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

Email

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


Email

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

Email

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