UMIN-CTR Clinical Trial

Public title

Project to evaluate the effect of school climate intervention

Acronym

Project to evaluate the effect of school climate intervention

Scientific Title

Evaluation of the effectiveness of school climate intervention

Scientific Title:Acronym

Evaluation of the effectiveness of school climate intervention

Region

Japan

Condition

School climate

Classification by specialty

Child

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effectiveness of school climate intervention.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Adolescents' perceived school climate will be assessed using the Japanese version of the Beyond Blue School Climate Questionnaire (BBSCQ) (Shinde et al., 2019; Sasaki et al., in preparation). The response scale of the BBSCQ will be modified from a two-point to a six-point scale. The primary outcomes will be the BBSCQ total score and its subscale scores at the end of the eight-month intervention. Follow-up assessments at 12 and 20 months after the intervention will also be conducted and used as follow-up outcomes.

Shinde et al., Lancet, 2019;392(10163):2465-77

Key secondary outcomes

We will assess well-being, depressive symptoms, loneliness, problematic internet use, bullying victimisation, interpersonal trust, anger management, and the number of trusted adults at school using a self-report questionnaire. Data on school absenteeism (number of days absent) will be obtained from participating schools. For school absenteeism, the outcome will be the total number of days absent during the intervention period, while all other outcomes will be assessed using scores at the end of the eight-month intervention. The same assessments will also be conducted at 12 and 20 months after the intervention, and scores at each time point will be treated as secondary outcomes.

Well-being and depressive symptoms will be assessed using the WHO-5 (Awata et al., 2007) and the Short Mood and Feelings Questionnaire (SMFQ) (Angold et al., 1995). Loneliness will be assessed using a single SMFQ item ("I felt lonely"). Problematic internet use will be assessed using the CIUS (Meerkerk et al., 2009). Bullying victimisation will be assessed using an adapted version of the OBVQ-R (Gaete et al., 2021). Interpersonal trust will be assessed using a single item ("Most people can be trusted") (Tsomokos et al., 2024). Anger management will be assessed using a single SDQ item ("I get very angry and often lose my temper.") (Goodman, 1997). The number of trusted adults at school will be assessed using a single item ("There are adults at school I can talk to easily"). School absenteeism will be treated as an exploratory outcome. In addition, fidelity assessments will be conducted to evaluate the extent to which interventions are implemented according to the current protocol.

Awata et al., Int Psychogeriatr, 2007;19:77-88
Angold et al., Int J Methods Psychiatr Res, 1995;5:237-49
Meerkerk et al., Cyberpsychol Behav, 2009;12(1):1-6
Gaete et al., Front Psychol 2021;12:578661
Tsomokos et al., Nat Ment Health, 2024;2:328-36
Goodman R., J Child Psychol Psychiatry, 1997;38:581-86

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

1. The intervention is a multicomponent whole-school programme aimed at improving school climate and adolescent mental health. It is implemented collaboratively with students and school staff under the support of an external coordinator.

2. The intervention comprises three components: a whole-school approach, a peer-group approach, and an individual approach.
The whole-school approach aims to strengthen opportunities for student voice, enhance communication within the school community, and promote awareness of school climate and mental health through school-wide activities.
The peer-group approach aims to promote students' active involvement in improving the school environment through participatory activities.
The individual approach aims to facilitate appropriate support for students experiencing difficulties by linking them to existing school-based support resources where necessary.

3. To disseminate activities across the whole school, capture students' views, and share information, the following activities may be implemented under the support of the coordinator as needed:
- Establishment of mechanisms to collect students' opinions and suggestions
- School-wide surveys to gather students' views
- Communication of activities and progress
- Dissemination of information through posters and other materials
- Presentations at school assemblies and other events

Interventions/Control_2

(Continued)
4. Opportunities will be provided for students and school staff to engage in discussions on topics related to school climate, including mental health, interpersonal relationships, bullying, digital device use, and diversity, equity, and inclusion.

5. Students' participation will be encouraged as needed to support the implementation of activities described in sections 3 and 4.

6. Coordinators will receive training prior to the start of the intervention and ongoing supervision during the intervention period. Fidelity assessments will be conducted to evaluate the extent to which the intervention is implemented as intended.

7. Opportunities will be provided for school staff to enhance their understanding of the purpose and content of the intervention to facilitate its smooth implementation.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

12

years-old

<=

Age-upper limit

16

years-old

>=

Gender

Male and Female

Key inclusion criteria

Participants will be first-year students in Japanese public junior high schools and senior high schools.
As this study implements the intervention at the school level, participating schools will first be recruited. Eligibility criteria for schools are public junior high schools or public senior high schools.

