UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049270 |
|---|---|
| Receipt number | R000056108 |
| Scientific Title | Implementation and Evaluation of a Web-Based Mother-Child Support Class for Reducing Depression for Mothers Raising Infants |
| Date of disclosure of the study information | 2022/10/20 |
| Last modified on | 2024/04/21 19:29:28 |
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Basic information
Public title
Implementation and Evaluation of a Web-Based Mother-Child Support Class for Reducing Depression for Mothers Raising Infants
Acronym
Implementation and Evaluation of a Web-Based Mother-Child Support Class for Reducing Depression for Mothers Raising Infants
Scientific Title
Implementation and Evaluation of a Web-Based Mother-Child Support Class for Reducing Depression for Mothers Raising Infants
Scientific Title:Acronym
Implementation and Evaluation of a Web-Based Mother-Child Support Class for Reducing Depression for Mothers Raising Infants
Region
| Japan |
Condition
Condition
Mothers Raising Infants
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the usefulness of web-based mother-child support classes and changes in depression for mothers raising children under one year of age in a COVID-19-infected situation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
depression
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
A Web-Based Mother-Child Support Class
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1) Mothers who are raising a child under 1 year old.
(2) Mothers who can communicate in Japanese and answer the questionnaire.
(3) Mothers who are able to set up a communication environment, communication costs, and zoom settings at home.
Key exclusion criteria
(1) Infants with skin problems and their mothers.
After the application for participation in research cooperation, the researchers will check with the mothers to see if their infants have any skin problems, and if adverse effects from baby massage are anticipated, a decision will be made to exclude them from the subjects.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Asazawa |
Organization
Tokyo Healthcare University
Division name
Higashigaoka Faculty of Nursing
Zip code
152-8558
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
0357795031
k-asazawa@thcu.ac.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Asazawa |
Organization
Tokyo Healthcare University
Division name
Higashigaoka Faculty of Nursing
Zip code
1520021
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
0357795031
Homepage URL
k-asazawa@thcu.ac.jp
Sponsor or person
Institute
Tokyo Healthcare University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
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
Tokyo Healthcare University
Address
4-1-17 higashigotanda, Shinagawa-ku, Tokyo
Tel
03-5421-7685
kenkyo@thcu.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 | 10 | Month | 20 | 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
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 20 | Day |
Last modified on
| 2024 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056108
