UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040172
Receipt number R000045750
Scientific Title Internet-based, randomized, 28weeks (from 28th weeks of pregnancy to 100 days after childbirth) intervention, parallel-group, superiority study to compare the efficacy of text messaging (NCNP kizuna mail) group to non-intervention group for father's mental health assessed by the General Health Questionnaire-12 (GHQ12)
Date of disclosure of the study information 2020/04/16
Last modified on 2024/03/18 10:31:47

* 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

Public title

Internet-based, randomized, 28weeks (from 28th weeks of pregnancy to 100 days after childbirth) intervention, parallel-group, superiority study to compare the efficacy of text messaging (NCNP kizuna mail) group to non-intervention group for father's mental health assessed by the General Health Questionnaire-12 (GHQ12)

Acronym

Randomized Controlled Trial of Text messaging for Perinatal Mental Health of Fathers

Scientific Title

Internet-based, randomized, 28weeks (from 28th weeks of pregnancy to 100 days after childbirth) intervention, parallel-group, superiority study to compare the efficacy of text messaging (NCNP kizuna mail) group to non-intervention group for father's mental health assessed by the General Health Questionnaire-12 (GHQ12)

Scientific Title:Acronym

Randomized Controlled Trial of Text messaging for Perinatal Mental Health of Fathers

Region

Japan


Condition

Condition

Paternal depression and anxiety

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This clinical trial aimed to test the efficacy of the text messaging (NCNP kizuna mail) to perinatal fathers and mothers against non-intervention on the General Health Questionnaire-12 (GHQ-12) of fathers at 100 days after childbirth.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase III


Assessment

Primary outcomes

Mental health condition of fathers assessed by the General Health Questionnaire-12 (GHQ-12) at 100 days after childbirth

Key secondary outcomes

The proportion of the high score in the General Health Questionnaire-12 (GHQ-12) at 100 days after childbirth
The total score of the Satisfaction of Husband and wife's relationships Scale at 100 days after childbirth
The total score of the Japanese version of the Survey Work-home Interaction at 100 days after childbirth
The total score of the Childcare Emotion Scale at 100 days after childbirth


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

text messaging (NCNP kizuna mail) to expectant mothers and fathers
Our text messaging consists of information about the prenatal mother's health condition, development of embryo and infant, tips for child care, self-care and partnership. All contents are supervised by obstetricians, pediatricians, and psychiatrists. The length of the text message is from 150 to 450 characters (written in Japanese), and the contents are adjusted to week numbers in pregnancy. Participants receive the text message every day from 28th weeks of pregnancy to 100 days after childbirth. Some of the text messages contain URL of a website which provides potentially useful information to parents in the perinatal period (knowell family; https://www.ncnp.go.jp/cbt/knowell/).

Interventions/Control_2

no intervention

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Expectant parents with ages 20 years or older at baseline, and from 14th weeks to 28th weeks of pregnancy
2) Participants who give full consent in the participation of the study
3) Participants who can join with one's partner
4) Participants who can understand Japanese
5) Participants who have a mobile phone

Key exclusion criteria

none

Target sample size

450


Research contact person

Name of lead principal investigator

1st name Aiichiro, Ayako
Middle name
Last name Nakajima, Kanie

Organization

National Center of Neurology and Psychiatry

Division name

National Center of Cognitive-Behavior Therapy and Research

Zip code

187-8551

Address

Kodaira, Tokyo, Japan, 187-8551

TEL

+81-42-341-2712(3341.3087)

Email

aiichiro.nakajima@ncnp.go.jp


Public contact

Name of contact person

1st name Aiichiro
Middle name
Last name Nakajima

Organization

National Center of Neurology and Psychiatry

Division name

National Center of Cognitive-Behavior Therapy and Research

Zip code

187-8551

Address

Kodaira, Tokyo, Japan, 187-8551

TEL

+81-42-341-2712(3341)

Homepage URL


Email

aiichiro.nakajima@ncnp.go.jp


Sponsor or person

Institute

National Center of Neurology and Psychiatry, Japan

Institute

Department

Personal name



Funding Source

Organization

KAKENHI Grant-in-aid for young scientists

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kizunamail Project (Nonprofit Organization)

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board at National Center of Neurology and Psychiatry

Address

Kodaira, Tokyo, Japan, 187-8551

Tel

+81-42-341-2711

Email

rinri-jimu@ncnp.go.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

2020 Year 04 Month 16 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

Completed

Date of protocol fixation

2019 Year 12 Month 01 Day

Date of IRB

2020 Year 02 Month 13 Day

Anticipated trial start date

2020 Year 04 Month 17 Day

Last follow-up date

2021 Year 04 Month 30 Day

Date of closure to data entry

2021 Year 12 Month 31 Day

Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded

2022 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2020 Year 04 Month 15 Day

Last modified on

2024 Year 03 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045750


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name