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 | 2025/11/24 09:46:57 |
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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
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
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
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
https://www.researchsquare.com/article/rs-38869/v1
Publication of results
Partially published
Result
URL related to results and publications
https://www.researchsquare.com/article/rs-38869/v1
Number of participants that the trial has enrolled
15
Results
Results: A comparison of the baseline scores and secondary outcomes reveals that the ADHD-RS total score and inattentive subscore worsened significantly during this period, whereas the hyper/impulsive subscore did not. In conclusion, we suggest that policymakers, healthcare providers and families should be mindful of the potential development of inattentiveness among children with ADHD who are quarantined because of COVID-19.
Results date posted
| 2025 | Year | 11 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Objective: The coronavirus disease 2019 pandemic has caused school closures worldwide. Japan's Prime Minister declared a state of emergency based on the coronavirus pandemic for Tokyo, Chiba, and other prefectures on April 7, 2020. Children with ADHD are particularly vulnerable to the distress caused by the pandemic and physical distancing measures, and they might display increased behavioral problems. We surveyed 15 children with ADHD, 13 were males and 2 were females (combined subtype, n=12; inattentive subtype, n=3). The children's ADHD-RS scores were assessed by their mother (n=12), father (n=1), or nursing home staff (n=2) from before the emergency declaration (in February or March 2020) to after the emergency declaration (April or May 2020). There were no changes of treating physician, drug type or quantity, or psychotherapy or assessment person from January 2020 to May 2020.
Participant flow
https://www.researchsquare.com/article/rs-38869/v1
Adverse events
No
Outcome measures
Baseline scores and secondary outcomes from before (February/March 2020) to after (April/May 2020) the April 7th emergency declaration in ADHD subjects
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
| 2025 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046085
