UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060332 |
|---|---|
| Receipt number | R000068953 |
| Scientific Title | Development of a Screening Scale for Problematic Smartphone Use (Data Collection Study) |
| Date of disclosure of the study information | 2026/01/16 |
| Last modified on | 2026/01/13 02:06:48 |
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Basic information
Public title
Development of a Screening Scale for Problematic Smartphone Use (Data Collection Study)
Acronym
Development of a Screening Scale for Problematic Smartphone Use (Data Collection Study)
Scientific Title
Development of a Screening Scale for Problematic Smartphone Use (Data Collection Study)
Scientific Title:Acronym
Development of a Screening Scale for Problematic Smartphone Use (Data Collection Study)
Region
| Japan |
Condition
Condition
Disorders due to addictive behaviors,Gaming disorder,Hazardous gaming
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to develop a novel screening scale for Problematic Smartphone Use (PSU) by integrating existing measures related to cognitive, behavioral, and individual characteristics.
Basic objectives2
Others
Basic objectives -Others
In this phase, we aim to collect large-scale foundational data required for scale development.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the latent trait structure and psychometric properties of the scale, estimated using item response theory (IRT) based on questionnaire items related to Problematic Smartphone Use (PSU).
Key secondary outcomes
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
| 13 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were as follows: (1) ownership of and experience using a smartphone; (2) age 13 years or older at the time of consent; and (3) provision of electronic informed consent (or assent with parental consent, as appropriate).
Key exclusion criteria
Exclusion criteria were as follows: (1) difficulty understanding the study instructions or questionnaire content; (2) lack of access to the internet required to complete the web-based survey; and (3) medical advice restricting the use of electronic devices, including smartphones
Target sample size
30000
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Jitoku |
Organization
Institute of Science Tokyo
Division name
Department of Cyber Psychiatry
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan
TEL
03-5803-5238
jitopsyc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Macromill, |
| Middle name | |
| Last name | Inc. |
Organization
Macromill, Inc.
Division name
Inquiry Form
Zip code
108-0075
Address
11F, Shinagawa East One Tower, 2-16-1 Konan, Minato-ku, Tokyo
TEL
03-6716-0700
Homepage URL
info@macromill.com
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
KDDI Research, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Kobuna Orthopedic Clinic, Ko-yukai Medical Corporation
Address
311-2 Gokan-cho, Maebashi, Gunma 371-0813, Japan
Tel
027-212-5608
sagawa@mc-connect.co.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 | 16 | 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 | 09 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a non-interventional, anonymous observational study using self-administered questionnaires on smartphone use. No medical intervention, drugs, or devices are involved, and data are collected through a web-based survey.
Management information
Registered date
| 2026 | Year | 01 | Month | 13 | Day |
Last modified on
| 2026 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068953
