UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050869 |
|---|---|
| Receipt number | R000057970 |
| Scientific Title | Creating and testing the effectiveness of a parent readiness model for high school students: a health class to enhance empathy. |
| Date of disclosure of the study information | 2023/04/17 |
| Last modified on | 2023/04/17 15:03:42 |
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Basic information
Public title
Creating and testing the effectiveness of a parent readiness model for high school students: a health class to enhance empathy.
Acronym
Creating and testing the effectiveness of a parent readiness model for high school students: a health class to enhance empathy.
Scientific Title
Creating and testing the effectiveness of a parent readiness model for high school students: a health class to enhance empathy.
Scientific Title:Acronym
Creating and testing the effectiveness of a parent readiness model for high school students: a health class to enhance empathy.
Region
| Japan |
Condition
Condition
Healthy people (high school students)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study was to evaluate the implementation of health education incorporating "empathy sessions" and its effectiveness in improving empathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The main outcome indicator was the Perspective-Taking subscale of an empathy index.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Groups attending health education incorporating empathy session programs.
Interventions/Control_2
Groups that do not attend health education.
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
| 15 | years-old | <= |
Age-upper limit
| 17 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
First-year high school students who participated in the study.
Key exclusion criteria
Exclusion criteria were data with missing values for Perspective-Taking, the main indicator of this study.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Goto |
Organization
Fukushima Medical University
Division name
Center for Integrated Science and Humanities
Zip code
960-1295
Address
1 Hikariga-oka Fukushima City
TEL
024-547-1111
agoto@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyo |
| Middle name | |
| Last name | Watanabe |
Organization
Fukushima Medical University
Division name
Center for Integrated Science and Humanities
Zip code
960-1295
Address
1 Hikariga-oka Fukushima City
TEL
09029840588
Homepage URL
d-kazuyo@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University Ethics Review Committee
Address
1 Hikariga-oka Fukushima City
Tel
024-547-1111
fmurec@fmu.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
| 2023 | Year | 04 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.jmaj.jp/detail.php?id=10.31662%2Fjmaj.2021-0033
Number of participants that the trial has enrolled
210
Results
Confounding factors, sex and mental health, were force entered in a binomial logistic regression analysis, and the probability of an increased Perspective-Taking scale score increased significantly for the intervention group, with an odds ratio of 2.29 (95 % confidence interval = 1.23-4.26). Cohen's r for each categorical item was 0.18 for the intervention condition (0.02 for sex and 0.06 for mental health), indicating a small effect size.
Results date posted
| 2023 | Year | 04 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 10 | Month | 15 | Day |
Baseline Characteristics
Japan, first-year student at a high school in the Tohoku region
Participant flow
Adverse events
nothing
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 17 | Day |
Last modified on
| 2023 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057970
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
