UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053139 |
|---|---|
| Receipt number | R000060644 |
| Scientific Title | Development of a sibling version of the family peer learning program for families of people with mental disabilities - feasibility and preliminary study |
| Date of disclosure of the study information | 2023/12/18 |
| Last modified on | 2024/12/18 18:49:53 |
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Basic information
Public title
Development of a sibling version of the family peer learning program for families of people with mental disabilities - feasibility and preliminary study
Acronym
Sibling version of the family peer learning program
Scientific Title
Development of a sibling version of the family peer learning program for families of people with mental disabilities - feasibility and preliminary study
Scientific Title:Acronym
Sibling version of the family peer learning program
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to conduct a sibling version of the family peer learning program using an original text and to study the feasibility of the program.
Basic objectives2
Others
Basic objectives -Others
Examine feasibility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Posttraumatic Growth (pre test and post test)
Key secondary outcomes
Sense of Coherence (pre test and post test)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
With family members as 'participants' and family members in the same position as 'in charge', in small groups of 10-15 people, for three hours per session, five sessions per course, an original textbook is read in a circle and the family members discuss their 'experiential knowledge' as well as their knowledge of the disease and how to deal with it.
Interventions/Control_2
With family members as 'participants' and family members in the same position as 'in charge', in small groups of 7-10 people, for three hours per session, three sessions per course, an original textbook is read in a circle and the family members discuss their 'experiential knowledge' as well as their knowledge of the disease and how to deal with it.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The participants must be adult siblings over the age of 18 who have a sibling with a mental illness. There is no upper age limit for the first course, and for the second course, participants must be in their 30s or older.
Key exclusion criteria
no criteria
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Yokoyama |
Organization
YOKOHAMA SOEI UNIVERSITY
Division name
Faculty of Nursing
Zip code
226-0015
Address
Miho-cho1, Midori, Yokohama, Kanagawa, Japan
TEL
045-922-6232
kyokoyama@soei.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Yokoyama |
Organization
YOKOHAMA SOEI UNIVERSITY
Division name
Faculty of Nursing
Zip code
226-0015
Address
Miho-cho1, Midori, Yokohama, Kanagawa, Japan
TEL
045-922-6232
Homepage URL
kyokoyama@soei.ac.jp
Sponsor or person
Institute
YOKOHAMA SOEI UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama Soei University Research Ethics Review Board
Address
Miho-cho 1, Midori, Yokohama
Tel
045-922-6105
kikaku@soei.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
| 2023 | Year | 12 | Month | 18 | 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
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 16 | Day |
Date trial data considered complete
| 2024 | Year | 10 | Month | 16 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 18 | Day |
Last modified on
| 2024 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060644
