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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039860
Receipt No. 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 2020/04/24

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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 Neuropsychiatric department
Zip code 160-8582
Address Shinjuku-ku
TEL 0333531211
Email tkishimoto@keio.jp

Public contact
Name of contact person
1st name Kitazawa
Middle name
Last name Momoko
Organization Keio University School of Medicine
Division name Neuropsychiatric department
Zip code 160-8582
Address 35 Shinanomachi Shinjuku Tokyo
TEL 0333531211
Homepage URL
Email m.kitazawa@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
Email 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 Enrolling by invitation
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
2020 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045415

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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