UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051579 |
|---|---|
| Receipt number | R000058539 |
| Scientific Title | Prenatal and Postnatal education programs to support the transition to parenthood for first time fathers |
| Date of disclosure of the study information | 2023/07/11 |
| Last modified on | 2023/07/11 16:15:38 |
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Basic information
Public title
Prenatal and Postnatal education programs to support the transition to parenthood for first time fathers
Acronym
Prenatal and Postnatal education programs to support the transition to parenthood for first time fathers
Scientific Title
Prenatal and Postnatal education programs to support the transition to parenthood for first time fathers
Scientific Title:Acronym
Prenatal and Postnatal education programs to support the transition to parenthood for first time fathers
Region
| Japan |
Condition
Condition
normal heaith
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Develop a prenatal and postnatal education program to support the transition to parenthood for for first time fathers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Creation a Scale of Father Identity in the Transition Period
Key secondary outcomes
The Center for Epidemiologic Studies Depression Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
Learning about good marital relationships and postanal life with childcare
Interventions/Control_2
life as usual
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
Partners of pregnant women who are pregnant with their first child
Key exclusion criteria
mental illness
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Seiko |
| Middle name | |
| Last name | Akeno |
Organization
Health Sciences University of Hokkaido
Division name
Department of Nursing
Zip code
0610293
Address
1757 Kanazawa,Tobetsu-cho,Ishikari-gun,Hokkaido,061-9293 JAPAN
TEL
0133231367
naga-s@hoku-iryo-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiko |
| Middle name | |
| Last name | Akeno |
Organization
Health Sciences University of Hokkaido
Division name
Department of Nursing
Zip code
0610293
Address
1757 Kanazawa,Tobetsu-cho,Ishikari-gun,Hokkaido,061-9293 JAPAN
TEL
0133231367
Homepage URL
naga-s@hoku-iryo-u.ac.jp
Sponsor or person
Institute
Health Sciences University of Hokkaido
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Health Sciences University of Hokkaido
Address
1757 Kanazawa,Tobetsu-cho,Ishikari-gun,Hokkaido,061-9293 JAPAN
Tel
0133231367
naga-s@hoku-iryo-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
| 2023 | Year | 07 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2023 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 05 | 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
| 2023 | Year | 07 | Month | 11 | Day |
Last modified on
| 2023 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058539
