UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000053355
Receipt number R000060899
Scientific Title Development of an online prenatal coparenting program for new parents and evaluation of changes; A feasibility study.
Date of disclosure of the study information 2024/01/15
Last modified on 2024/07/16 09:15:43

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Basic information

Public title

Development of an online prenatal coparenting program for new parents and evaluation of changes; A feasibility study.

Acronym

Development of an online prenatal coparenting program for new parents and evaluation of changes; A feasibility study.

Scientific Title

Development of an online prenatal coparenting program for new parents and evaluation of changes; A feasibility study.

Scientific Title:Acronym

Development of an online prenatal coparenting program for new parents and evaluation of changes; A feasibility study.

Region

Japan


Condition

Condition

Pregnancy

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To develop an online programme to promote prenatal co-parenting for new parents and to identify changes in prenatal co-parenting, attachment to the foetus, relationship perceptions and communication between couples, preparations to work together and parenting readiness.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Prenatal coparenting

Key secondary outcomes

Attachment to the foetus,Couple relationships perception,Communication between couples, Preparations to parenting together,Parenting readiness.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Participate an online prenatal coparenting program.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Couples whom gestational age must be 24-33weeks, both parents must be first-time parents, both parents must be able to participate in this study, .the pregnant woman and foetus must be free from complications that may be life-threatening to the life expectancy,they can access to the internet.

Key exclusion criteria

Couples, including pregnant women whose mental illness is interfering with their daily life to the extent that they require specialised treatment and care.

Target sample size

42


Research contact person

Name of lead principal investigator

1st name NATSUKO
Middle name
Last name KOJIMA

Organization

Tokyo Healthcare University

Division name

Higashigaoka Faculty of Nursing

Zip code

152-8558

Address

2-5-1 Higashigaoka, Meguro-ku, Tokyo

TEL

0357795031

Email

n-kojima@thcu.ac.jp


Public contact

Name of contact person

1st name Natusko
Middle name
Last name Kojima

Organization

Tokyo Healthcare University

Division name

Higashigaoka Faculty of Nursing

Zip code

152-8558

Address

2-5-1 Higashigaoka, Meguro-ku, Tokyo

TEL

0357795031

Homepage URL


Email

n-kojima@thcu.ac.jp


Sponsor or person

Institute

Tokyo Healthcare University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Healthcare University

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

Tokyo Healthcare University

Address

4-1-17 Higashigotanda, Shinagawa-ku, Tokyo

Tel

0354217685

Email

kenkyo@thcu.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

2024 Year 01 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Enrolling by invitation

Date of protocol fixation

2024 Year 01 Month 15 Day

Date of IRB

2024 Year 02 Month 15 Day

Anticipated trial start date

2024 Year 04 Month 01 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2024 Year 01 Month 15 Day

Last modified on

2024 Year 07 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060899