UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055017 |
|---|---|
| Receipt number | R000062857 |
| Scientific Title | Research on "Building a social system based on the formation of parent-child attachment that leads to child development" (for researchers) |
| Date of disclosure of the study information | 2024/07/20 |
| Last modified on | 2025/01/17 11:10:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research on "Building a social system based on the formation of parent-child attachment that leads to child development" (for researchers)
Acronym
Research on "Building a social system based on the formation of parent-child attachment that leads to child development" (for researchers)
Scientific Title
Research on "Building a social system based on the formation of parent-child attachment that leads to child development" (for researchers)
Scientific Title:Acronym
Research on "Building a social system based on the formation of parent-child attachment that leads to child development" (for researchers)
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As part of the social implementation of parenting support initiatives aimed at children and parents, based on the Interaction Rating Scale (IRS)(*1), we will conduct research with the following objectives.
- The purpose of this research is to have researchers with specialized knowledge conduct a pre-evaluation of the solution provided, focusing on its usability, to see if there are any operational issues or areas for improvement, before evaluating the concept for general households.
- Usability refers to the operability and operation of the system provided.
- After taking measures to address the issues extracted in this research, we plan to conduct an evaluation for general households next year.
(*1) Interaction Rating Scale: An index developed as a method of measuring various aspects of social competence from infancy to adulthood, in a scenario with ecological validity, with high accuracy and ease, in a form that is internationally comparable.
Basic objectives2
Others
Basic objectives -Others
Acceptability test
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A web survey (Likert scale method) to confirm the following items:
- User interface: Operability of the system provided, video shooting procedures, etc.
- Content of message presented: Improvements to the message presented, etc.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The research subjects will be observed and filmed for approximately five minutes as they work on the task.
The researcher will conduct an IRS evaluation based on the results of the observations and recordings, and will send the research subjects a message based on the results of the IRS evaluation.
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
| 1 | years-old | <= |
Age-upper limit
| 3 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study is aimed at staff at research institutions who have children aged 1 to 3 years old.
Key exclusion criteria
No
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Udagawa |
Organization
Asahi Kasei Corporation
Division name
Business Strategy Promotion Dept. Digital Strategy Initiative Digital Value Co-Creation
Zip code
108-0023
Address
msb Tamachi - Tamachi Station Tower N 14F, 3-1-1 Shibaura, Minato-ku, Tokyo
TEL
080-9023-6557
udagawa.kb@om.asahi-kasei.co.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Kitahara |
Organization
Asahi Kasei Corporation
Division name
Business Strategy Promotion Dept. Digital Strategy Initiative Digital Value Co-Creation
Zip code
108-0023
Address
msb Tamachi - Tamachi Station Tower N 14F, 3-1-1 Shibaura, Minato-ku, Tokyo
TEL
070-2460-1948
Homepage URL
kitahara.yf@om.asahi-kasei.co.jp
Sponsor or person
Institute
Asahi Kasei Corporation
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Asahi Kasei Corporation
Address
Hibiya Mitsui Tower, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo
Tel
03-6699-3000
harada.yv@om.asahi-kasei.co.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
| 2024 | Year | 07 | Month | 20 | 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
15
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
Completed
Date of protocol fixation
| 2024 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 19 | Day |
Last modified on
| 2025 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062857
