UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037289 |
|---|---|
| Receipt number | R000042510 |
| Scientific Title | Effectiveness of hikikomori intervention program for family members: A randomized controlled trial |
| Date of disclosure of the study information | 2019/07/05 |
| Last modified on | 2023/01/13 09:09:17 |
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Basic information
Public title
Effectiveness of hikikomori intervention program for family members: A randomized controlled trial
Acronym
Effectiveness of hikikomori intervention program for family members
Scientific Title
Effectiveness of hikikomori intervention program for family members: A randomized controlled trial
Scientific Title:Acronym
Effectiveness of hikikomori intervention program for family members
Region
| Japan |
Condition
Condition
Hikikomori (social withdrawal)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to evaluate the effectiveness of the family intervention program. The program is an educational program for family members of hikikomori sufferers to obtain the skills in supporting hikikomori sufferers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of score of perceived skills in supporting hikikomori sufferers between intervention group and TAU group after 2 months of participating in the program.
Key secondary outcomes
Changes in scores of each time point (pre-program, post-program, 2 months after the program, 6 months after the program) of self-rated questionnaires: perceived skills in supporting hikikomori sufferers, confidence, stigma toward mental health problems, attitude toward hikikomori sufferers by participants, hikikomori problematic behavior and adaptive behavior. And behavioral changes in hikikomori sufferers reported by participants.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Family intervention program (consisted of 3 sessions, 180 min. per session, held in every other weeks) + TAU (family support)
Interventions/Control_2
TAU group: TAU (family support)
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) Subject who is living with hikikomori sufferers.
(2) Subject who is already utilizing hikikomori support.
(3) Subject who is over 20 years of age.
(4) Duration of hikikomori period of hikikomori sufferer is over six months.
(5) Subject with written informed consent.
Key exclusion criteria
(1) Subject who has already participated in Mental Health First Aid program.
(2) Hikikomori sufferer is regulary utilizing a hikikomori support and/or a psychiatric service.
(3) Subject who has difficulty in literacy of Japanese.
(4) Subject who has difficulty in taking program regulary due to severe physical or mental symptoms.
(5) Harmful behavior (e.g. daily violence) by hikikomori sufferer is confirmed.
(6) Risk of harmful behavior such as severe aggression by hikikomori sufferer is confirmed.
(7) Risk of self-harm of hikikomori sufferers such as self-injury or suicidal thoughts is confirmed.
(8) Subject who is considered as unsuitable for the study by the investigator for other reasons.
Target sample size
80
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
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
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
Grant for clinical cancer research from the Ministry of Health, Labour and Welfare, Japan (Japan Agency for Medical Research and Development: AMED)
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
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
| 2019 | Year | 07 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fpsyt.2022.1029653/full
Number of participants that the trial has enrolled
29
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 01 | Month | 10 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2019 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study was discontinued in December 2020 due to COVID-19 pandemic in Japan.
Management information
Registered date
| 2019 | Year | 07 | Month | 05 | Day |
Last modified on
| 2023 | 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=R000042510
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
