UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060014 |
|---|---|
| Receipt number | R000068639 |
| Scientific Title | Examination of Occupational Therapy Implementation Tools Aimed at Promoting Collaboration with School Staff in Supporting School-Aged Children and Students with School Refusal |
| Date of disclosure of the study information | 2025/12/08 |
| Last modified on | 2025/12/08 14:46:18 |
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Basic information
Public title
Examination of Occupational Therapy Implementation Tools Aimed at Promoting Collaboration with School Staff in Supporting School-Aged Children and Students with School Refusal
Acronym
Development of Occupational Therapy Collaboration Tools for Educators Supporting Students with School Refusal
Scientific Title
Examination of Occupational Therapy Implementation Tools Aimed at Promoting Collaboration with School Staff in Supporting School-Aged Children and Students with School Refusal
Scientific Title:Acronym
Examination of Occupational Therapy Implementation Tools for Supporting Children and Students Who Refuse to Attend School
Region
| Japan |
Condition
Condition
School Refusing Children and Students
Classification by specialty
| Pediatrics | Psychiatry | Rehabilitation medicine |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarifying Current Challenges: Through interviews with school staff and occupational therapists, we will comprehensively identify current challenges in supporting school refusal within school settings, as well as the need for collaboration with medical institutions (occupational therapists).
Basic objectives2
Others
Basic objectives -Others
Development of Support Tools: Based on the above survey findings, derive the components of "Tools for Introducing Occupational Therapy" designed to enable faculty and staff to readily utilize occupational therapy perspectives and expertise while deepening collaboration with healthcare institutions (occupational therapists). Subsequently, evaluate and develop the validity of these tools.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.The current state and challenges in the field of school education for school-age children and students who refuse to attend school are clearly structured through qualitative analysis using SCAT and extracted as categories and storylines.
2.Opinions and values regarding the role of occupational therapy in supporting school-age children and students who refuse to attend school are extracted as distinct categories through inductive thematic analysis.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. School staff with experience supporting students who school refusal
2. Occupational therapists with over 10 years of clinical experience specializing in pediatrics or psychiatry, or with experience working in child welfare facilities.
Key exclusion criteria
Individuals who do not consent to participate in this study
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Motoki |
| Middle name | |
| Last name | Kurumai |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Neurodevelopmental Disorders
Zip code
467-8601
Address
1 Kawasumi Mizuho-cho Mizuho-ku Nagoya Aichi
TEL
052-853-8760
tambietvn2018@gmail.com
Public contact
Name of contact person
| 1st name | Motoki |
| Middle name | |
| Last name | Kurumai |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Neurodevelopmental Disorders
Zip code
467-8601
Address
1 Kawasumi Mizuho-cho Mizuho-ku Nagoya Aichi
TEL
052-853-8760
Homepage URL
tambietvn2018@gmail.com
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
International University of Health and Welfare
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Secretariat, IRB of Nagoya City University Graduate School of Medical Sciences
Address
1 Kawasumi Mizuho-cho Mizuho-ku Nagoya Aichi
Tel
052-853-8346
rinshou-kenkyuu@med.nagoya-cu.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 | 12 | Month | 08 | 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 | 11 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a qualitative observational study that does not involve any intervention or treatment. Data will be collected through semi-structured interviews and Focus Group Discussions (FGD) with teaching staff and occupational therapists to structurally clarify the challenges in truancy support and the potential for introducing occupational therapy.
Management information
Registered date
| 2025 | Year | 12 | Month | 08 | Day |
Last modified on
| 2025 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068639
