UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027252 |
|---|---|
| Receipt number | R000031221 |
| Scientific Title | Single-arm Strengths-based Program to raise self-esteem among Hikikomori |
| Date of disclosure of the study information | 2017/05/05 |
| Last modified on | 2022/05/12 08:14:21 |
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Basic information
Public title
Single-arm Strengths-based Program to raise self-esteem among Hikikomori
Acronym
Strengths-based Program for Hikikomori
Scientific Title
Single-arm Strengths-based Program to raise self-esteem among Hikikomori
Scientific Title:Acronym
Strengths-based Program for Hikikomori
Region
| Japan |
Condition
Condition
Hikikomori
Classification by specialty
| Psychiatry | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether Strengths-based Program can raise self-esteem among hikikomori
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-esteem (Rosenberg's Self-esteem Scale)
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
Strengths-based Program
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
| 15 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those who participate in MILESTONE 3-month Program for Hikikomori
2) Those who do not work or go to school, just staying home for more than 3 months with few interactions with people other than their family members. The reason of this situation is not due to psychological disorders.
3) Those who are able to agree on the written informed consent. (If they are under 18 years old, their parents also need to agree on the written informed consent.)
4) Those who can attend 9 sessions for the 3 months.
5) Those who can complete every homework.
Key exclusion criteria
1) Those who are judged that they are not in a condition where they can participate by the staff of the research team.
2) Those who go to see a psychiatrist for psychological reasons.
3) Those whose K6 score is more than 8. (Those who might have depression or anxiety disorder)
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Kawashima |
Organization
Keio University
Haneginomori Eye Clinic
Division name
School of Medicine
Zip code
160-8582
Address
4-26-4, Daita, Setagaya-ku, Tokyo
TEL
080-4148-3260
motoko-k@a3.keio.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Matsuguma |
Organization
Highbrow corporation
Division name
MILESTONE
Zip code
180-0003
Address
Nanai Building 210, 1-31-2, Kichijyouji-minamimachi, Musashino City, Tokyo
TEL
080-1530-9781
Homepage URL
milestone0201@gmail.com
Sponsor or person
Institute
Highbrow corporation
Institute
Department
Personal name
Funding Source
Organization
Highbrow corporation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Haneginomori Eye Clinic
Address
4-26-4 Daita Setagaya-ku Tokyo
Tel
03-6265-8777
satchin0809@gmail.com
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
| 2017 | Year | 05 | Month | 05 | 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
15
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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 05 | Day |
Last modified on
| 2022 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031221
