臨床研究等提出・公開システム

Date of registration	June. 16, 2026
Last modified on	June. 16, 2026
Trial ID	jRCT1030260230

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 Grade Children
Public Title	Cohort Study in Okaya City

Contact for Scientific Queries	Name	Sasayama Daimei
	Affiliation	Shinshu University
	Address	3-1-1 Asahi, Matsumoto
	Telephone	+81-263372638
	E-mail	sasayama@shinshu-u.ac.jp
Contact for Public Queries	Name	Sasayama Daimei
	Affiliation	Shinshu University
	Address	3-1-1 Asahi, Matsumoto
	Telephone	+81-263372638
	E-mail	sasayama@shinshu-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 01, 2025
Actual date of first enrollment		Nov. 01, 2025
Target sample size		2500
Study Type		Other
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1. Persons born between April 2, 2010 and April 1, 2017, and their caregivers. 2. Persons who, at the time of the survey, were enrolled as 6th-grade elementary school students or 3rd-grade junior high school students in Okaya City, and their caregivers. 3. Persons who agree (6th-grade students) and whose caregivers consent to responding to the questionnaire and to the use of data obtained from "Early Detection and Early Support for Children's Mental Health Problems Using Maternal and Child Health Information: A Complete Cohort Study in Okaya City, Nagano Prefecture" (Approval Nos. 3297, 3614, 3905, 4324, 5603) and "A Complete Cohort Study in Okaya City, Nagano Prefecture: The Relationship Between Maternal and Child Health Information and Mental Health Status in 6th-Grade Children" (Approval No. 5129).
	Exclusion Criteria	Persons whom the principal investigator determines to be unsuitable as research participants.
	Age Minimum	11age old over
	Age Maximum	15age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		N/A
Health Condition(s) Keyword		mental health
Health Condition(s) Code		N/A
Primary Outcome(s)		Strength and Difficulties Questionnaire

Primary Sponsor	None

Secondary Sponsor

Source of Monetary Support	Ministry of Education, Culture, Sports, Science and Technology
Secondary Sponsor	Not applicable

Name of Certified Review Board	Shinshu University School of Medicine Biological and Medical Research Ethics Committee
Address	3-1-1 Asahi, Matsumoto, Nagano
Telephone	+81-263-37-2572
E-Mail	md_rinri@shinshu-u.ac.jp
Approval Status	Approval
Date of approval	Sept. 24, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none