臨床研究等提出・公開システム

Date of registration	Aug. 19, 2022
Last modified on	Aug. 19, 2022
Trial ID	jRCT1030220279

Scientific Title	Early detection and intervention for mental health problems in children using maternal and child health database: a cohort study in Okaya City
Public Title	Okaya cohort study

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

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 19, 2022
Target sample size		1500
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Children who attended the health checkups for infants and children in Okaya and were born between April 2, 2017 and April 1, 2022 and
	Exclusion Criteria	Those who opted out.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Early detection and intervention of mental health problems
Primary Outcome(s)		Psychiatric diagnosis

Primary Sponsor	Daimei Sasayama

Secondary Sponsor

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

Name of Certified Review Board	Ethics committee, Shinshu University School of Medicine
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	Aug. 08, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none