Identification of Early Biomarkers of Pre-school ADHD

Starting soon

Conditions studied: ADHD

In brief

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.

Key facts

Study ID

NCT07440992

Run by

Assistance Publique - Hôpitaux de Paris

People needed

60

Starts

2026-03-01

Expected to finish

2028-03-01

Last updated by the study team

2026-02-27

Who can join

Age: 3 and older, up to 5. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Robert Debré Hospital — Paris, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.