UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058223 |
|---|---|
| Receipt number | R000066566 |
| Scientific Title | Verification of the effectiveness of a modular prenatal education program that combines coparenting and empathy sessions |
| Date of disclosure of the study information | 2025/06/19 |
| Last modified on | 2025/06/19 16:00:15 |
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Basic information
Public title
Verification of the effectiveness of a modular prenatal education program that combines coparenting and empathy sessions
Acronym
Coparenting Module Cohort Study
Scientific Title
Verification of the effectiveness of a modular prenatal education program that combines coparenting and empathy sessions
Scientific Title:Acronym
Coparenting Module Cohort Study
Region
| Japan |
Condition
Condition
Pregnant couples, parenting couples
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of a modular prenatal education program that combines a co-parenting promotion program with empathy sessions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Parental role adaptation (depression, parenting stress, parenting self-efficacy)
Key secondary outcomes
Base
Study type
Observational
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This class includes a "modular prenatal education program" that combines co-parenting and empathy sessions. It is intended for couples who are expecting a new baby (pregnant couples) and couples with children under one year old (including common-law couples) who have access to the internet via a smartphone or computer (required for registration and questionnaire responses).
Key exclusion criteria
Those who cannot read or write Japanese
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuka |
| Middle name | |
| Last name | NAKAMURA |
Organization
Yamagata Prefectural University of Health Sciences
Division name
Health Sciences
Zip code
9902212
Address
260Kamiyanagi, Yamagata city, Yamagata
TEL
0236866620
ynakamura@yachts.ac.jp
Public contact
Name of contact person
| 1st name | Yasuka |
| Middle name | |
| Last name | NAKAMURA |
Organization
Yamagata Prefectural University of Health Sciences
Division name
Health Sciences
Zip code
9902212
Address
260Kamiyanagi, Yamagata city, Yamagata
TEL
0236866620
Homepage URL
ynakamura@yachts.ac.jp
Sponsor or person
Institute
Yamagata Prefectural University of Health Sciences
Institute
Department
Personal name
Yasuka NAKAMURA
Funding Source
Organization
KAKENHI
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
Yamagata Prefectural University of Health Sciences Ethics Committee
Address
260Kamiyanagi, Yamagata city, Yamagata
Tel
0236866620
ynakamura@yachts.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
山形県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 19 | 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 | 06 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NP
Management information
Registered date
| 2025 | Year | 06 | Month | 19 | Day |
Last modified on
| 2025 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066566
