UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033677 |
|---|---|
| Receipt number | R000030290 |
| Scientific Title | Promoting father's child rearing behaviors and preventing paternal and maternal postpartum depression: evaluation of the antenatal couple-based parenting support program |
| Date of disclosure of the study information | 2018/08/08 |
| Last modified on | 2018/08/08 11:28:17 |
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Basic information
Public title
Promoting father's child rearing behaviors and preventing paternal and maternal postpartum depression: evaluation of the antenatal couple-based parenting support program
Acronym
Promoting father's child rearing behaviors and preventing paternal and maternal postpartum depression
Scientific Title
Promoting father's child rearing behaviors and preventing paternal and maternal postpartum depression: evaluation of the antenatal couple-based parenting support program
Scientific Title:Acronym
Promoting father's child rearing behaviors and preventing paternal and maternal postpartum depression
Region
| Japan |
Condition
Condition
couples expecting babies
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate an antenatal couple-based parenting support program aiming to promote father's child rearing behaviors and to prevent paternal and maternal postpartum depression. The intervention will be implemented by several organizations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Edinburgh Postnatal Depression Scale at one and a half months after the expected date of delivery
Questionaire about father's child rearing behaviors
Key secondary outcomes
Face scale
Multi-dimensional 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
Couple participate antenatal Empathy Session for 2 hours and additional information is mailed a week after the Session and 6 weeks after childbirth.
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
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiij Yasumura |
Organization
Fukushima Medical University
School of Medicine
Division name
Department of Public Health
Zip code
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1180
yasumura@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kayoko Ishii |
Organization
Fukushima Medical University
Division name
Radiation Medical Science Center
Zip code
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1723
Homepage URL
kayokoi@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
School of Medicine
Department of Public Health
Institute
Department
Personal name
Funding Source
Organization
Foundation for Total Health Promotion
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 08 | Month | 08 | 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
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
| 2016 | Year | 04 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 08 | Day |
Last modified on
| 2018 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030290
