UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of intervention program on improving work-life balance for working parents with pre-school child(ren): a pilot study (multi-institutional joint research)
Title of the study (Brief title)	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	Akihito Shimazu
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Mental Health
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	Akihito Shimazu
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Mental Health
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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