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Identification of Early Biomarkers of Pre-school ADHD

NCT07440992 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-02-27

No results posted yet for this study

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 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.

Conditions

  • ADHD

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-03-01
Completion
2028-03-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07440992 on ClinicalTrials.gov