UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020790
Receipt number 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 09:47:28

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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 or person

Institute

Department of Public Health
Fukushima Medical University
School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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