UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000022083
Receipt No. 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 (Ver. 4)

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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
Last 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
Email hhonda@shinshu-u.ac.jp

Public contact
1st 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
Email hhonda@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025448