UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062520 |
|---|---|
| Receipt number | R000071563 |
| Scientific Title | Development of Wellbeing Assessment Measures for University Students and Youth and Examination of Its Associated Factors |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2026/08/07 19:20:40 |
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Basic information
Public title
Youth Wellbeing Questionnaire Survey
Acronym
Youth Wellbeing Survey
Scientific Title
Development of Wellbeing Assessment Measures for University Students and Youth and Examination of Its Associated Factors
Scientific Title:Acronym
WISE(Wellbeing In Students and Emerging adults)
Region
| Japan |
Condition
Condition
Not Applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine methods for assessing wellbeing among university students and youth, and to identify the factors associated with their wellbeing, thereby informing the development of approaches to enhance wellbeing and the improvement of counseling and support services.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to explore a range of factors potentially associated with wellbeing and to propose theoretical hypotheses regarding how wellbeing is fostered.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Standardisation of wellbeing measures (WHO-5 Well-Being Index, Warwick-Edinburgh Mental Well-being Scale, Cantril Ladder, Human Rights-Based Wellbeing Checklist, Interdependent Happiness Scale)
Key secondary outcomes
Mental health (K-6, psychotic-like experiences, suicidal ideation, self-harm)
Social media use (Social Media Disorder Scale)
Adverse childhood experiences, trauma exposure and PTSD (PTSD Checklist for DSM-5)
Social support (Oslo Social Support Scale)
Loneliness (UCLA Loneliness Scale)
Sleep disturbance (Athens Insomnia Scale)
Young carer experiences (Young Carers Scale, Japanese version)
Generative AI use (original items)
Help-seeking attitudes (Japanese version of the ATSPPH-SF)
Over-Adaptation Scale for Adults
Other original items (climate change, armed conflict, health behaviors, etc.)
Base
Study type
Observational
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Residents of Japan:
those aged 18-29 years old including students(vocational colleges, technical colleges, universities, and graduate schools), employed individuals, and individuals not in employment
employed individuals aged 30-64 years old
2) Able to respond to the questionnaire items in Japanese
Key exclusion criteria
No exclusion criteria are applied.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Eizaburo |
| Middle name | |
| Last name | Tanaka |
Organization
The University of Tokyo
Division name
Center for Research on Counseling and Support Services, Campus Wellbeing Promotion Unit
Zip code
1138654
Address
7-3-1 Hongo Bunkyoku Tokyo
TEL
09099687695
eizaburo-tanaka@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Eizaburo |
| Middle name | |
| Last name | Tanaka |
Organization
The University of Tokyo
Division name
Center for Research on Counseling and Support Services, Campus Wellbeing Promotion Unit
Zip code
1138654
Address
7-3-1 Hongo Bunkyoku Tokyo
TEL
09099687695
Homepage URL
eizaburo-tanaka@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo, Life Science Ethics and Safety
Address
7-3-1 Hongo Bunkyoku Tokyo
Tel
0338122111
lifescience@adm.u-tokyo.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 | 31 | 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 | 01 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, a self-administered online questionnaire survey will be conducted with participants recruited through a Japanese survey company: 2000 students aged 18-29, 1000 non-students in the same age range, and 2000 employed individuals aged 30-64. The survey items comprise primary outcome measures (wellbeing-related indicators), secondary outcome measures (mental health and related domains), and basic demographic characteristics.
After descriptive statistics are calculated, the cross-sectional data will be analysed as follows:
Assessment of the reliability and validity of the WHO-5 in the general adult population
Association between social media use disorder and wellbeing, and public opinion regarding the appropriate age for initiating social media use
Association between young carer experiences and wellbeing
Associations of adverse childhood experiences, trauma exposure, and PTSD with wellbeing
Assessment of the reliability and validity of the Human Rights-Based Wellbeing Checklist
Association between AI use and wellbeing
Exploration of other factors associated with wellbeing
Linear regression or logistic regression analyses will be conducted to examine the relationships between exposure variables and wellbeing after adjustment for related factors.
Management information
Registered date
| 2026 | Year | 08 | Month | 07 | Day |
Last modified on
| 2026 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071563
