UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029757 |
|---|---|
| Receipt number | R000033995 |
| Scientific Title | Research on mental health of children and adults |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2021/11/02 10:04:19 |
* 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
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
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
iwahorimiyuki@gmail.com
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033995
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
