Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism

Not yet recruiting

• Conditions: Autism; Autism Spectrum Disorder

• Registration Number: NCT06299618
• Lead Sponsor: University College Cork

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.

Study Timeline

• Study First Submitted: 2023-06-23
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Study Start: 2024-09
• Primary Completion: 2025-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptoms of anxiety	Months 0-6	Symptoms of anxiety will be assessed via the Revised Children's Anxiety and Depression Scale-25 (RCADS-25).; The RCADS-25 is a 25-item self-report, rendering an anxiety subscale with 14 items. Items are scored on a 4-point Likert scale with higher scores representing greater symptom severity. Scores for the anxiety subscale range from 0 to 42. The RCADS-25 will be completed biweekly over the 6-month study duration.
Symptoms of depression	Months 0-6	Symptoms of depression will be assessed via Revised Children's Anxiety and Depression Scale-25 (RCADS-25).; The RCADS-25 is a 25-item self-report, rendering a depression subscale with 10 items. Items are scored on a 4-point Likert scale with higher scores representing greater symptom severity. Scores for the depression subscale range from 0 to 30. The RCADS-25 will be completed biweekly over the 6-month study duration.

Trial Locations

Locations (3)

University College Cork; 🇮🇪 Cork, Ireland

University of Medicine and Pharmacy Carol Davila Bucharest; 🇷🇴 Bucharest, Romania

University of Southampton; 🇬🇧 Southampton, United Kingdom