The PUREMIND OS1/OS2 study is a multinational, prospective, longitudinal observational study designed to identify early neurophysiological, biological, environmental, and psychosocial markers associated with neurodevelopmental and mental health conditions from infancy through young adulthood.
Observational Study 1 (OS1) follows infants and toddlers at high risk for Autism Spectrum Disorder (ASD) and Attention-Deficit/Hyperactivity Disorder (ADHD) to discover biomarkers predictive of later clinical diagnosis, using EEG, fNIRS, psychometric assessments, and biological samples.
Observational Study 2 (OS2) includes children, adolescents, and young adults with ASD, ADHD, or Developmental Coordination Disorder (DCD) to identify environmental and biological factors causally linked to anxiety and depression symptoms, and to support the development of personalised criteria for evidence-based interventions.
Approximately 800 participants will be recruited across 10 international clinical sites. The study aims to generate multi-domain data to support predictive modelling and inform future personalised mental-health prevention strategies across childhood and young adulthood.
Infants born very preterm (<32 weeks) or extremely preterm (<28 weeks); or
Term-born infants with documented perinatal asphyxia and hypoxic-ischaemic encephalopathy (HIE); or
Term-born infants with no risk factors (comparison group).
Must be ≤12 months corrected age at enrolment.
Syndromic, chromosomal, or known genetic conditions.
Motor impairments that would prevent participation in psychometric or neurophysiology assessments.
Individuals aged 5-25 years.
Clinical diagnosis of ASD, ADHD, or Developmental Coordination Disorder (DCD).
The study will recruit approximately 800 participants from early infancy to young adulthood across 10 international sites. OS1 will include infants at increased neurodevelopmental risk: very or extremely preterm infants (\<32 or \<28 weeks), term-born infants with perinatal asphyxia or hypoxic-ischaemic encephalopathy, and a comparison group of term-born infants without risk factors. Infants are enrolled within the first 12 months and followed to 42 months. OS2 will include children (5-10 years), adolescents (11-18 years), and young adults (19-25 years) with confirmed diagnoses of ASD, ADHD, or DCD, conditions linked to elevated anxiety and depression risk. Recruitment aims for balanced sex representation and diverse socioeconomic and cultural backgrounds.
Cohort
Prospective
Not listed
EEG-Based Effective Brain Connectivity Network (EBCN) Features for ASD/ADHD Prediction - OS1
Quantitative features extracted from single-layer and multi-layer effective brain connectivity networks using electroencephalography (EEG). These features characterize directional, causal interactions between brain regions using Granger Causality and Dynamic Causal Modelling, generating dimensionless connectivity indices (ranging 0-1) to identify early neurophysiological markers predictive of Autism Spectrum Disorder (ASD) and/or Attention-Deficit/Hyperactivity Disorder (ADHD) diagnosis at 42 months of age.
Effective Brain Connectivity Networks (EBCN) Features for ASD/ADHD Prediction - OS1
Composite score derived from quantitative graph-theoretical features extracted from multilayer effective brain connectivity networks constructed using simultaneous electroencephalography (EEG, 32-channel) and functional near-infrared spectroscopy (fNIRS, 24-channel). Features quantify directional causal interactions between brain regions using Granger Causality and/or Dynamic Causal Modelling methods. Machine learning algorithms will integrate multiple EBCN features to generate a single predictive probability score (range 0-1, where higher values indicate greater likelihood of ASD/ADHD diagnosis) indicating likelihood of Autism Spectrum Disorder (ASD) and/or Attention-Deficit/Hyperactivity Disorder (ADHD) diagnosis at 42 months of age.
Clinical Diagnosis of ASD and/or ADHD - OS1
Clinical diagnosis of Autism Spectrum Disorder (ASD) and/or Attention-Deficit/Hyperactivity Disorder (ADHD) established using ICD-11 and DSM-5-TR diagnostic criteria administered by qualified clinicians.
DNA Methylation Profiles from Buccal Swabs - OS1 and OS2
Epigenetic DNA methylation profiles analyzed from buccal swab samples using standard microarray technique. Methylation levels are measured as beta values representing the proportion of methylated cytosines at specific CpG sites.
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University of Exeter
Lead sponsor
University of Southampton
Collaborator
University of Dublin, Trinity College
Collaborator
Carol Davila University of Medicine and Pharmacy
Collaborator
Jimma University
Collaborator
FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborator
University of Bari Aldo Moro
Collaborator
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