UMIN-CTR Clinical Trial

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
Email	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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045415