UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022627 |
|---|---|
| Receipt number | R000026076 |
| Scientific Title | 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- |
| Date of disclosure of the study information | 2016/06/20 |
| Last modified on | 2018/06/21 18:33:53 |
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Basic information
Public title
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-
Acronym
Study on development of the child born in a year of the Great East Japan Earthquake
Scientific Title
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-
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kineko Sato |
Organization
Tohoku University Graduate School of Medicine
Division name
Maternal Nursing
Zip code
Address
2-1 Seiryo-machi,Aoba-ku,Sendai-shi#981-8575,Japan
TEL
022-717-7956
satokine@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kineko Sato |
Organization
Tohoku University Graduate School of Medicine
Division name
Maternal Nursing
Zip code
Address
2-1 Seiryo-machi,Aoba-ku,Sendai-shi#981-8575,Japan
TEL
022-717-7956
Homepage URL
satokine@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2016 | Year | 05 | Month | 23 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026076
