UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025803
Receipt number R000029664
Scientific Title Development of intervention program on improving work-life balance for working parents with pre-school child(ren): a pilot study (multi-institutional joint research)
Date of disclosure of the study information 2017/01/23
Last modified on 2017/01/23 15:51:26

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Basic information

Public title

Development of intervention program on improving work-life balance for working parents with pre-school child(ren): a pilot study (multi-institutional joint research)

Acronym

TWIN study

Scientific Title

Development of intervention program on improving work-life balance for working parents with pre-school child(ren): a pilot study (multi-institutional joint research)

Scientific Title:Acronym

TWIN study

Region

Japan


Condition

Condition

Working parents with pre-school child(ren)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to develop a program to improve work-life balance for working parents with pre-school child(ren) and to examine the effectiveness.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Work life balance (SWING-J)

Key secondary outcomes

1) Perceived social support
2) Work engagement
3) Parenting stress
4) Sleeping state
5) Self-efficacy of Work life balance
6) Mental health


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

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Participants take programs that aim at improving work-life balance. Programs provide knowledge and skills on stress management, communication, career plans, and child care.

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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1) Working Men and women
2) Having a pre-school child(ren)

Key exclusion criteria

1) Person who taking childcare leave

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akihito Shimazu

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Mental Health

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

+81-3-5841-3612

Email

ashimazu@m.u-tokyo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akihito Shimazu

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Mental Health

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

+81-3-5841-3612

Homepage URL

http://wlb.umin.jp/

Email

ashimazu@m.u-tokyo.ac.jp


Sponsor or person

Institute

Department of Mental Health, Graduate School of Medicine, The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Japan socierty for the promotion of science

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2017 Year 01 Month 23 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

2016 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 17 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 01 Month 23 Day

Last modified on

2017 Year 01 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029664


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name