UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056940 |
|---|---|
| Receipt number | R000064626 |
| Scientific Title | The International Collaborative Research for Ijime (Bullying) Prevention and Intervention (ICoRIPI) to Address School Bullying and its Mental Health Determinants across Six Countries: Japan, Indonesia, Libya, Nigeria, Poland, and Taiwan |
| Date of disclosure of the study information | 2025/02/05 |
| Last modified on | 2025/02/05 10:58:46 |
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Basic information
Public title
The International Collaborative Research for Ijime (Bullying) Prevention and Intervention (ICoRIPI) to Address School Bullying and its Mental Health Determinants across Six Countries: Japan, Indonesia, Libya, Nigeria, Poland, and Taiwan
Acronym
ICoRIPI
Scientific Title
The International Collaborative Research for Ijime (Bullying) Prevention and Intervention (ICoRIPI) to Address School Bullying and its Mental Health Determinants across Six Countries: Japan, Indonesia, Libya, Nigeria, Poland, and Taiwan
Scientific Title:Acronym
ICoRIPI
Region
| Japan | Asia(except Japan) | Europe |
| Africa |
Condition
Condition
Bullying at school and its mental health determinants
Classification by specialty
| Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence, characteristics, and mental health determinants of school bullying across six culturally diverse countries, including Japan, Indonesia, Libya, Nigeria, Poland, and Taiwan, and to evaluate the effectiveness of a tailored anti-bullying program, the Niigata Ijime Prevention and Intervention Program (NIPIP).
Basic objectives2
Others
Basic objectives -Others
The 1st phase is the translation and cultural adaptation of instruments into each country's national language and a survey research design to standardize by investigating the validity and reliability of these instruments across diverse cultural contexts.
The 2nd phase is a cross-sectional multinational large-scale survey on school bullying and its mental health determinants.
The 3rd phase is a multicenter and prospective randomized controlled trial (RCT) on the effectiveness of the newly developed Niigata Ijime Prevention and Intervention Program (NIPIP).
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bullying Rates: A reduction in the number of reported bullying incidents, as measured by the OBVQ (Olweus Bully/Victim Questionnaire) and JaIS (Japan Ijime Scale) instruments.
Key secondary outcomes
a. Mental Health Indicators: Improvements in mental health determinants will be assessed using SDQ (Strengths and Difficulties Questionnaire), ASQ (Ask Suicide-Screening Questions), GAD-7 (Generalized Anxiety Disorder-7), and AQ (Autism-Spectrum Quotient) children/adolescents instruments.
b. Safe School Culture: Enhanced school climate will be evaluated through the PSSM instrument.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are 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
| Behavior,custom |
Interventions/Control_1
Intervention group: The intervention will be given to the intervention group in a one-year academic period, where the academic year starts and ends. The program, which is the Niigata Ijime Prevention and Intervention Program (NIPIP), is a team-based framework developed to systematically address bullying within schools.
Interventions/Control_2
Control group: The same intervention will also be given to the control group after the completion of the trial.
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
| 9 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Schools will be eligible to participate in the study if they meet the following inclusion criteria:
1. Obtain consent from the educational board and/or headteacher to participate,
2. No prior implementation of widely recognized evidence-based anti-bullying programs in school, and
3. Agree with a commitment to one year of data collection and program implementation for intervention schools and to be on the waiting list for intervention after the trial completion for the control schools.
All students enrolled in the consenting schools will be eligible to participate in self-reported and parent-report assessments.
Key exclusion criteria
Schools that intend exclusively for children with special needs or disabilities will not be invited to participate. In exceptional cases, schools face no negative consequences if they decide to stop participating in the middle of the study being conducted.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Ekachaeryanti |
| Middle name | |
| Last name | Zain |
Organization
Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
Division name
Department of Psychiatry
Zip code
951-8510
Address
757, Asahimachi-dori-ichibancho, Chuo-ku, Niigata City, Niigata Prefecture
TEL
025-227-2213
ekazain@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Ekachaeryanti |
| Middle name | |
| Last name | Zain |
Organization
Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
Division name
Department of Psychiatry
Zip code
951-8510
Address
757, Asahimachi-dori-ichibancho, Chuo-ku, Niigata City, Niigata Prefecture
TEL
025-227-2213
Homepage URL
http://www.niigata-dp.org/index.html
ekazain@med.niigata-u.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI for the International Joint Research Acceleration Fund (Overseas Collaborative Research)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Review Committee of Niigata University (Phase 1 is approved, Phase 2 and Phase 3 is on progress)
Address
757, Asahimachi-dori-ichibancho, Chuo-ku, Niigata City, Niigata Prefecture
Tel
+81-25-227-2625
ethics@adm.niigata-u.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
| 2025 | Year | 02 | Month | 05 | 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
| 2025 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2029 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Ethical approval for Phase 1 (translation and standardization) was obtained from the ethics committee of Niigata University (approval number 2023-0320) on April 2023, 2024. Subsequently, ethical approval documents for Phase 2 (multi-nation survey) and Phase 3 (RCT) studies will be submitted and processed consecutively.
Management information
Registered date
| 2025 | Year | 02 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064626
