UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033677
Receipt No. R000030290
Official scientific title of the study 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Promoting father's child rearing behaviors and preventing paternal and maternal postpartum depression: evaluation of the antenatal couple-based parenting support program
Title of the study (Brief title) 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 Seiij Yasumura
Organization Fukushima Medical University
School of Medicine
Division name Department of Public Health
Address 1 Hikarigaoka, Fukushima, Japan
TEL 024-547-1180
Email yasumura@fmu.ac.jp

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

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

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 04 Month 13 Day
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

Related information
URL releasing protocol
Publication of results Published
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030290

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.