Identification of Early Biomarkers of Pre-school ADHD

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Scores obtained in eye tracking tests between the ADHD group and the control group (fixation duration) [Срок оценки: At baseline]
• Scores obtained in eye tracking tests between the ADHD group and the control group (latencies) [Срок оценки: At baseline]
• Scores obtained in eye tracking tests between the ADHD group and the control group (number of errors) [Срок оценки: At baseline]

Вторичные конечные точки (5)

• Scores obtained in vestibular tests in both groups and Progression at 12 months in the ADHD group (clinical exam) [Срок оценки: At baseline]
• Scores obtained in Subjective visual vertical test in both groups and Progression at 12 months in the ADHD group [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At baseline & at 12 months]
• Parent self-questionnaire scores in both groups and Progression at 12 months in the ADHD group [Срок оценки: At baseline & at 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 1 центр

• Robert Debré Hospital — Paris

Идентификаторы

NCT: NCT07440992 · APHP251111 · 2025-A01707-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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