UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051332 |
|---|---|
| Receipt number | R000058555 |
| Scientific Title | Developing a computer-adaptive screening test of child and adolescent psychiatric diseases |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2023/06/13 17:50:47 |
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Basic information
Public title
Developing a computer-screening of child mental health
Acronym
Developing the C-CAT
Scientific Title
Developing a computer-adaptive screening test of child and adolescent psychiatric diseases
Scientific Title:Acronym
Developing the C-CAT
Region
| Japan |
Condition
Condition
child and adolescent mental disorders
Classification by specialty
| Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This research aims to develop a CAT easily accessible that is designated for most common mental disorders in children and adolescents.
Basic objectives2
Others
Basic objectives -Others
In order to address the problem of child and adolescent mental disorders being underidentified screening instruments are needed to help identify the disorders with high accuracy and to aid facilitating access to specialized care. A computer-adaptive test (CAT) based on an item-response theory is such a screening test most feasible at present. This research aims to develop a CAT easily accessible that is designated for most common mental disorders in children and adolescents.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Criterion validity: area under the ROC curve (AUC) for the gold-standard diagnosis
Construct validity: correlation coefficients with external questionnaire scores
Test--retest reliability: intraclass correlation coefficients
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 6 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) aged 6 to 18 years
2) Japanese-speaking psychiatric patients or healthy children whose legal guardians are also Japanese speakers.
3) participants or their parents with written informed consent
Key exclusion criteria
1)patients with physical illnesses requiring urgent treatment (e.g., severe anorexia nervosa)
2)partipants whose parents or caregivers cannot communicate appropriately (e.g.,due to mental retardation)
3)when the investigators determine that inclusion to the study is not appropriate for other reasons
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nishiyama |
Organization
Nagoya City University Graduate School of Medicine
Division name
Department of Public Health
Zip code
467-8601
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
0528538176
p-gen@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Nishiyama |
Organization
Nagoya City University Graduate School of Medicine
Division name
Department of Public Health
Zip code
467-8601
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
0528538176
Homepage URL
p-gen@umin.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Takeshi Nishiyama
Funding Source
Organization
none
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
Clinical Research Management Center, Nagoya City University Hospital
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Japan
Tel
052-858-7215
clinical_research@med.nagoya-cu.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
名古屋市立大学病院（愛知県），名古屋大学医学部附属病院（愛知県），福井大学病院（福井県），上林記念病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 01 | 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 | 03 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
nothing special
Management information
Registered date
| 2023 | Year | 06 | Month | 13 | Day |
Last modified on
| 2023 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058555
