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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-25
SponsorUniversity of Exeter

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

800 Participants
are grouped into 4 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