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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040476
Receipt No. R000046085
Scientific Title Clinical record investigation about ADHD children before and after the emergency declaration because of COVID19
Date of disclosure of the study information 2020/05/21
Last modified on 2020/05/21

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Basic information
Public title Clinical record investigation about ADHD children before and after the emergency declaration because of COVID19
Acronym Clinical record investigation about ADHD children because of COVID19
Scientific Title Clinical record investigation about ADHD children before and after the emergency declaration because of COVID19
Scientific Title:Acronym Clinical record investigation about ADHD children because of COVID19
Region
Japan

Condition
Condition Attention-Deficit/Hyperactivity Disorder: AD/HD
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the relations of the symptom change of ADHD children before and after the emergency declaration with the COVID-19 epidemicity.
Basic objectives2 Others
Basic objectives -Others To help treatment and evaluation of ADHD children for the future infectious disease epidemicity, emergency declaration.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The change of ADHD-RS (total score) of from February to March in 2020 (before emergency declaration) and from April to May in 2020 (after emergency declaration).
Key secondary outcomes The change of ADHD-RS (inattentive subscore and hyper / impulsive subsocore) of from February to March in 2020 (before emergency declaration) and from April to May in 2020 (after emergency declaration).

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
6 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria (1) The patients of Chiba university hospital diagnosed as ADHD (DSM-5)

(2) Children with ADHD of an elementary and junior high school, the high school student in Chiba Japan (from 6 years old 18 years old)

(3) No changes of physician, drug type and quantity, psychotherapy and assessment person of ADHD-RS. (from January 2020 to May 2020.)


Key exclusion criteria Not equal to inclusion criteria.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Masaomi
Middle name
Last name Iyo
Organization Graduate School of Medicine, Chiba University
Division name Department of Psychiatry
Zip code 2608670
Address 1-8-1 Inohana, Chuo-ku, Chiba
TEL 043-222-7171
Email iyom@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Tsuyoshi
Middle name
Last name Sasaki
Organization Chiba-University Hospital
Division name Department of Child Psychiatry
Zip code 2608670
Address 1-8-1 Inohana, Chuo-ku, Chiba
TEL 043-222-7171
Homepage URL
Email sasaki@faculty.chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Chiba University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The ethics committee of Chiba University Graduate School of Medicine
Address 1-8-1 Inohana, Chuo-ku, Chiba
Tel 043-222-7171
Email igaku-rinri@chiba-u.jp

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
2020 Year 05 Month 21 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 11 Day
Date of IRB
2020 Year 05 Month 21 Day
Anticipated trial start date
2020 Year 05 Month 21 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study from before declaration of emergency (February or March, 2020) to after declaration of emergency (April or May, 2020) in ADHD children.

Management information
Registered date
2020 Year 05 Month 21 Day
Last modified on
2020 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046085

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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