UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063211 |
|---|---|
| Receipt number | R000065408 |
| Scientific Title | Development and effectiveness of a program to promote parenting behavior among fathers with newborns: a randomized controlled trial |
| Date of disclosure of the study information | 2026/10/07 |
| Last modified on | 2026/10/07 21:48:29 |
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Basic information
Public title
Development and effectiveness of a program to promote parenting behavior among fathers with newborns: a randomized controlled trial
Acronym
Effectiveness of a support program among fathers with newborns
Scientific Title
Development and effectiveness of a program to promote parenting behavior among fathers with newborns: a randomized controlled trial
Scientific Title:Acronym
Effectiveness of a support program among fathers with newborns
Region
| Japan |
Condition
Condition
Fathers of first child within 7 days of birth
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a program to promote parenting behavior among fathers with newborns
Basic objectives2
Others
Basic objectives -Others
To evaluate the effectiveness of the program
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of father's parenting behavior one week after discharge from hospital for newborns
Key secondary outcomes
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
Fathers attend one private parenting behavior promotion program before the newborn is discharged from the birth facility.
Interventions/Control_2
Normal supports of the birth 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Fathers of first child
Postpartum partners and newborns who are making normal progress
Key exclusion criteria
Partners or newborns deviate from the normal course of events
Fathers who have difficulty communicating in Japanese
Fathers who have no plans to visit during hospitalization
Target sample size
156
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
03-3237-5667
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
101-0051
Address
3-27 kanda Jimbocho, Chiyoda-ku, Tokyo 101-0051, JAPAN
TEL
03-3237-5667
Homepage URL
kmisato@kyoritsu-wu.ac.jp
Sponsor or person
Institute
Kyoritsu Women's University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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 kanda Jimbocho, Chiyoda-ku, Tokyo 101-0051, JAPAN
Tel
03-3237-2523
k-shien.gr@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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 07 | 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
160
Results
Of the 160 participants, 79 were assigned to the intervention group and 81 to the control group. The mean score for the frequency of infant care behaviors at one week after discharge was 4.7 (SD = 1.3) in both the intervention and control groups. In the ITT analysis, simple linear regression analysis using multiple imputation showed that the intervention was not significantly associated with the frequency of infant care behaviors one week after discharge.
Results date posted
| 2026 | Year | 10 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 160 first-time fathers who were consented to participate in the study, and were randomized to the intervention (n = 79) or the control (n = 81) group. A total of 18 participants (11.3%) did not return the second survey questionnaire one week after discharge, including five (6.3%) in the intervention group and 13 (16.0%) in the control group. No significant between-group differences were observed in age, the number of non-working days during the first week after discharge, prior infant care experience, or attendance at prenatal classes for fathers.
Participant flow
Adverse events
Outcome measures
Frequency of infant care behaviors, Attitudes, subjective norms, perceived behavioral control, and behavioral intention toward infant care, Self-efficacy in infant care
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 07 | Day |
Last modified on
| 2026 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065408
