UMIN-CTR Clinical Trial

Basic information
Public title	Research on mental health of children and adults
Acronym	Research on mental health of children and adults
Scientific Title	Research on mental health of children and adults
Scientific Title:Acronym	Research on mental health of children and adults
Region	Japan

Condition
Condition	Healthy adults and children
Classification by specialty	Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We measure the influence of the treasure file program on the self esteem of children and adults, and evaluate the effectiveness of the program by converting changes to children's and adult self-esteem as data.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	physical well-being, emotional well-being, self-esteem, family, friends and everyday functioning (school or nursery school/kindergarten) on Kid-KINDL Questionnaire
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Overview of TFP Session 1:Write a purpose, put a photo, and write a dream or a wish Session 2:Write their own strengths Session 3:Name the file and make a cover page Session 4:Write strengths of friends in each other Session 5:Write the strengths of their family members Session 6:Write their own strengths once again Session 7:Write their improving points while looking at the file At the same time as Session 4 and Session 5, homeroom teacher and families write their own strength and give it to them. A questionnaire survey was done before and after that session. Each session was conducted by the homeroom teachers. A handbook with detailed contents of the program was handed to each homeroom teacher in the intervention group, and about 2 hours of training were conducted before and during the program. To assess self-esteem, Kindl-R questionnaire was used.
Interventions/Control_2	Approximately half of the students are out of program implementation as control group. In the control group, we usually do lessons during the treasure file program. Before and after that, measure the effect of regular lessons in self-esteem area using KINDL-R elementary school version, junior high school version and mother version.
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	16 years-old >
Gender	Male and Female
Key inclusion criteria	Children enrolled in elementary and junior high school classes
Key exclusion criteria	Children who were absent from class during the research period
Target sample size	6000

Research contact person
Name of lead principal investigator	1st name Hideo Middle name Last name Matsuzaki
Organization	University of Fukui
Division name	Research Center for Child Mental Development
Zip code	9101193
Address	23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193
TEL	0776-61-8803
Email	matsuzah@u-fukui.ac.jp

Public contact
Name of contact person	1st name Miyuki Middle name Last name Iwahori
Organization	University of Fukui
Division name	Research Center for Child Mental Development
Zip code	9101193
Address	23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193
TEL	0776-61-8804
Homepage URL
Email	iwahorimiyuki@gmail.com

Sponsor
Institute	University of Fukui
Institute
Department

Funding Source
Organization	University of Fukui
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	MRSC, University of Fukui Hospital
Address	23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
Tel	0776-61-8205
Email	smsien-k@ad.u-fukui.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	福井大学

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	1386
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	The article was not accepted yet.
Date of the first journal publication of results
Baseline Characteristics	primary school children
Participant flow	primary school
Adverse events	None
Outcome measures	Physical well-being, Emotional well-being, Self-esteem, Family, Friends, and School were evaluated as subscale of health related quality of life measure for children by using KINDL-R.
Plan to share IPD	None
IPD sharing Plan description	None

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 21 Day
Date of IRB	2016 Year 03 Month 16 Day
Anticipated trial start date	2016 Year 03 Month 16 Day
Last follow-up date	2019 Year 03 Month 01 Day
Date of closure to data entry	2019 Year 03 Month 01 Day
Date trial data considered complete	2019 Year 03 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 10 Month 30 Day
Last modified on	2021 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033995