Progression at 12 months in the ADHD group
Time frame: At baseline & at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 ADHD, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 27 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana MOSCOSO, MD (+33(0)1 40 03 22 95, ana.moscoso@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores obtained in eye tracking tests between the ADHD group and the control group (fixation duration) (time frame: At baseline). The study lists 3 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 27 Feb 2026.