UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042236 |
|---|---|
| Receipt number | R000048207 |
| Scientific Title | A randomized controlled trial of a web-based personalized parenting program for prevention of postpartum depression and child maltreatment |
| Date of disclosure of the study information | 2020/10/26 |
| Last modified on | 2023/10/29 14:52:23 |
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Basic information
Public title
Research for healthy parenting
Acronym
Research for healthy parenting
Scientific Title
A randomized controlled trial of a web-based personalized parenting program for prevention of postpartum depression and child maltreatment
Scientific Title:Acronym
A randomized controlled trial of a web-based personalized parenting program
Region
| Japan |
Condition
Condition
Postpartum depression and child maltreatment
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of a web-based personalized parenting program on postpartum depression and child maltreatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maternal-infant bonding at 3 months and 1 year after birth
Key secondary outcomes
Postpartum depression, parenting behavior, help-seeking behavior, perception of infant crying and sleep at 3 months and 1 year after birth
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Distributing a QR code for a web-based personalized parenting program at 36 weeks pregnant. The website provides personalized parenting skills according to types of pregnant women.
Interventions/Control_2
Distributing a QR code for a website developed by Tokyo prefecture including information related to parenting at 36 weeks pregnant
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
Female
Key inclusion criteria
Pregnant women who have a midwife appointment at 36 weeks pregnant or who are hospitalized at 36 weeks or later
Key exclusion criteria
Pregnant women who cannot read or write Japanese, Pregnant women whom a doctor or midwife judge as difficult to be recruited
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Takeo |
| Middle name | |
| Last name | Fujiwara |
Organization
Tokyo Medical and Dental University
Division name
Department of Global Health Promotion
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5187
fujiwara.hlth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Isumi |
Organization
Tokyo Medical and Dental University
Division name
Department of Global Health Promotion
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5188
Homepage URL
https://moshipri.jp/
isumi.hlth@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Metropolitan Otsuka Hospital
Name of secondary funder(s)
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5096
syomu1.adm@tmd.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
東京医科歯科大学医学部附属病院 （東京都）、都立大塚病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 26 | 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
301
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
It took longer time to recruit due to COVID-19 pandemic.
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
| 2020 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 26 | Day |
Last modified on
| 2023 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048207
