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Looking for early signs of autism and ADHD, and what affects anxiety and depression

Follows children and young people with autism, ADHD or coordination difficulties to find early markers.

Key facts

Who runs it
University of Exeter
Where
Exeter, United KingdomSee the site
Trial code
Registry title
Biomarkers of ASD/ADHD and Factors Affecting Anxiety and Depression in Children and Young Adults
Status
Not yet recruiting
People taking part
800 people, planned
Started
1 Aug 2026
Expected to end
31 Dec 2028
Type of study
Observational, 4 groups
Record updated
6 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for infants at risk of autism or ADHD (study 1), and children and young adults aged 5-25 with autism, ADHD or developmental coordination disorder (study 2).

Age
Study 1: up to 12 months corrected age. Study 2: 5-25 years.
Sex
All sexes can join.
Disease stage
Study 1: infants born very preterm (<32 weeks) or extremely preterm (<28 weeks), or term-born infants with perinatal asphyxia and hypoxic-ischaemic encephalopathy (HIE), or term-born infants with no risk factors (comparison group). Study 2: a clinical diagnosis of ASD, ADHD or Developmental Coordination Disorder (DCD).

Main reasons for not taking part

  • Syndromic, chromosomal or known genetic conditions (study 1)
  • Motor impairments that prevent the assessments (study 1)
  • Severe motor impairments that limit psychometric assessment (study 2)
  • Diagnosis of schizophrenia (study 2)

The registry criteria, word for word

Show all 12 criteriaShow less

Other criteria

  • OS1 Inclusion Criteria:
  • 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; OS1 Exclusion Criteria:
  • Syndromic, chromosomal, or known genetic conditions
  • Motor impairments that would prevent participation in psychometric or neurophysiology assessments; OS2 Inclusion Criteria:
  • Individuals aged 5-25 years
  • Clinical diagnosis of ASD, ADHD, or Developmental Coordination Disorder (DCD)
  • Able to participate in scheduled assessments; OS2 Exclusion Criteria:
  • Severe motor impairments that limit psychometric assessment
  • Diagnosis of schizophrenia, due to confounding neurocognitive effects

Where in United Kingdom

  • University Of ExeterExeter, United KingdomContact: Kim ChapmanNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 4 groups in the trial

  • OS1 0-4

    Newborns and infants up to 12 months of age

  • OS1 5-10

    Children aged between 5 and 10 years old

  • OS2 11-18

    Adolescents aged between 11 and 18 years old

  • OS2 19-25

    Young adults aged between 19 and 25 years old

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Biomarker Discovery for Predicting Autism Spectrum Disorder and Attention/Hyperactivity Disorders, and Identification of Environmental Factors Influencing Anxiety and Depression in Children, Adolescents, and Young Adults
Plain-language title
Looking for early signs of autism and ADHD, and what affects anxiety and depressionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
6 May 2026