UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051473 |
|---|---|
| Receipt number | R000058384 |
| Scientific Title | Online Implementation and Intervention Effectiveness of a Perinatal Parenting Program for Parents |
| Date of disclosure of the study information | 2023/07/09 |
| Last modified on | 2025/01/07 18:58:49 |
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Basic information
Public title
A Study of Online Implementation and Intervention Effectiveness of a Seamless Parenting Program from Pregnancy to Postpartum for Parents
Acronym
Seamless parenting program for parents from pregnancy to postpartum
Scientific Title
Online Implementation and Intervention Effectiveness of a Perinatal Parenting Program for Parents
Scientific Title:Acronym
Perinatal parenting program for parents
Region
| Japan |
Condition
Condition
Couples during pregnancy and postpartum
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to confirm the intervention effectiveness of an unbroken parenting support program from pregnancy to postpartum for parents by implementing the program online and establishing a control group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Edinburgh Postnatal Depression Scale
Key secondary outcomes
Marital Satisfaction Scale, Multidimensional Empathy Scale
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Implement childcare support programs during pregnancy and postpartum, respectively.
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
Male and Female
Key inclusion criteria
Couples expecting babies
Key exclusion criteria
Women with medical complications and their husbands
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | Ishii |
Organization
Fukushima Medical University
Division name
School of Nursing
Zip code
9601295
Address
1 Hikarigaoka, Fukushima City, Fukushima, JAPAN
TEL
024-547-1854
kayokoi@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Kayoko |
| Middle name | |
| Last name | Ishii |
Organization
Fukushima Medical University
Division name
School of Nursing
Zip code
9601295
Address
1 Hikarigaoka, Fukushima City, Fukushima, JAPAN
TEL
024-547-1854
Homepage URL
kayokoi@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Fukushima Medical University
Address
1 Hikarigaoka, Fukushima City, Fukushima, JAPAN
Tel
090-1938-7374
c-kiban@fmu.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
| 2023 | Year | 07 | Month | 09 | 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
| 2023 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 09 | 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
| 2023 | Year | 06 | Month | 28 | Day |
Last modified on
| 2025 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058384
