Identification of Early Biomarkers of Pre-school ADHD
ConditionADHD
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-5
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Patient
Group B: Control
Trial outcomes
Primary outcomes
1
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.
Time frame
At baseline2
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
Time frame
At baseline3
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
Time frame
At baselineSecondary outcomes
1
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
Time frame
At baseline2
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
Time frame
At baseline & at 12 months3
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
Time frame
At baseline & at 12 months4
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
Time frame
At baseline & at 12 monthsSponsors and contacts
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Source ClinicalTrials.gov
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