UMIN-CTR Clinical Trial

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