UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060784 |
|---|---|
| Receipt number | R000069543 |
| Scientific Title | Development and Effectiveness Evaluation of a Group-Based Education Programme Incorporating Active Learning |
| Date of disclosure of the study information | 2026/02/28 |
| Last modified on | 2026/02/28 05:18:16 |
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Basic information
Public title
Development and Effectiveness Evaluation of a Group-Based Education Programme Incorporating Active Learning
Acronym
Development and Effectiveness Evaluation of a Group-Based Education Programme Incorporating Active Learning
Scientific Title
Development and Effectiveness Evaluation of a Group-Based Education Programme Incorporating Active Learning
Scientific Title:Acronym
Development and Effectiveness Evaluation of a Group-Based Education Programme Incorporating Active Learning
Region
| Japan |
Condition
Condition
adolescence
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop and implement a group-based sex education programme for adolescents, incorporating active learning approaches based on comprehensive sexuality education principles, and to examine changes in short-term outcomes through a pre-post comparative trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sexual Risk Coping Awareness Scale (Immediately after programme implementation, one month later)
Key secondary outcomes
Sexual Self-Awareness Scale (Immediately after programme implementation, one month later)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
sex education
Interventions/Control_2
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
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those enrolled in high school
Key exclusion criteria
Those enrolled in special needs schools
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Yuto |
| Middle name | |
| Last name | Ichinohe |
Organization
Sapporo city university
Division name
Nursing
Zip code
0600011
Address
13-chome, Kita-juichijo, Sapporo, Hokkaido
TEL
011-726-2500
y.ichinohe@scu.ac.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Ichinohe |
Organization
Sapporo city university
Division name
Nursing
Zip code
0600011
Address
Kita 11 Nsihi 13, Chuo-ku, Sapporo, Hokkaido
TEL
011-726-2500
Homepage URL
y.ichinohe@scu.ac.jp
Sponsor or person
Institute
Sapporo city university
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo City University Ethics Committee
Address
1-chome, Geijutsu no Mori, Minami Ward, Sapporo City, Hokkaido
Tel
011-592-2346
rinri-sinsei@scu.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
| 2026 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2026 | Year | 02 | Month | 28 | Day |
Last modified on
| 2026 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069543
