Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Symptoms of anxiety
研究概览
简要总结
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.
详细描述
The goal of this observational study is:
- 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;
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Symptoms of anxiety
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Dr. Deirdre Murray
Professor Deirdre Murray
University College Cork