UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060243 |
|---|---|
| Receipt number | R000068847 |
| Scientific Title | A Study of High Stress Classification and Associated Factors among Workers with Neurodevelopmental Traits |
| Date of disclosure of the study information | 2026/01/06 |
| Last modified on | 2025/12/28 16:58:24 |
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Basic information
Public title
A Study of High Stress Classification and Associated Factors among Workers with Neurodevelopmental Traits
Acronym
A Study of High Stress Classification and Associated Factors among Workers with Neurodevelopmental Traits
Scientific Title
A Study of High Stress Classification and Associated Factors among Workers with Neurodevelopmental Traits
Scientific Title:Acronym
A Study of High Stress Classification and Associated Factors among Workers with Neurodevelopmental Traits
Region
| Japan |
Condition
Condition
Attention-Deficit/Hyperactivity Disorder and Autism Spectrum Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japan, under the Stress Check Program mandated by the Industrial Safety and Health Act, employers are required to implement appropriate work-related measures for workers who are classified as high stress. However, empirical research has not examined which psychosocial factors-such as occupational stressors, workplace support, and stress coping strategies-are associated with high-stress classification among workers who exhibit neurodevelopmental traits, including symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD). This study will focus on workers with ADHD and/or ASD symptoms and will examine the effects of occupational stressors, workplace support, and stress coping strategies on high-stress classification.
Basic objectives2
Others
Basic objectives -Others
This study will examine the differences and associations in psychosocial factors among workers with ADHD and ASD symptoms, will examine how these individuals perceive the COVID-19 pandemic, and will provide empirical data that will serve as a theoretical basis for the effectiveness of interpersonal counseling as a future psychological intervention.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effects of subscale scores of the Brief Job Stress Questionnaire and the Brief Scales for Coping Profile on high-stress classification.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals who understand the purpose of the study and have provided written informed consent to participate
2. Individuals aged 18 years or older at the time of study participation
3. Individuals who reported being currently employed in the screening survey
4. Individuals who were identified as having ADHD symptoms or ASD symptoms in the screening survey
Key exclusion criteria
None.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Hisae |
| Middle name | |
| Last name | Ono |
Organization
Kwansei Gakuin University
Division name
Department of Integrated Psychological Sciences, School of Humanities
Zip code
662-8501
Address
1-155 Uegahara Ichibancho, Nishinomiya, Hyogo
TEL
0798-54-4517
hisaono@kwansei.ac.jp
Public contact
Name of contact person
| 1st name | Hisae |
| Middle name | |
| Last name | Ono |
Organization
Kwansei Gakuin University
Division name
Department of Integrated Psychological Sciences, School of Humanities
Zip code
662-8501
Address
1-155 Uegahara Ichibancho, Nishinomiya, Hyogo
TEL
0798-54-4517
Homepage URL
hisaono@kwansei.ac.jp
Sponsor or person
Institute
Kwansei Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Kwansei Gakuin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kwansei Gakuin University Institutional Review Board for Medical and Biological Research Involving Human Subiects(KGIRB)
Address
1 Ban Gakuen Uegahara, Sanda-shi, Hyogo
Tel
079-565-9052
med-ethic@kwansei.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Online cross-sectional study
Management information
Registered date
| 2025 | Year | 12 | Month | 31 | Day |
Last modified on
| 2025 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068847
