Identification of Early Biomarkers of Pre-school ADHD

NCT07440992 | Not Yet Recruiting

• 2 other identifiers: APHP2511112025-A01707-42
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Psychiatry; pediatry; ADHD

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  At baseline

Secondary Outcomes (5)

• Scores obtained in vestibular tests in both groups and Progression at 12 months in the ADHD group (clinical exam)

  At baseline

• Scores obtained in Subjective visual vertical test in both groups and Progression at 12 months in the ADHD group

  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

  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

  At baseline & at 12 months

• Parent self-questionnaire scores in both groups and Progression at 12 months in the ADHD group

  At baseline & at 12 months

Study Arms (2)

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

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debré Hospital

Paris, 75019, France

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Ana MOSCOSO, MD

CONTACT

+33(0)1 40 03 22 95; ana.moscoso@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

FR (1)