UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051735 |
|---|---|
| Receipt number | R000058289 |
| Scientific Title | Research on the construction of a remote consultation system for children with autism spectrum disorder (ASD) and their parents |
| Date of disclosure of the study information | 2023/07/28 |
| Last modified on | 2023/07/28 09:52:27 |
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Basic information
Public title
Research on the construction of a remote consultation system for children with autism spectrum disorder (ASD) and their parents
Acronym
Research on the construction of a remote consultation system for children with ASD and their parents
Scientific Title
Research on the construction of a remote consultation system for children with autism spectrum disorder (ASD) and their parents
Scientific Title:Acronym
Research on the construction of a remote consultation system for children with ASD and their parents
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effect of providing remote developmental counseling to the families of infants with suspected autism spectrum disorder (ASD) who tested positive for M-CHAT at the infant health examination and require follow-up observation, and to examine the feasibility of implementing a system in which the results of remote developmental counseling are shared with local governments and lead to consultations at medical institutions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from Baseline to 3 Months for Total Parenting Stress Index SF Score
Key secondary outcomes
Change from baseline to 3 months in total WHO-5 (Mental Health Status Chart, simplified version) score
Change from baseline to 3 months for the child dimension of the Parenting Stress Index SF
Change from baseline to 3 months in the parental aspect of the Child Care Stress Index SF
The number of children who were connected to the community health center or medical institution in the municipality after the infant health checkup that required observation, compared to the previous year.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
After consent is confirmed, an appointment for remote consultation will be obtained and one one-hour remote developmental consultation will be used (baseline). The "developmental consultation" in this study is a response to developmental consultation from parents by a physician or psychologist with knowledge of child psychiatry, who is a co-researcher, and no medical treatment, diagnosis, or developmental examination is conducted. The content of the consultation will be shared by the responding physician or psychologist with the public health nurses of the local government after the consultation. This information is shared in writing and orally (online) as necessary after the completion of the remote developmental consultation.
The specific contents of the online consultation are as follows.
The parents are asked what they consider to be the problems in their children's development, how they are responding to their children's behavior, and how their children are reacting to their behavior.
To think together with the parents about how to respond and cope with the child's development and characteristics.
Talk about the parent-child relationship and the future (results of the questionnaire)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. parents or guardians of children who have undergone M-CHAT at the infant health examination and who require follow-up care
2. those who agree with the content of this study and give their consent to participate in the study
3. Those who have Internet access at home and can use the remote developmental counseling service via Internet connection throughout the study period.
4. who can understand the Japanese language described in the consent document and questionnaires.
Key exclusion criteria
1. those who require a surrogate
2. who are undergoing treatment for a physical or mental illness and for whom treatment should be prioritized over consultation for this study
3. who are otherwise deemed inappropriate to participate in this study by the principal investigator or research coordinator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Tachibana |
Organization
National Center for Child Health and Development
Division name
Hospital
Zip code
157-8535
Address
2-10-1 Okura Setagaya-ku Tokyo
TEL
03-5494-7120
tachibana-y@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Tachibana |
Organization
National Center for Child Health and Development
Division name
Hospital
Zip code
157-8535
Address
2-10-1 Okura Setagaya-ku Tokyo
TEL
03-5494-7120
Homepage URL
tachibana-y@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Child Health and Development Ethics Review Committee Secretariat
Address
2-10-1 Okura Setagaya-ku Tokyo
Tel
03-5494-7243
rinri@ncchd.go.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
| 2023 | Year | 07 | Month | 28 | 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 | 02 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 01 | 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 | 07 | Month | 28 | Day |
Last modified on
| 2023 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058289
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
