Somatic Symptoms in Autism Spectrum Disorder: Data Integration

Autism Spectrum Disorder Clinical Trial

Official title:

Somatic Symptoms in Autism Spectrum Disorder: Data Integration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05886361
• Other study ID #: 202206027RINA
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2022
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Autistic patients have higher chances commorbid somatic symptoms. Therefore, it leads to more health-related concerns, such as autoimmune disease, gastrointestinal disease, cardiovascular disease, autonomic disorders. On average, autistic patient's life span is 16 years shorter than non-autistic patients. Furthermore, autistic patients are not able to convey or communicate their somatic symptoms in a clear and comprehensive manner. This leads to unable to receive proper health care in a timely manner.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1423
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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 schezophrenia, mood disorder.
• major physical disorder which can be potentially lethal
• who cannot read or comprehend the survey and questionnaire

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease
• Medically Unexplained Symptoms
• Somatic Symptom Disorder

Intervention

Other:
• No intervention involved
No intervention involved

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 years
Primary	Health assessment questionnairse, HAQ	range from 0 to 3 for each item. Higher the score, worse the disability	8 years
Primary	Beck depression inventory, BDI	range from 0 to 3 for each item. Higher the score, worse the depression	8 years
Primary	Beck anxiety inventory	range from 0 to 3 for each item. Total score 0 to 63. Higher the score, worse the anxiety	8 years