跳至主要内容
临床试验/NCT05886361
NCT05886361进行中(未招募)不适用

Somatic Symptoms in Autism Spectrum Disorder: Data Integration

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2022年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
600
试验地点
1
主要终点
Patient health questionnaire-15, PHQ-15

研究概览

简要总结

Autistic patients have higher rates of co-morbid somatic symptoms. Thus, compared to the general population, they experience more health-related concerns, such as autoimmune disease, gastrointestinal disease, cardiovascular disease, and autonomic disorders. On average, an autistic patient's life span is 16 years shorter than that of a non-autistic patient. Furthermore, autistic patients are often unable to convey or communicate their somatic symptoms in a clear and comprehensive manner. This leads to a lack of proper health care provided in a timely manner.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
15 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASD group: diagnosed with DSM-5 autism spectrum disorder
  • clinical group: anxiety, depression, somatic disorder who are non-psychotic and non-organic
  • control group: healthy control without psychiatric disorder or chronic somatic symptoms
  • age between 15 and 70

排除标准

  • psychiatric disorders such as schizophrenia, mood disorder.
  • major physical disorder which can be potentially lethal
  • who cannot read or comprehend the survey and questionnaire

研究组 & 干预措施

ASD

Diagnosed with DSM-5 autism spectrum disorder

干预措施: No intervention involved (Other)

Clinical

Patients with anxiety, depression, somatic symptoms which are non-psychotic and non-organic

干预措施: No intervention involved (Other)

Control

Healthy control without psychiatric disorder or chronic somatic symptoms

干预措施: No intervention involved (Other)

结局指标

主要结局

Patient health questionnaire-15, PHQ-15

时间窗: 8 years

range from 0 to 2 for each item, total score range from 0 to 30. Higher the score, worse the level of somatization

Health assessment questionnairse, HAQ

时间窗: 8 years

range from 0 to 3 for each item. Higher the score, worse the disability

Beck depression inventory, BDI

时间窗: 8 years

range from 0 to 3 for each item. Higher the score, worse the depression

Beck anxiety inventory

时间窗: 8 years

range from 0 to 3 for each item. Total score 0 to 63. Higher the score, worse the anxiety

Beck anxiety inventory

时间窗: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

range from 0 to 3 for each item. Total score 0 to 63. Higher the score, worse the anxiety

Tridimensional Personality Questionnaire (TPQ)

时间窗: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

a 100-item, true/false psychological test, measures three neurotransmitter-linked personality dimensions: 1. novelty seeking. High scores indicate individuals who are adventurous, easily bored, impulsive, and quick to react to new stimuli. Low Scores indicate individuals who are reflective, rigid, orderly, systematic, and comfortable with routine. 2. harm avoidance. High Scores: Indicates individuals who are cautious, fearful, socially inhibited, and prone to worry or depression.Low Scores: Indicates individuals who are confident, carefree, optimistic, relaxed, and resilient to stress. 3. reward dependence. High Scores: Indicates individuals who are warm, empathetic, socially sensitive, and highly motivated by praise.Low Scores: Indicates individuals who are independent, practical, socially detached, and emotionally self-sufficient.

WHO Quality of Life-BREF (WHOQOL-BREF)

时间窗: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

a 26-item survey by the World Health Organization that measures personal well-being across four core domains: physical health, psychological health, social relationships, and environment. Scores are scaled from 0 to 100, where higher numbers show a better quality of life.

Sensory profile

时间窗: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

a standardized questionnaire completed by caregivers, teachers, or individuals to evaluate how a person processes everyday sensory information (like touch, sound, and movement). It measures how a person's nervous system responds to sensory inputs and how those responses affect daily life. Results describe an individual in the following four areas: Seeking: Actively searches for extra sensory input (e.g., loves spinning, crashing into things, chewing objects, or loud music). Sensitivity: Detects sensory input very quickly and easily, noticing small details (e.g., easily distracted by background noise or bright lights). Avoiding: Actively tries to escape or prevent sensory input (e.g., covers ears in loud rooms, refuses certain clothing textures, or avoids crowds). Low Registration: Misses or is slow to notice sensory input (e.g., doesn't respond to their name, seems clumsy, or doesn't notice pain/temperatures).

Social responsiveness scale (SRS)

时间窗: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

a 65-item questionnaire that measures the severity of social impairment and autism spectrum-related traits. It evaluates how a person acts in real-life social settings. Higher scores represent greater impairment.

Autism Spectrum Quotient (AQ)

时间窗: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

The Autism Spectrum Quotient (AQ) is a 50-item self-report questionnaire used to measure autistic traits in adults and teens. Scores range from 0 to 50. A score of 26 or higher suggests elevated autistic traits, while 32 or higher indicates a strong presence of these traits.

Empathy Quotient (EQ)

时间窗: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

The Empathy Quotient (EQ) is a self-report questionnaire developed by psychologist Simon Baron-Cohen to measure a person's ability to understand others' thoughts and feel appropriate emotional responses. The standard test has 60 items (40 scored statements and 20 filler questions) spanning cognitive empathy, emotional reactivity, and social skills. Higher scores indicate higher empathy levels.

Patient health questionnaire-15, PHQ-15

时间窗: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

range from 0 to 2 for each item, total score range from 0 to 30. Higher the score, worse the level of somatization

Health assessment questionnaire, HAQ

时间窗: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

range from 0 to 3 for each item. Higher the score, worse the disability

Beck depression inventory, BDI

时间窗: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

range from 0 to 3 for each item. Higher the score, worse the depression

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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