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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
EEG-Based Effective Brain Connectivity Network (EBCN) Features for ASD/ADHD Prediction - OS1
Timeframe: Baseline (6 months corrected age), 12 months, 18 months, and 24 months
Effective Brain Connectivity Networks (EBCN) Features for ASD/ADHD Prediction - OS1
Timeframe: Baseline (6 months corrected age), 12 months, 18 months, and 24 months
Clinical Diagnosis of ASD and/or ADHD - OS1
Timeframe: 42 months (corrected age)
DNA Methylation Profiles from Buccal Swabs - OS1 and OS2
Timeframe: Baseline (6 months corrected age), 12 months, 18 months, and 24 months for OS1. Baseline, 3 months, 6 months and 9 months for OS2
Metabolomic Signatures from Stool and Urine - OS1 and OS2
Timeframe: Baseline (6 months corrected age), 12 months, 18 months, and 24 months for OS1. Baseline, 3 months, 6 months and 9 months for OS2
Shotgun Metagenomic Microbiome Profiles from Stool - OS1 and OS2
Timeframe: Baseline (6 months corrected age), 12 months, 18 months, and 24 months for OS1. Baseline, 3 months, 6 months and 9 months for OS2
General Cognitive Development - OS1
Timeframe: Baseline (6 months corrected age), 12 months, 18 months, 24 months, and 42 months
Attention Function - OS1
Timeframe: Baseline (6 months corrected age), 12 months, 18 months, 24 months, and 42 months
Temperament Assessment - OS1
Timeframe: Baseline (6 months corrected age), 12 months, 18 months, 24 months, and 42 months
Anxiety Symptoms - OS1
Timeframe: Baseline (6 months corrected age), 12 months, 18 months, 24 months, and 42 months
Executive Functions - OS1
Timeframe: Baseline (6 months corrected age), 12 months, 18 months, 24 months, and 42 months
Social-Communication Skills - OS1
Timeframe: Baseline (6 months corrected age), 12 months, 18 months, 24 months, and 42 months
Autism Traits - OS1
Timeframe: Baseline (6 months corrected age), 12 months, 18 months, 24 months, and 42 months
Quality of Life - OS1
Timeframe: Baseline (6 months corrected age), 12 months, 18 months, 24 months, and 42 months
Dietary Intake - Methyl Donor Nutrients - OS1
Timeframe: Baseline (6 months corrected age), 12 months, 18 months, 24 months, and 42 months
Personal Natural Environment (PNE) Factors Causally Associated with Anxiety and Depression - OS2
Timeframe: Through study completion, up to 36 weeks
Depression Symptoms (Ages 5-10) - OS2
Timeframe: Baseline, 3 months, 6 months and 9 months.
Depression Symptoms (Ages 11-18) - OS2
Timeframe: Baseline, 3 months, 6 months and 9 months.
Depression Symptoms (Ages 19-25) - OS2
Timeframe: Baseline, 3 months, 6 months and 9 months.
Autism Spectrum Disorder Traits (Ages 5-10) - OS2
Timeframe: Baseline only
Autism Spectrum Disorder Traits (Ages 11-25) - OS2
Timeframe: Baseline only
ADHD Symptoms (Ages 5-18) - OS2
Timeframe: Baseline, 3 months, 6 months and 9 months.
Quality of Life (Ages 5-10) - OS2
Timeframe: Baseline, 3 months, 6 months and 9 months.
Quality of Life (Ages 11-18) - OS2
Timeframe: Baseline, 3 months, 6 months and 9 months.
Quality of Life (Ages 19-25) - OS2
Timeframe: Baseline, 3 months, 6 months and 9 months.
Anxiety Symptoms (Ages 5-18) - OS2
Timeframe: Baseline, 3 months, 6 months and 9 months.
Anxiety Symptoms (Ages 19-25) - OS2
Timeframe: Baseline, 3 months, 6 months and 9 months.
Physical Activity Level (Ages 5-18) - OS2
Timeframe: Baseline, 3 months, 6 months and 9 months.
Physical Activity Level (Ages 19-25) - OS2
Timeframe: Baseline, 3 months, 6 months and 9 months.
Objective Physical Activity Measurement - OS2
Timeframe: Between baseline and visit 1 (approximately 2 weeks); then at 12-week intervals through study completion
Dietary Intake - Methyl Donor Nutrients - OS2
Timeframe: Food frequency every 2 weeks and food preference at baseline only
Sleep pattern - Adolescent Sleep Wake Scale (ASWS) - OS2
Timeframe: Baseline, 3 months, 6 months and 9 months.
Outcome 1.b: fNIRS-Based Effective Brain Connectivity Network (EBCN) Features for ASD/ADHD Prediction - OS1
Timeframe: Baseline (6 months corrected age), 12 months, 18 months, and 24 months