Somatic Symptoms in Autism Spectrum Disorder: Data Integration
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Patient health questionnaire-15, PHQ-15
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 15 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •psychiatric disorders such as schizophrenia, mood disorder.
- •major physical disorder which can be potentially lethal
- •who cannot read or comprehend the survey and questionnaire
Arms & Interventions
ASD
Diagnosed with DSM-5 autism spectrum disorder
Intervention: No intervention involved (Other)
Clinical
Patients with anxiety, depression, somatic symptoms which are non-psychotic and non-organic
Intervention: No intervention involved (Other)
Control
Healthy control without psychiatric disorder or chronic somatic symptoms
Intervention: No intervention involved (Other)
Outcomes
Primary Outcomes
Patient health questionnaire-15, PHQ-15
Time Frame: 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
Time Frame: 8 years
range from 0 to 3 for each item. Higher the score, worse the disability
Beck depression inventory, BDI
Time Frame: 8 years
range from 0 to 3 for each item. Higher the score, worse the depression
Beck anxiety inventory
Time Frame: 8 years
range from 0 to 3 for each item. Total score 0 to 63. Higher the score, worse the anxiety
Beck anxiety inventory
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported