UMIN-CTR Clinical Trial

Basic information
Public title	Psychological and physical effects of self-isolation on Japanese school-aged children related to COVID19 epidemic
Acronym	Mental health on Japanese school-aged children related to COVID19 epidemic
Scientific Title	Psychological and physical effects of self-isolation on Japanese school-aged children due to COVID19 epidemic
Scientific Title:Acronym	Mental health on Japanese school-aged children related to COVID19 epidemic
Region	Japan

Condition
Condition	Post traumatic stress disorder, depression
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examinating the psychologicl and physical effects of Japanese school-aged children related to COVID19 epidemic
Basic objectives2	Others
Basic objectives -Others	Asking to self-isolating Japanese school-aged children to fill out the quality-of-life questionnaire and five well-being index.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Five well-being index (WHO-5)
Key secondary outcomes	Quality-of-life questionnaire

Base
Study type	Observational

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	7 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	All elementary and middle school children who come to our outpatient clinic
Key exclusion criteria	Excluding the children who do not wish to attend this study, nor who do not answer the questionnaires
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Mari Middle name Last name Saito
Organization	Haga Red Cross Hospital
Division name	Pediatrics
Zip code	3214306
Address	271 Nakagou, Mouka, Tochigi
TEL	0285822195
Email	mari.saito@haga.jrc.or.jp

Public contact
Name of contact person	1st name Mari Middle name Last name Saito
Organization	Haga Red Cross Hospital
Division name	Pediatrics
Zip code	3214306
Address	271 Nakago Mouka Tochigi
TEL	0285822195
Homepage URL
Email	mari.saito@haga.jrc.or.jp

Sponsor
Institute	Haga Red Cross Hospital
Institute
Department

Funding Source
Organization	Pediatrics reserach funding in Haga Red Cross Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Haga Red Cross Hospital Ethics Committee
Address	271 Nakago Mouka Tochigi
Tel	0285822195
Email	mari.saito@haga.jrc.or.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	R2-10
Org. issuing International ID_1	Haga Red Cross Hospital Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 11 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	2020 Year 05 Month 10 Day
Date of IRB	2020 Year 05 Month 10 Day
Anticipated trial start date	2020 Year 05 Month 10 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	At the end of the self-isolation period, we will analyze the questionnaire, WHO-5 and other related data.

Management information
Registered date	2020 Year 05 Month 10 Day
Last modified on	2020 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046043

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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