Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism (ENIGMA-I)

University College Cork (UCC)

Status: Not yet enrolling

Conditions: Autism Spectrum Disorder; Autism

Study type: Observational

Funder types: Other

Identifiers

NCT06299618

ENIGMA-I

Details and patient eligibility

About

The aim of the study is to enrich the understanding of the physiological mechanisms that predispose autistic adolescents to mental illness. It will inform a possible pathway and biomarker handprint of mental illness severity and prognosis to formulate a neurobiologically informed personalization strategy that could be applied for selecting appropriate Evidence Based Intervention (EBI) for treating an adolescent formally diagnosed with Autism.

Full description

The goal of this observational study is:

1. to identify environmental factors which may significantly contribute to the already vulnerable mental health of autistic adolescents in the age group of 11 - 15 years in developing mental illness;
2. to perform quantitative modelling of the Epigenetic - Genetic/Metabolomic - Mental health (EGM) process chain for designing control strategies based on the subjects' personal, environmental, historical, and current state.

Enrollment: 400 estimated patients

Sex: All

Ages: 11 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Autistic Adolescents
• Must be able to interact verbally
• Parental consent and participants must be able and willing to give written informed assent and to comply with the requirements of the study protocol
• Must be willing to return for all study visits and wear the study device at home
• Must have access to and be able to operate a smartphone.

Exclusion criteria

• Adolescents with severe motor impairments or schizophrenia
• Complex medical conditions, which would interfere with ability to take part in the study visits or outcomes.
• Intellectual disability, not capable to attend mainstream school