Biomarkers of ASD/ADHD and Factors Affecting Anxiety and Depression in Children and Young Adults

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.

NCT Number	NCT07570381
Lead Sponsor	University of Exeter Collaborators: University of Southampton, University of Dublin, Trinity College, Carol Davila University of Medicine and Pharmacy, Jimma University, FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS, International Centre for Diarrhoeal Disease Research, Bangladesh, University of Bari Aldo Moro
Conditions	ADHD - Attention Deficit Disorder With Hyperactivity, Autism Spectrum Disorder (ASD), Developmental Coordination Disorder (DCD)
Enrollment	800 participants
Start Date	2026-08-01
Primary Completion	2028-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-06