Somatic Symptoms in Autism Spectrum Disorder: Data Integration

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 Overview

• Status: Active, not recruiting
• Conditions: Autism Spectrum Disorder; Somatic Symptom Disorder
• Intervention / Treatment: Other: No intervention involved

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective study of existing data. Data from several hundred individuals was previously collected in other studies. These existing data are separated into three groups, as mentioned in the eligibility criteria

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ASD; Diagnosed with DSM-5 autism spectrum disorder	Other: No intervention involved; No intervention involved
Clinical; Patients with anxiety, depression, somatic symptoms which are non-psychotic and non-organic	Other: No intervention involved; No intervention involved
Control; Healthy control without psychiatric disorder or chronic somatic symptoms	Other: No intervention involved; No intervention involved

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient health questionnaire-15, PHQ-15	range from 0 to 2 for each item, total score range from 0 to 30. Higher the score, worse the level of somatization	Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
Health assessment questionnaire, HAQ	range from 0 to 3 for each item. Higher the score, worse the disability	Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
Beck depression inventory, BDI	range from 0 to 3 for each item. Higher the score, worse the depression	Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
Beck anxiety inventory	range from 0 to 3 for each item. Total score 0 to 63. Higher the score, worse the anxiety	Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
Tridimensional Personality Questionnaire (TPQ)	a 100-item, true/false psychological test, measures three neurotransmitter-linked personality dimensions: 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.; 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.; 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.	Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
WHO Quality of Life-BREF (WHOQOL-BREF)	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.	Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
Sensory profile	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).	Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
Social responsiveness scale (SRS)	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.	Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
Autism Spectrum Quotient (AQ)	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.	Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
Empathy Quotient (EQ)	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.	Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 13, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Autism spectrum disorder; Sensory sensitivity; Somatic symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Autism Spectrum Disorder; Medically Unexplained Symptoms; Anxiety Disorders; Depression
• Other Study ID Numbers: 202206027RINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No