UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049637 |
|---|---|
| Receipt number | R000056528 |
| Scientific Title | Development and verification of the effect of collaborative support program for couples' childcare using online |
| Date of disclosure of the study information | 2022/11/28 |
| Last modified on | 2026/03/28 13:37:00 |
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Basic information
Public title
Development and verification of the effect of collaborative support program for couples' childcare using online
Acronym
Development and verification of the effect of collaborative support program for couples' childcare using online
Scientific Title
Development and verification of the effect of collaborative support program for couples' childcare using online
Scientific Title:Acronym
Development and verification of the effect of collaborative support program for couples' childcare using online
Region
| Japan |
Condition
Condition
postpartum
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will develop an online collaborative support program for postpartum childcare for first-time couples, and clarify the effectiveness of the program by evaluating collaboration before and after intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 month after intervention
the Japanese Version of the Coparenting Relationship Scale
the Coparental Regulation Inventory
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Collaborative support program for childcare
1 time (80 minutes)
Interventions/Control_2
no intervention
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A Japanese primiparous couple with a two month old first child
Couples who gave birth to a singleton at term
Those who have no problems with the health of the mother, child, or father during pregnancy and after childbirth
Married couples who are both over twenty years old
Both spouses must be able to read write and speak Japanese
A couple living in the same house two months after giving birth
Key exclusion criteria
Other than selection criteria
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Mitsuko |
| Middle name | |
| Last name | Tsuda |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences, Nursing Sciences
Zip code
116-8551
Address
7-2-10 Higashiogu, Arakawa-ku, Tokyo
TEL
03-3819-1211
tsuda-mitsuko@ed.tmu.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuko |
| Middle name | |
| Last name | Tsuda |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences, Nursing Sciences
Zip code
116-8551
Address
7-2-10 Higashiogu, Arakawa-ku, Tokyo
TEL
03-3819-1211
Homepage URL
tsuda-mitsuko@ed.tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan University
Address
7-2-10 Higashiogu, Arakawa-ku, Tokyo
Tel
03-3819-1211
tsuda-mitsuko@ed.tmu.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 | 11 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
135
Results
The results revealed no significant effect of the program on either mothers or fathers (p > 0.05). However, the 95% confidence intervals (CI) of the differences for the intervention group mothers showed an increasing trend in scores on Coparental Regulation Inventory (facilitating behaviors) before and after the program compared with the control group (95% CI [-0.323, 0.003], p = 0.054).
Results date posted
| 2026 | Year | 03 | Month | 28 | Day |
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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 28 | Day |
Last modified on
| 2026 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056528
