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

Email

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


Email

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

Email

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