UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050557 |
|---|---|
| Receipt number | R000057578 |
| Scientific Title | Effective support to promote fatherhood role adaptation in the new normal era. |
| Date of disclosure of the study information | 2023/03/10 |
| Last modified on | 2023/03/10 12:45:38 |
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Basic information
Public title
Effective support to promote fatherhood role adaptation in the new normal era.
Acronym
Effective support to promote fatherhood role adaptation in the new normal era.
Scientific Title
Effective support to promote fatherhood role adaptation in the new normal era.
Scientific Title:Acronym
Effective support to promote fatherhood role adaptation in the new normal era.
Region
| Japan |
Condition
Condition
father
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify effective support for fathers who have become fathers for the first time after the outbreak of COVID-19, to promote adaptation to the father's role (reasons for being able to implement their own father's role behavior and support felt to be effective).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To qualitatively evaluate effective support that promotes adaptation to the father's role for those who became fathers after January 2020.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
We will target men who became fathers for the first time after the outbreak of COVID-19 (i.e. those who had a child born after January 2020) and who meet the following criteria:
They must be first-time fathers.
Their child must be at least 4 months old.
Their child must have been born at full term and both the child and parent must be healthy.
We will not exclude participants based on whether they have experience living separately from their child and partner, but they must have some experience living with them.
The parents must be married.
Key exclusion criteria
in case there is something abnormal with the wife and child
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | AKIKO |
| Middle name | |
| Last name | MORITA |
Organization
Juntendo University
Division name
Faculty of health care and nursing
Zip code
279-0023
Address
2-5-1 Takasu Urayasu Chiba Japan
TEL
0473504065
a.morita.zj@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | AKIKO |
| Middle name | |
| Last name | MORITA |
Organization
Juntendo University
Division name
Faculty of health care and nursing
Zip code
279-0023
Address
2-5-1 Takasu Urayasu Chiba Japan
TEL
0473504065
Homepage URL
a.morita.zj@juntendo.ac.jp
Sponsor or person
Institute
Juntendo university
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Juntendo University
Address
2-5-1 Takasu Urayasu Chiba Japan
Tel
0473504065
a.morita.zj@juntendo.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 | 03 | Month | 10 | 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
| 2022 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
qualitative interview
Management information
Registered date
| 2023 | Year | 03 | Month | 10 | Day |
Last modified on
| 2023 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057578
