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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025803
Receipt No. 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

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

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
URL(English) https://upload.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


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