UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050198 |
|---|---|
| Receipt number | R000057160 |
| Scientific Title | Attachment formation study of ASD by animal robots |
| Date of disclosure of the study information | 2023/01/31 |
| Last modified on | 2023/08/31 09:48:32 |
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Basic information
Public title
Exploratory research on the possibility of attachment formation in infants with autism spectrum disorder using an animal robot (new type aibo)
Acronym
Attachment formation study of ASD by animal robots
Scientific Title
Attachment formation study of ASD by animal robots
Scientific Title:Acronym
Attachment formation study of ASD by animal robots
Region
| Japan |
Condition
Condition
autistic spectrum disorder
Classification by specialty
| Pediatrics | Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Attachment potential
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in contact and play with aibo between high ASD trait group and low ASD trait group
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
High ASD group play with animal robots for 10 minutes
Interventions/Control_2
Low ASD group play with animal robots for 10 minutes
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
| 4 | years-old | <= |
Age-upper limit
| 8 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
HighASD
Children between the ages of 4 and 8
FIQ 70 or higher in the intelligence test Tanaka Binet or WISC .
Children diagnosed with autism spectrum disorder according to the American Medical Association diagnostic criteria DSM5
A score of 20 or higher on the Autism Spectrum Disorder Scale AQJ Children's Edition
Children who have obtained written consent from their legal representatives and have obtained consent to participate in this study from the subject himself/herself
Children who applied at a university hospital
LowASD
Children between the ages of 4 and 8
FIQ 70 or higher in the intelligence test Tanaka Binet or WISC.
Children diagnosed with autism spectrum disorder according to the American Medical Association diagnostic criteria DSM 5
Autism Spectrum Disorder Scale of AQJ Children's version of 19 points or less
Children who have obtained written consent from their legal representatives and have obtained consent to participate in this study from the subject
Children who applied at a university hospital
Key exclusion criteria
Infants judged inappropriate by the attending physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | kazuya |
| Middle name | |
| Last name | ono |
Organization
St Marianna University of Medicine
Division name
Neuropsychiatry
Zip code
216-8511
Address
2-16-1 sugao miyamae-ku kawasaki city kanagawa
TEL
044-977-8111
kazuya.ono@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | kazuya |
| Middle name | |
| Last name | ono |
Organization
St Marianna University of Medicine
Division name
Neuropsychiatry
Zip code
216-8511
Address
2-16-1 sugao miyamae-ku kawasaki city kanagawa
TEL
044-977-8111
Homepage URL
kazuya.ono@marianna-u.ac.jp
Sponsor or person
Institute
St Marianna University of Medicine
Institute
Department
Personal name
kazuya ono
Funding Source
Organization
St Marianna University of Medicin
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
St. Marianna University School of Medicine Bioethics Committee Clinical Trial Subcommittee202
Address
2-16-1 sugao miyamae-ku kawasaki city kanagawa
Tel
044-977-8111
k-sienbu.mail@marianna-u.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
聖マリアンナ医科大学付属病院(神奈川県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 31 | Day |
Last modified on
| 2023 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057160
| Research Plan | |
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| 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 |
