UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051729 |
|---|---|
| Receipt number | R000057014 |
| Scientific Title | Research on the construction of a remote consultation system for young children with suspected autism spectrum disorder and their parents |
| Date of disclosure of the study information | 2023/07/27 |
| Last modified on | 2023/07/28 09:43:54 |
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Basic information
Public title
Research on the construction of a remote consultation system for young children with suspected autism spectrum disorder and their parents
Acronym
Research on the construction of a remote consultation system for young children with suspected ASD and their parents
Scientific Title
Research on the construction of a remote consultation system for young children with suspected autism spectrum disorder and their parents
Scientific Title:Acronym
Research on the construction of a remote consultation system for young children with suspected ASD and their parents
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effect of providing developmental counseling to ASD patients and their families using an existing remote counseling system to improve the quality of life of parents in raising ASD children, and to study the feasibility of implementing this service.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline to 3 months in total Parenting Stress Index Short Form (PSI-SF) score for intervention and control groups
Key secondary outcomes
Change from baseline to 3 months in WHO-5 total score (intervention and control groups)
Change from baseline to 3 months in the PSI-SF Child Aspects (intervention and control groups)
Change from baseline to 3 months for the parental dimension of the PSI-SF (intervention and control groups)
Change in PSI-SF total score at 3 and 6 months (intervention and control groups)
Change in WHO-5 total score at 3 and 6 months (intervention and control groups)
Change in PSI-SF Child Aspects at 3 and 6 months (intervention and control groups)
Change in PSI-SF Parent Aspects at 3 and 6 months (intervention and control groups)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
After consent is confirmed, the intervention group will be sent the URL for downloading the Online Medical Pocket Doctor to their own smartphones before the intervention is conducted. The intervention group will continue to use the developmental consultation service, which will be provided 21 times a month for about 30 minutes per session for a period of 3 months, using the application dedicated to the Online Medical Consultation Pocket Doctor. The "developmental consultation" in this study is a response to developmental consultations from parents by a physician with knowledge of child psychiatry, a psychologist, or a rehabilitation specialist, who is a co-researcher, and does not provide medical treatment, diagnosis, or developmental testing.
The specific content of the online consultation is as follows
First session: Listening to and evaluating what the parents have to say (results of assessment sheets and questionnaires)
Second session: Gather information on the development of the child of concern (current situation of the parents/caregivers and parents/children, understanding of the child's development) and find out what the parents are having trouble with and what they perceive as problems in their child's development.
Session 3: To understand children's development and characteristics by asking parents how they respond to their children's behavior and how their children react to it, and to think about how to respond and cope with it together with the parents.
Session 4: Summary, the need for parent-child relationships and connections with medical institutions and rehabilitation institutions, and the future (results of the questionnaire)
Interventions/Control_2
The control group receives only general community support for children with ASD or suspected ASD.
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 with preschool children who are members of the Society for Physical Activity and Rehabilitation of Children in Japan (SPARK Association) and who have confirmed that they meet the criteria for ASD
For children who have not been diagnosed with ASD at a medical institution, a physician qualified as a psychiatrist by the Japanese Neuropsychiatric Association or a pediatrician by the Japanese Pediatric Society at the time of consent is obtained, and a psychiatrist or pediatrician qualified as a specialist in the diagnosis criteria of the American Psychiatric Association, Diagnostic Determine if the criteria for ASD can be confirmed to be met based on the Diagnostic Statistical Manual-5 (DSM-5), the diagnostic criteria of the American Psychiatric Association
2. agree with the content of the study and give their consent to participate in the study
3. have access to the Online Medical Pocket Doctor via Internet connection throughout the study period or agree to participate in the study using the Online Medical Pocket Doctor on a smartphone that will be loaned to them
4. who can download and use the dedicated application for Online Doctor Pocket Doctor on their own smartphone
5. who can understand the Japanese language described in the consent document and questionnaire
Key exclusion criteria
1. those who require a surrogate
2. who are undergoing treatment for psychiatric disorders and for whom psychiatric 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 the Principal Investigator
Target sample size
40
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 | 27 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 27 | 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 | 07 | Month | 27 | 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=R000057014
| 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 |