Randomisation
Once candidate schools are identified, allocation to intervention or control groups will be conducted using a computer-generated random sequence. Stratified randomisation will be applied to balance school characteristics (e.g., school type and region). The allocation ratio will be 1:1. Randomisation will be conducted by a researcher who is not involved in the implementation of the intervention or outcome assessment, and the allocation will be communicated to the participating schools.

Allocation concealment is not applicable in this study, as it is a whole-school intervention implemented at the school level. Schools and teaching staff need to be aware of the allocation in order to implement the intervention.

However, after allocation at the school level, an approximately one-year embedding phase will be conducted to allow schools to understand and fully implement the intervention. Outcome evaluation will be conducted using data from all first-year students newly enrolled in the following academic year who were not exposed to the intervention during the embedding phase.

This design ensures that participants included in the evaluation are not exposed to the intervention at the time of allocation and are assessed without being influenced by allocation status. This type of embedding phase is essential for implementing complex whole-school interventions (Shinde et al., 2018).

Shinde et al., Lancet, 2019;392(10163):2465-77

Key exclusion criteria

None.

Target sample size

1400

Name of lead principal investigator

1st name	Atsushi
Middle name
Last name	Nishida

Organization

Tokyo Metropolitan Institute of Medical Science

Division name

Research Center for Social Science & Medicine

Zip code

156-8506

Address

2-1-6 Kamikitazawa, Setagaya-ku, Tokyo

TEL

+81-3-5316-3100

Email

nishida-at@igakuken.or.jp

Name of contact person

1st name	Satoshi
Middle name
Last name	Yamaguchi

Organization

Tokyo Metropolitan Institute of Medical Science

Division name

Research Center for Social Science & Medicine

Zip code

156-8506

Address

2-1-6 Kamikitazawa, Setagaya-ku, Tokyo

TEL

+81-3-5316-3100

Homepage URL

Email

yamaguchi-st@igakuken.or.jp

Institute

Tokyo Metropolitan Institute of Medical Science

Institute

Department

Personal name

Organization

Tokyo Metropolitan Government

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Human Subjects Ethics Committee, Tokyo Metropolitan Institute of Medical Science

Address

2-1-6 Kamikitazawa, Setagaya-ku, Tokyo

Tel

+81-3-6834-2391

Email

renkei@igakuken.or.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

03

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2025

Year

03

Month

31

Day

Date of IRB

2025

Year

03

Month

27

Day

Anticipated trial start date

2026

Year

04

Month

01

Day

Last follow-up date

2028

Year

01

Month

31

Day

Date of closure to data entry

2028

Year

03

Month

31

Day

Date trial data considered complete

2028

Year

04

Month

30

Day

Date analysis concluded

2028

Year

06

Month

30

Day

Other related information

Power analysis
Power analysis was conducted regarding the change in BBSCQ scores from baseline to the eight-month intervention (primary outcome) between the intervention and control groups, to assess the effectiveness of the intervention, using PowerUpR (Dong & Maynard, 2013). The intervention and control groups were set at a 1:1 ratio. Based on a prior school climate intervention (Shinde et al., 2019), the effect size of the intervention was set at d = 0.6, with an intra-class correlation of schools at 0.10. The standard number of students per grade in schools was assumed to be 100, with a dropout rate of 10%, considering the high participation and retention rates in school-based studies. The correlation between baseline BBSCQ scores and scores at the eight-month intervention was assumed to be r = 0.5. A two-tailed test was utilized, with a significance level of a = 0.05. Under these conditions, sufficient statistical power (0.88) was achieved with a total of 14 schools (7 intervention schools and 7 control schools) (n = 1400), using the statistical model shown in the "Other" section.

Dong & Maynard, J Res Educ Eff, 2013;6(1):24-67
Shinde et al., Lancet, 2019;392(10163):2465-77

Statistical analysis
All analyses will be conducted on an intention-to-treat basis. Intervention effects will be evaluated by comparing outcome scores between groups at 8, 12, and 20 months after the intervention. The same analyses will also be conducted for secondary outcomes. Prespecified subgroup analyses will be conducted according to gender, school type, and baseline depressive symptom severity. These analyses will be exploratory and aim to assess potential heterogeneity of intervention effects.

Registered date

2025

Year

03

Month

31

Day

Last modified on

2026

Year

04

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065628