Somatic Symptoms in Autism Spectrum Disorder: Data Integration

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05886361
• Collaborator: (none)
• Enrollment: 1,423
• Actual Duration (Months): 100.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder; Somatic Symptom Disorder	Other: No intervention involved

Study Design

• Study Type: Observational
• Actual Enrollment: 1423 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Somatic Symptoms in Autism Spectrum Disorder: Data Integration
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: May 31, 2022
• Actual Study Completion Date: May 31, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Patient health questionnaire-15, PHQ-15 [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

2. Health assessment questionnairse, HAQ [8 years]

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

3. Beck depression inventory, BDI [8 years]

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

4. Beck anxiety inventory [8 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT05886361
• Other Study ID Numbers: 202206027RINA
• First Posted: Jun 2, 2023
• Last Update Posted: Jun 2, 2023
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Disease; Medically Unexplained Symptoms; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive

Study Results

No Results Posted as of Jun 2, 2023