UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022083 |
|---|---|
| Receipt number | R000025448 |
| Scientific Title | A study on the inter-rater reliability of a comprehensive screening tool for neurodevelopmental disorders and maltreatment in preschool children |
| Date of disclosure of the study information | 2016/04/26 |
| Last modified on | 2019/04/29 10:31:34 |
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Basic information
Public title
A study on the inter-rater reliability of a comprehensive screening tool for neurodevelopmental disorders and maltreatment in preschool children
Acronym
A study on the inter-rater reliability of a screening tool for preschool children
Scientific Title
A study on the inter-rater reliability of a comprehensive screening tool for neurodevelopmental disorders and maltreatment in preschool children
Scientific Title:Acronym
A study on the inter-rater reliability of a screening tool for preschool children
Region
| Japan |
Condition
Condition
neurodevelopmental disorders and maltreatment
Classification by specialty
| Pediatrics | Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to investigate inter-rater reliability of screening tools for 18-month-old children and for 2-year-old children to detect neurodevelopmental disorders and maltreatment.
Basic objectives2
Others
Basic objectives -Others
To investigate rate of screening positive and inter-rater reliability for each item.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
inter-rater reliability for each item
Key secondary outcomes
rate of screening positive for each item
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
screening procedure taking about 10 minutes in which an examiner talks to a child or ask a child to play using tools such as toys
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
| 18 | months-old | <= |
Age-upper limit
| 25 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
children of 18-19 months old and children of 24-25 months old attending nursery schools in Yamanashi Prefecture, Japan
Key exclusion criteria
1. children with visual impairment
2. children with hearing impairment
3. children with impairment of motor function
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Honda |
Organization
Shinshu University Hospital
Division name
Mental Health Clinic for Children
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-3060
hhonda@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideo |
| Middle name | |
| Last name | Honda |
Organization
Shinshu University Hospital
Division name
Mental Health Clinic for Children
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-3060
Homepage URL
hhonda@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Independent Ethics Committee
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263-37-2572
mdrinri@shinshu-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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000022083
Publication of results
Unpublished
Result
URL related to results and publications
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000022083
Number of participants that the trial has enrolled
57
Results
A new screening tool was developed to systematically screen children with either neurodevelopmental disorders or mental disorders by maltreatment, and inter-rater reliability of some items of the tool was investigated. 25 children participated in the test for 18-month-old children, and 32 in the test for 2-year-old children. Two raters independently tested the children at an hour interval and calculated kappa for each item.
Results date posted
| 2019 | Year | 04 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty-five 18-month-old children and 32 2-year-old children at nursery schools
Participant flow
The test using the tool was executed for 18-month-old children and 2-year-old children who belong to nursery schools in Yamanashi Prefecture, and with informed assent by their parents.
Adverse events
None
Outcome measures
inter-rater reliability
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 05 | 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
| 2016 | Year | 04 | Month | 26 | Day |
Last modified on
| 2019 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025448
| 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 |
