UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059595 |
|---|---|
| Receipt number | R000067034 |
| Scientific Title | Effectiveness of a program to promote parenting behavior among fathers with newborns: RCT |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2025/10/30 18:37:21 |
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Basic information
Public title
Effectiveness of a program to promote parenting behavior among fathers with newborns: RCT
Acronym
Effectiveness of a program to promote parenting behavior among fathers with newborns: RCT
Scientific Title
Effectiveness of a program to promote parenting behavior among fathers with newborns: RCT
Scientific Title:Acronym
Effectiveness of a program to promote parenting behavior among fathers with newborns: RCT
Region
| Japan |
Condition
Condition
Fathers with newborns
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effectiveness of the program to promote parenting behavior among fathers with newborns
Basic objectives2
Others
Basic objectives -Others
To improve the program to promote parenting behavior among fathers with newborns
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of fathers' parenting behavior one week after discharge of newborns from hospital.
Key secondary outcomes
fathers' parenting self-efficacy, fathers' parenting behavioral intentions
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
We provide a program to promote good parenting behavior for fathers of newborns (lectures on holding, bottle-feeding, venting, changing diapers, soothing techniques, etc., and practice with their own infants).
Interventions/Control_2
Receive the usual support of the maternity facility
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
Father of first infant / No congenital abnormalities / Early neonatal period
Key exclusion criteria
Unable to read Japanese / Not seeing the infant for one week after discharge from the maternity facility / Having previously raised a biological infant / Cases where the newborn requires medical treatment
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Misato |
Organization
Kyoritsu Women's University
Division name
Faculty of Nursing
Zip code
1010051
Address
3-27 kanda Jimbocho, Chiyoda-ku, Tokyo 101-0051, JAPAN
TEL
0332375667
kmisato@kyoritsu-wu.ac.jp
Public contact
Name of contact person
| 1st name | kumiko |
| Middle name | |
| Last name | Misato |
Organization
Kyoritsu Women's University
Division name
Faculty of Nursing
Zip code
1010051
Address
3-27, Kandajimbocho
TEL
0332375667
Homepage URL
kmisato@kyoritsu-wu.ac.jp
Sponsor or person
Institute
Kyoritsu Women's University
Institute
Department
Personal name
Kumiko Misato
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
Kyoritsu Women's University and Kyoritsu Women's Junior College Research Ethics Review Committee
Address
3-27, Kandajimbocho
Tel
0332375667
kmisato@kyoritsu-wu.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
Tokyo
Institutions
Institutions
堀病院（神奈川県）、並木産婦人科（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | 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
| 2025 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 30 | Day |
Last modified on
| 2025 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067034
