UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on development of the child born in a year of the Great East Japan Earthquake-Association with the mental and physical health condition of parents-
Title of the study (Brief title)	Study on development of the child born in a year of the Great East Japan Earthquake
Region	Japan

Condition
Condition	Mental and physical health condition ( parents) Development of the mind and body (children)
Classification by specialty	Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Inventory survey study
Basic objectives2	Others
Basic objectives -Others	Inventory survey study
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The mental health of parents is related to the development of the child GHQ28, Japanese edition Denver developmental screening test
Key secondary outcomes	The number of the movement of the house.

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	22 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Mather and father of the child born in a year of the Great East Japan Earthquake
Key exclusion criteria	Mather and father that Japanese can not understand and write
Target sample size	200

Research contact person
Name of lead principal investigator	Kineko Sato
Organization	Tohoku University Graduate School of Medicine
Division name	Maternal Nursing
Address	2-1 Seiryo-machi,Aoba-ku,Sendai-shi#981-8575,Japan
TEL	022-717-7956
Email	satokine@med.tohoku.ac.jp

Public contact
Name of contact person	Kineko Sato
Organization	Tohoku University Graduate School of Medicine
Division name	Maternal Nursing
Address	2-1 Seiryo-machi,Aoba-ku,Sendai-shi#981-8575,Japan
TEL	022-717-7956
Homepage URL
Email	satokine@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2016 Year 06 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 23 Day
Anticipated trial start date	2016 Year 06 Month 15 Day
Last follow-up date
Date of closure to data entry	2016 Year 10 Month 01 Day
Date trial data considered complete	2016 Year 10 Month 31 Day
Date analysis concluded	2017 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	An analyzed result is announced to a related academic meeting.

Management information
Registered date	2016 Year 06 Month 06 Day
Last modified on	2018 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026076