UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046425 |
|---|---|
| Receipt number | R000052964 |
| Scientific Title | The effectiveness of providing childcare support information corresponding to Mother's Characteristics: a randomized controlled trial |
| Date of disclosure of the study information | 2021/12/22 |
| Last modified on | 2025/03/03 19:33:09 |
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Basic information
Public title
The effectiveness of providing childcare support information corresponding to Mother's Characteristics
Acronym
The effectiveness of providing childcare support information corresponding to Mother's Characteristics
Scientific Title
The effectiveness of providing childcare support information corresponding to Mother's Characteristics: a randomized controlled trial
Scientific Title:Acronym
The effectiveness of providing childcare support information corresponding to Mother's Characteristics: a randomized controlled trial
Region
| Japan |
Condition
Condition
childcare
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the previous study, we stratified mothers based on human characteristics factors such as their personality and developmental characteristics, as well as living environment factors, and developed a scale that can predict the child-rearing difficulties faced by mothers with these stratified characteristics. In addition, we developed childcare support information corresponding to these characteristics.
In this study, we will clarify whether mothers' knowledge of their own characteristics and the getting support information corresponding to their characteristics are effective in reducing their sense of difficulty on child-rearing
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological Adaptation to Parenting score in Comprehensive Scale for Parenting Resilience and Adaptation
Key secondary outcomes
EPDS and POMS2
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
We provide support information during pregnancy.
Interventions/Control_2
We provide support information between postpartum day0 and day7.
Interventions/Control_3
We provide support information after the one-month postpartum checkup.
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 | months-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Women experiencing pregnancy, delivery, and childcare up to one month checkup.
Key exclusion criteria
Cases resulting in miscarriage or intrauterine fetal death.
Target sample size
830
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Endo |
Organization
Osaka University
Division name
Graduate School of Medicine, Health Science
Zip code
565-0871
Address
1-7 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-2533
mendoh@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayaka |
| Middle name | |
| Last name | Naruto |
Organization
Osaka University
Division name
Graduate School of Medicine, Health Science
Zip code
565-0871
Address
1-7 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-2533
Homepage URL
aya.naruto@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethic Review Board Osaka University Hospital
Address
2-2 Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8286
rinri@hp-crc.med.osaka-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
| 2021 | Year | 12 | Month | 22 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2021 | Year | 12 | Month | 21 | Day |
Last modified on
| 2025 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052964
