Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Autism, Autism Spectrum Disorder. Basic parameters: 11 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland, Romania, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Primary outcome measures
- Symptoms of anxiety [Time frame: Months 0-6]
- Symptoms of anxiety [Time frame: Months 0-6]
- Symptoms of depression [Time frame: Months 0-6]
- Symptoms of depression [Time frame: Months 0-6]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Ireland · 1 center
- University College Cork — Cork
Romania · 1 center
- University of Medicine and Pharmacy Carol Davila Bucharest — Bucharest
United Kingdom · 1 center
- University of Southampton — Southampton
Identifiers
NCT: NCT06299618 · ENIGMA-I