UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040476
Receipt number 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 2023/07/03 13:53:59

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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 or person

Institute

Chiba University

Institute

Department

Personal name



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

2023 Year 12 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

2023 Year 07 Month 03 Day



Link to view the page

Value
https://center6.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