UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045208 |
|---|---|
| Receipt number | R000051464 |
| Scientific Title | Development and effectiveness verification of online educational program for Hikikomori sufferers and their supporters: Pilot study using single arm design |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2024/02/26 15:10:47 |
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Basic information
Public title
Development and effectiveness verification of online educational program for Hikikomori sufferers and their supporters: Pilot study using single arm design
Acronym
Development and effectiveness verification of online educational program for Hikikomori
Scientific Title
Development and effectiveness verification of online educational program for Hikikomori sufferers and their supporters: Pilot study using single arm design
Scientific Title:Acronym
Development and effectiveness verification of online educational program for Hikikomori
Region
| Japan | Europe |
Condition
Condition
Social Withdrawal (Hikikomori)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With the aim of establishing a comprehensive online support system for hikikomori sufferers, we will develop online programs and verify those effectiveness for parties in various positions, such as (1) the general public, (2) family members of hikikomori sufferers, (3) hikikomori sufferers themselves, and (4) supporters of hikikomori. Since hikikomori cases tend to be biased toward short-sighted perspectives and interventions, we will develop a program incorporating the concept of "Future Design" (Saijo, 2018) and our MHFA and CRAFT-based face-to-face family program (Kubo et al., 2020) to understand hikikomori from a broader and more flexible perspective as well as a long-term perspective that looks to the future.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Programs for the general public, family members, and supporters: Change in scores of skills for coping with persons with hikikomori situations.
Program for hikikomori sufferers: Change in scores of depressive symptoms
Key secondary outcomes
-Program for the general public: Changes between pre and post program in knowledge about hikikomori and its related mental disorders, prejudice, confidence in coping, understanding of hikikomori situations based on Future Design and broadening of perspectives. Implementation of work during the program, and feedback on the program.
Amount of change in the following items before, after, one month after, and six months after participation in the program.
-Program for family members and supporters: Changes in knowledge about hikikomori and its related mental disorders, prejudice, confidence in coping, understanding of hikikomori situation based on Future Design and changes in perspective, implementation of work in the program, changes in hikikomori situation of the participant him/herself at the time of follow-up survey; changes in the participants' involvement with the person with hikikomori at the time of the follow-up survey, and their impressions of the program.
-Program for hikikomori sufferers : Change in understanding of hikikomori, change in understanding of situation based on Future Design and changes in perspective, implementation of work during the program, change in his/her own hikikomori status and the the tendency at the follow-up survey, and impressions of the program.
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
Recruitment of potential participants will be conducted through a webpage developed for this study. Four types of online support programs (for the gereral public; family members; individuals with hikikomori situations; supporters) will be developed according to the relationship with the hikikomori sufferers, and participants who give consent online will take the programs, answer online questionnaires, and view feedback.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Program for the general public
a) Over 20 years old
b) With online informed consent
2. Program for family members of hikikomori sufferers
a) Being concerned with hikikomori member (mainly, parent)
b) Hikikomori period is over 6 months
c) Over 20 years old
d) With online informed consent
3. Program for individuals with hikikomori situations
a) Hikikomori period is over 6 months
b) Over 20 years old
c) With online informed consent
4. Program for supporters of hikikomori sufferers
a) A member of a support organization for hikikomori cases (individuals/families) and has experience in supporting them.
b) Over 20 years old
c) With online informed consent
Key exclusion criteria
1. Program for the general public
a) Unable to read or write Japanese
b)Difficulty in attending the program due to severe disease
c) Others inappropriate for the study
2. Program for family members of hikikomori sufferers
a) Unable to read or write Japanese
b)Difficulty in attending the program due to severe disease
c) Possibility of self-harm/violence of the hikikomori sufferer and difficulty in coping with the situation by online intervention alone
d) Others inappropriate for the study
3. Program for individuals with hikikomori situations
a) Unable to read or write Japanese
b)Difficulty in attending the program due to severe disease
c) Possibility of self-harm/violence of the hikikomori sufferer and difficulty in coping with the situation by online intervention alone
d) Others inappropriate for the study
4. Program for supporters of hikikomori sufferers
a) Unable to read or write Japanese
b)Difficulty in attending the program due to severe disease
c) Others inappropriate for the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Kato |
Organization
Kyushu University
Division name
Department of Neuropsychiatry Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
TEL
092-642-5627
kato.takahiro.015@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Kato |
Organization
Kyushu University
Division name
Department of Neuropsychiatry Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
TEL
092-642-5627
Homepage URL
kato.takahiro.015@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Kyushu University Hospital IRB
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.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
| 2021 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
COVID-19 has made it difficult to recruit research participants and has caused delays in this research.
Management information
Registered date
| 2021 | Year | 08 | Month | 20 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051464
