UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062403 |
|---|---|
| Receipt number | R000071395 |
| Scientific Title | A Study of the Association Between Developmental Disorder Traits and Quality of Life Through Generative AI Dependence Tendencies Among University Students |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/30 13:26:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study of the Association Between Developmental Disorder Traits and Quality of Life Through Generative AI Dependence Tendencies Among University Students
Acronym
A Study of the Association Between Developmental Disorder Traits and Quality of Life Through Generative AI Dependence Tendencies Among University Students
Scientific Title
A Study of the Association Between Developmental Disorder Traits and Quality of Life Through Generative AI Dependence Tendencies Among University Students
Scientific Title:Acronym
A Study of the Association Between Developmental Disorder Traits and Quality of Life Through Generative AI Dependence Tendencies Among University Students
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
The use of generative AI among university students is rapidly expanding, and it is increasingly being applied in various aspects of university life, including academic study and daily activities. The principal investigator has conducted preliminary research on generative AI dependence tendencies among university students with neurodevelopmental traits. The findings suggested that ASD and ADHD symptoms may influence QOL through generative AI dependence tendencies. Therefore, the present study will examine the pathways through which ASD and ADHD symptoms influence QOL via generative AI dependence tendencies, using a sample size calculated on the basis of the effect sizes and other estimates obtained from the preliminary study.
Basic objectives2
Others
Basic objectives -Others
To examine the associations between generative AI dependence tendencies and psychosocial factors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Pathways Through Which ASRS and RAADS-14 Scores Influence WHOQOL-26 Scores via the Subscale Scores of the Generative AI Dependence Tendency Scale for High School and University Students.
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Individuals who understand the purpose of the study and provide written informed consent to participate
2.Individuals who are currently enrolled as university students
3.Individuals aged 18-29 years at the time of study participation
Key exclusion criteria
None.
Target sample size
300
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 | 08 | Month | 01 | 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
| 2026 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | 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
| 2026 | Year | 07 | Month | 30 | Day |
Last modified on
| 2026 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071395
