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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020790
Receipt No. R000022682
Scientific Title Antenatal couple-based parenting support for preventing postpartum depression: Clinical application and evaluation of the program
Date of disclosure of the study information 2016/01/29
Last modified on 2019/08/05

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Basic information
Public title Antenatal couple-based parenting support for preventing postpartum depression: Clinical application and evaluation of the program
Acronym Antenatal couple-based parenting support for preventing postpartum depression
Scientific Title Antenatal couple-based parenting support for preventing postpartum depression: Clinical application and evaluation of the program
Scientific Title:Acronym Antenatal couple-based parenting support for preventing 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 prevent 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
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 Seiji
Middle name
Last name Yasumura
Organization Fukushima Medical University
School of Medicine
Division name Department of Public Health
Zip code 9601295
Address 1 Hikarigaoka, Fukushima, Japan
TEL 024-547-1180
Email yasumura@fmu.ac.jp

Public contact
Name of contact person
1st name Kayoko
Middle name
Last name Ishii
Organization Fukushima Medical University
Division name Radiation Medical Science Center
Zip code 9601295
Address 1 Hikarigaoka, Fukushima, Japan
TEL 024-547-1723
Homepage URL
Email kayokoi@fmu.ac.jp

Sponsor
Institute Department of Public Health
Fukushima Medical University
School of Medicine
Institute
Department

Funding Source
Organization Fukushima Medical University
School of Nursing
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 Fukushima Medical University
Address 1 Hikarigaoka, Fukushima, Japan
Tel 09019387374
Email 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
2016 Year 01 Month 29 Day

Related information
URL releasing protocol https://doi.org/10.1080/07399332.2019.1643350
Publication of results Partially published

Result
URL related to results and publications https://doi.org/10.1080/07399332.2019.1643350
Number of participants that the trial has enrolled 100
Results In total, 100 couples attended the program. Among 60 participating mothers, 20% screened positive for maternal depression symptoms. Changes in paternal empathy and maternal antenatal Edinburgh Postnatal Depression Scale score were significantly associated with maternal postpartum Edinburgh Postnatal Depression Scale score in multivariable analyses. Our results indicate that a key in preventing postpartum depression is paternal involvement and long-term support from antenatal phase.
Results date posted
2019 Year 08 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Participants were mother-father dyads. We excluded women in the first trimester (to focus on women in an obstetrically stable period) and those with no partner. The program was implemented at three sites with different management styles.
Participant flow At all three sites, we disseminated the program information widely. In total, 100 couples attended the program. We evaluated 95 couples after excluding 5 couples who declined to participate in the program evaluation. As a part of the program evaluation, we mailed self-administered questionnaires to couples at 6 weeks postpartum. We analyzed 60 couples that answered questionnaires after delivery.
Adverse events Nothing in particular
Outcome measures Edinburgh Postnatal Depression Scale (EPDS)
Face Scale
Perspective Taking component of the Multidimensional Empathy Scale.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2015 Year 11 Month 07 Day
Date of IRB
2015 Year 07 Month 28 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2016 Year 10 Month 08 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 01 Month 11 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 29 Day
Last modified on
2019 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022682

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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