UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059265 |
|---|---|
| Receipt number | R000066919 |
| Scientific Title | Cohort Study in Okaya City, Nagano Prefecture: Relationship between Maternal and Child Health Information and Mental Health Status in the Sixth and Ninth Grades |
| Date of disclosure of the study information | 2025/10/05 |
| Last modified on | 2025/10/02 10:38:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Cohort Study in Okaya City, Nagano Prefecture: Relationship between Maternal and Child Health Information and Mental Health Status in the Sixth and Ninth Grades
Acronym
Okaya Cohort Study: Relationship between Maternal and Child Health Information and Children's Mental Health Status
Scientific Title
Cohort Study in Okaya City, Nagano Prefecture: Relationship between Maternal and Child Health Information and Mental Health Status in the Sixth and Ninth Grades
Scientific Title:Acronym
Okaya Cohort Study: Relationship between Maternal and Child Health Information and Children's Mental Health Status
Region
| Japan |
Condition
Condition
Nonclinical population
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the association between children's perinatal risk, maternal postpartum depression, child characteristics at the infant health examination, indicators of maternal parenting stress, and preschool diagnostic information and mental health problems identified at sixth grade and ninth grade.
Basic objectives2
Others
Basic objectives -Others
Search for information that contributes to the early detection of mental health problems
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Children's Strengths and Difficulties Questionnaire, Ten-item Internet Gaming Disorder Test (IGDT-10) Japanese version, Screen Time Survey
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
| 11 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals born between April 2, 2010, and April 1, 2017, and their guardians.
2. Individuals enrolled in the sixth grade of elementary school or the sixth grade of junior high school within Okaya City at the time of the survey, and their guardians.
3. Participants who responded to the questionnaire and those included in the studies "Early Detection and Support for Children's Mental Health Issues Using Maternal and Child Health Information: A Comprehensive Cohort Study in Okaya City, Nagano Prefecture" (Approval Numbers 3297, 3614, 3905, 4324, 5603) and "A Comprehensive Cohort Study in Okaya City, Nagano Prefecture: Relationship between Maternal and Child Health Information and Mental Health Status in Sixth Grade" (Approval Numbers 5129).
Key exclusion criteria
Individuals deemed unsuitable as subjects by the principal investigator
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Daimei |
| Middle name | |
| Last name | Sasayama |
Organization
Shinshu University
Division name
Department of Psychiatry, School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263372638
sasayama@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Daimei |
| Middle name | |
| Last name | Sasayama |
Organization
Shinshu University
Division name
Department of Psychiatry, School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263372638
Homepage URL
sasayama@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Daimei Sasayama
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine Biological and Medical Research Ethics Committee
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263-37-3099
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
| 2025 | Year | 10 | Month | 05 | 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
| 2025 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2025 | Year | 10 | Month | 02 | Day |
Last modified on
| 2025 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066919
