Clinical trial NCT06299618: Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism
Official title: Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Autism
Autism Spectrum Disorder
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: University of Southampton
name: Carol Davila University of Medicine and Pharmacy
name: Microlink PC UK LTE
name: Engineering Ingegneria Informatica SpA
name: MEDEA SRL
name: ORTHOKEY ITALIA SRL
First posted: 2024-03-08
Enrollment: 400
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from paediatric and community paediatric clinics. Participants may also be identified through open invitations on websites, social media pages, and through a study specific social media page.

Brief summary: 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.

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

Primary outcomes:
measure: Symptoms of anxiety
timeFrame: Months 0-6
measure: Symptoms of anxiety
timeFrame: Months 0-6
measure: Symptoms of depression
timeFrame: Months 0-6
measure: Symptoms of depression
timeFrame: Months 0-6
Secondary outcomes:
Other outcomes:
measure: Attention-Deficit/Hyperactivity
timeFrame: Months 0-6
measure: Sleep disturbance
timeFrame: Months 0-6
measure: Physical Activity
timeFrame: Months 0-6
measure: Symptoms of Mental Health Disorders
timeFrame: Month 0 and Month 6
measure: Cognitive Assessment
timeFrame: Month 0 and Month 6
measure: Nutritional Assessment
timeFrame: Months 0-6
measure: Heart Rate
timeFrame: Months 0-6
measure: Respiratory Rate
timeFrame: Months 0-6
measure: Genotype
timeFrame: Month 0
measure: DNA Methylation
timeFrame: Months 0-6
measure: Hormone Levels
timeFrame: Months 0-6
measure: Metabolomic Profile
timeFrame: Months 0-6
Locations:
city: Cork
country: Ireland
facility: University College Cork
city: Bucharest
country: Romania
facility: University of Medicine and Pharmacy Carol Davila Bucharest
city: Southampton
country: United Kingdom
facility: University of Southampton
Study officials:
affiliation: University College Cork, Cork, Ireland
name: Deirdre Murray, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University College Cork, Cork, Ireland
name: Geraldine Boylan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Medicine and Pharmacy, Bucharest, Romania
name: Mihai Berteanu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southampton, Southampton, UK
name: Samuele Cortese, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southampton, Southampton, UK
name: Koushik Maharatna, PhD
role: PRINCIPAL_INVESTIGATOR
References: