UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039860 |
|---|---|
| Receipt number | R000045415 |
| Scientific Title | Reliability and Satisfaction Level of Telepsychiatric Assessments for Children with Neurodevelopmental Disorders (Autism Spectrum Disorders and Attention Deficit Hyperactivity Disorders) and Their Caregivers |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2022/08/30 10:08:16 |
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Basic information
Public title
Reliability and Satisfaction Level of Telepsychiatric Assessments for Children with Neurodevelopmental Disorders (Autism Spectrum Disorders and Attention Deficit Hyperactivity Disorders) and Their Caregivers
Acronym
Reliability and Satisfaction Level of Telepsychiatric Assessments for Children with Neurodevelopmental Disorders and Their Caregivers
Scientific Title
Reliability and Satisfaction Level of Telepsychiatric Assessments for Children with Neurodevelopmental Disorders (Autism Spectrum Disorders and Attention Deficit Hyperactivity Disorders) and Their Caregivers
Scientific Title:Acronym
Reliability and Satisfaction Level of Telepsychiatric Assessments for Children with Neurodevelopmental Disorders and Their Caregivers
Region
| Japan |
Condition
Condition
Children with Autism Spectrum Disorders:ASD, Attention-Deficit/Hyperactivity Disorders:ADHD, and their caregivers
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Reliability and Satisfaction Level of Tel
epsychiatric Assessments for Children
with Neurodevelopmental Disorders
(Autism Spectrum Disorders and Atte
ntion Deficit Hyperactivity Disorders)
and Their Caregivers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
comparison of scores in developmental assessment scales between face-to-face and online
Key secondary outcomes
satisfaction questionnaires for the use of tele-psychiatric assessment
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
| 17 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) An outpatient or hospitalized patient clinically diagnosed as ASD or ADHD, at Keio University Hospital or any joint research facilities (not excluding cases of coexisting ASD and ADHD)
2) Patients aged between 6 and 17 at the time of consent acquisition
3) Able to obtain consent from the Legal representative
4) If receiving any drug treatment, have been treated at a stable dose for at least 3 months prior to consent
Key exclusion criteria
1) Impairments in auditory or visual organs in either the patient or the caregiver, making it difficult to use remote tools despite adjustments using glasses or hearing aids.
2) No caregivers have information related to the patients' childhood
3) Research may be difficult due to psychiatric symptoms such as hallucinations
4) New treatments such as pharmacotherapy and psychotherapy are scheduled to start during the observation period
5) Interview assessments performed in this study may cause psychological and physical burden and worsen psychiatric symptoms.
6) Other reasons that investigators judge it is inappropriate to include into the study
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | Taishiro |
| Middle name | |
| Last name | Kishimoto |
Organization
Keio university school of medicine
Division name
Hills Joint Research Laboratory for Future Preventive Medicine and Wellnes
Zip code
106-0032
Address
Roppongi Hills North Tower 7F, 6-2-31 Roppongi, minato-ku, Tokyo, Japan
TEL
03-5786-0006
tkishimoto@keio.jp
Public contact
Name of contact person
| 1st name | Momoko |
| Middle name | |
| Last name | Kitazawa |
Organization
Keio University School of Medicine
Division name
Neuropsychiatric department
Zip code
106-0032
Address
35 Shinanomachi Shinjuku Tokyo
TEL
03-5363-3492
Homepage URL
m.kitazawa@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Program on Open Innovation Platform
with Enterprises, Reserch Institute and Academia(OPERA)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Review Subcommittee
Address
35 Shinanomachi Shinjuku Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.ac.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
慶應義塾大学病院（東京都）
東京都立小児総合医療センター（東京都）
島田療育センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Study design
Observational study
2. Recruitment
1) Outpatient or hospitalized patients clinically diagnosed as ASD or ADHD, at Keio University Hospital and other joint research facilities (will not exclude cases of coexisting ASD and ADHD)
2) Men and women aged between 6 and 17 at the time of consent acquisition
3) Obtain consent from the legal representative
4) When receiving drug treatment, have been treated at a stable dose for at least 3 months prior to consent
3.Outcomes
1) Main outcomes
Scores for the following developmental tests (face-to-face vs remote)
ADHD rating scale-IV
Childhood Autism Rating Scale-2 (CARS2)
4.Analysis
The outcomes of remote and face-to-face developmental tests are used as outcome indicators, and ICC is determined using age, gender, general intellectual function, and other background information that may affect developmental tests as covariates.
The degree of satisfaction obtained from the questionnaire is represented by an average value and a standard deviation.
Management information
Registered date
| 2020 | Year | 03 | Month | 18 | Day |
Last modified on
| 2022 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045415
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
