Autism Spectrum DisorderNCT05886361
Somatic Symptoms in Autism Spectrum Disorder: Data Integration
An observational study of Autism Spectrum Disorder and Somatic Symptom Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Somatic Symptom Disorder
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- psychiatric disorders such as schizophrenia, mood disorder.
- major physical disorder which can be potentially lethal
- who cannot read or comprehend the survey and questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Autism Spectrum Disorder, Somatic Symptom Disorder
- Being tested
- No intervention involved
- Keywords
- Autism spectrum disorder, Somatic symptoms, Sensory sensitivity, Anxiety, Depression
- Medical subject headings
- Autism Spectrum Disorder, Medically Unexplained Symptoms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention involvedOther
No intervention involved
| Study group | Role | What they receive |
|---|---|---|
| ASD | Diagnosed with DSM-5 autism spectrum disorder Receives: Other: No intervention involved | |
| Clinical | Patients with anxiety, depression, somatic symptoms which are non-psychotic and non-organic Receives: Other: No intervention involved | |
| Control | Healthy control without psychiatric disorder or chronic somatic symptoms Receives: Other: No intervention involved |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Jul 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886361
- Sponsor's protocol ID
- 202206027RINA
- Status last verified
- Aug 2026
- First submitted
- 4 May 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatic Symptoms in Autism Spectrum Disorder: Data Integration
- ClinicalTrials.gov ID
- NCT05886361
- Acronym / sponsor ID
- 202206027RINA
- Conditions
- Autism Spectrum Disorder, Somatic Symptom Disorder
- Keywords
- Autism spectrum disorder, Somatic symptoms, Sensory sensitivity, Anxiety, Depression
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASD | – | Other: No intervention involvedDiagnosed with DSM-5 autism spectrum disorder |
| Clinical | – | Other: No intervention involvedPatients with anxiety, depression, somatic symptoms which are non-psychotic and non-organic |
| Control | – | Other: No intervention involvedHealthy control without psychiatric disorder or chronic somatic symptoms |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- psychiatric disorders such as schizophrenia, mood disorder.
- major physical disorder which can be potentially lethal
- who cannot read or comprehend the survey and questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention involvedNo intervention involved | Other | ASD, Clinical, Control |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Somatic Symptom Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient health questionnaire-15, PHQ-15 (time frame: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.