UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048907 |
|---|---|
| Receipt number | R000055725 |
| Scientific Title | The development and evaluation of an online program to enhance parenthood for Japanese fathers of infants |
| Date of disclosure of the study information | 2022/09/10 |
| Last modified on | 2023/09/21 16:41:58 |
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Basic information
Public title
The online program to enhance parenthood for Japanese fathers of infants
Acronym
Parenthood to online program for father
Scientific Title
The development and evaluation of an online program to enhance parenthood for Japanese fathers of infants
Scientific Title:Acronym
Parenthood to online program for father
Region
| Japan |
Condition
Condition
parenthood
Classification by specialty
| Nursing | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The researchers will conduct an online program developed for this study to demonstrate the effects of the program by evaluating fathers' self efficacy, their expectations around childcare, what they expect to achieve through participating in childcare, childcare and housework behaviors, parenting skills prior to and following completion of the program, and by comparing the results of the subject group with the control group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
parenthood
self-efficacy for child care
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The program promotes fathers' participation in childcare and housework by improving their self-efficacy in childcare which leads to improved parenting. This program comprises lectures, viewing of 4 video programs about caregiving and how to engage with babies, and groupwork. Participants in the intervention group are required to participate in the first session and the second session, which is held 2 weeks after the first one. The second session consists of group work.
Interventions/Control_2
Participants in both the intervention group and the control group are required to answer 2 questionnaires in a 4-month period (baseline survey and follow-up survey 4 months later).
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Research subjects are first time fathers who have 1 to 2 month old babies.
Key exclusion criteria
Those who are unable to participate in the online program (due to lack of internet connection and a device such as a personal computer or tablet), or who have other children, are eliminated from the research.
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Adachi |
| Middle name | |
| Last name | Yasumasa |
Organization
Osaka Prefecture University
Division name
Graduate School of Nursing
Zip code
583-8555
Address
3-7-30 Habikino, Habikino City, Osaka, 583-8555, Japan
TEL
072-950-2111
db601001@st.osakafu-u.ac.jp
Public contact
Name of contact person
| 1st name | Adachi |
| Middle name | |
| Last name | Yasumasa |
Organization
Setsunan University
Division name
Faculty of Nursing
Zip code
573-0101
Address
45-1 Nagaotoge-cho, Hirakata City, Osaka, 573-0101, Japan
TEL
072-800-1411
Homepage URL
yasumasa.adachi@nrs.setsunan.ac.jp
Sponsor or person
Institute
Osaka Prefecture 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
Osaka Prefecture University
Address
3-7-30 Habikino, Habikino City, Osaka, 583-8555, Japan
Tel
072-950-2111
db601001@st.osakafu-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
| 2022 | Year | 09 | 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 | 08 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 10 | Day |
Last modified on
| 2023 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055725
| 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 |
