UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059485 |
|---|---|
| Receipt number | R000068040 |
| Scientific Title | A study on strategies to turn farms into social resources that can be used by people who are withdrawn from society |
| Date of disclosure of the study information | 2025/10/21 |
| Last modified on | 2025/10/21 13:04:01 |
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Basic information
Public title
A study on strategies to turn farms into social resources that can be used by people who are withdrawn from society
Acronym
A study on strategies to turn farms into social resources that can be used by people who are withdrawn from society
Scientific Title
A study on strategies to turn farms into social resources that can be used by people who are withdrawn from society
Scientific Title:Acronym
A study on strategies to turn farms into social resources that can be used by people who are withdrawn from society
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this project is to consider strategies for meeting local hikikomori individuals and connecting them to the farm, by what means and timing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Information and activities to inspire local hikikomori and lead them to social participation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Semi-structured interviews based on an interview guide will be conducted with users attending the Niigata City Hikikomori Support Center who have agreed to be interviewed (approximately five people).
The interview content will be organized using SCAT to summarize what information people were interested in, when, and how it could serve as a point of contact with society.
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
| 16 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
People with experience of hikikomori participating in activities at the Niigata City Hikikomori Support Center.
Key exclusion criteria
Nothing in particular
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Fumiya |
| Middle name | |
| Last name | Arai |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Social Welfare Department of Social Welfare
Zip code
9503198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-257-4455
swa22055@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Fumiya |
| Middle name | |
| Last name | Arai |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Social Welfare Department of Social Welfare
Zip code
9503198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-257-4738
Homepage URL
swa22055@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology, National Institute of Science and Technology Policy
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
Niigata University of Health and Welfare Ethics Review Committee
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
Tel
025-257-4455
rinri@nuhw.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
| 2025 | Year | 10 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 21 | Day |
Last modified on
| 2025 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068040
