About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
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