NCT05886361

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,423

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
Last Updated

June 2, 2023

Status Verified

June 1, 2022

Enrollment Period

8.4 years

First QC Date

May 4, 2023

Last Update Submit

May 23, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • Health assessment questionnairse, HAQ

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

    8 years

  • Beck depression inventory, BDI

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

    8 years

  • Beck anxiety inventory

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

    8 years

Study Arms (3)

ASD

Diagnosed with DSM-5 autism spectrum disorder

Other: No intervention involved

Clinical

Patients with anxiety, depression, somatic symptoms which are non-psychotic and non-organic

Other: No intervention involved

Control

Healthy control without psychiatric disorder or chronic somatic symptoms

Other: No intervention involved

Interventions

No intervention involved

ASDClinicalControl

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

as mentioned earlier, it is a retrospective study with existed data. Therefore, the 1423 participants are already collected in the past. We separate these existed data into three groups as mentioned in the eligibility criteria

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2023

First Posted

June 2, 2023

Study Start

January 1, 2014

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

June 2, 2023

Record last verified: 2022-06