UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059161 |
|---|---|
| Receipt number | R000067671 |
| Scientific Title | Examining the Usefulness of a Readiness Evaluation Checklist for Children with Severe Motor and Intellectual Disabilities and Their Parents in Transitioning to Post-Graduation Life from Special Support Schools |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/22 19:52:48 |
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Basic information
Public title
Examining the Usefulness of a Readiness Evaluation Checklist for Children with Severe Motor and Intellectual Disabilities and Their Parents in Transitioning to Post-Graduation Life from Special Support Schools
Acronym
Examining the Usefulness of a Readiness Evaluation Checklist for Children with Severe Motor and Intellectual Disabilities
Scientific Title
Examining the Usefulness of a Readiness Evaluation Checklist for Children with Severe Motor and Intellectual Disabilities and Their Parents in Transitioning to Post-Graduation Life from Special Support Schools
Scientific Title:Acronym
Examining the Usefulness of a Readiness Evaluation Checklist for Children with Severe Motor and Intellectual Disabilities
Region
| Japan |
Condition
Condition
severe motor and intellectual disabilities
Classification by specialty
| Neurology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to apply the Readiness Evaluation Checklist, which assesses the readiness of students with severe motor and intellectual disabilities and their parents for graduation, within career guidance, and to examine whether it leads to changes in the behaviors of teachers engaged in career guidance and parents of these students concerning preparation for life after graduation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Three career guidance sessions will be conducted. After each session, interviews will be held to evaluate the usefulness of the intervention, focusing on the following aspects:
Interview items for teachers
Points for improvement in the operation of career guidance with the introduction of the checklist
Usefulness of career guidance with the checklist (impact on teachers, impact on parents)
Presence and nature of changes in teachers' awareness regarding career guidance
Presence and nature of changes in teachers' behaviors regarding career guidance
Interview items for parents
Presence and nature of changes in parents' awareness regarding life after graduation
Presence and nature of preparatory actions taken toward graduation
Feelings experienced when receiving career guidance
Requests or suggestions for improvement regarding career guidance
Key secondary outcomes
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
After providing an explanation of this study to the participants and obtaining their informed consent, the action research will be initiated. The study will proceed as follows, and data will be collected accordingly.
Together with teachers in the career guidance department of the special support school that agreed to participate, a career guidance method incorporating the checklist will be developed. During this development process, approximately 30-minute interviews will be conducted to explore whether teachers experience changes in their awareness toward career guidance and whether there are changes in their behaviors related to career guidance. In addition, after each career guidance session is implemented, further 30-minute interviews will be conducted to obtain qualitative data on points for improvement in the operation of career guidance and on the usefulness of career guidance with the checklist. These interviews will be repeated after each implementation of career guidance with the checklist.
Similarly, after receiving career guidance, parents of children with severe motor and intellectual disabilities will be interviewed for about 30 minutes to collect qualitative data related to the study items. These interviews will also be conducted after each implementation of career guidance with the checklist.
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
| 25 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible participants will be (a) parents of students with severe motor and intellectual disabilities who are receiving career guidance, (b) the homeroom teachers of these students, and (c) teachers in the career guidance department. Inclusion requires that the students' health is stable, the participants express willingness to participate, and written informed consent is obtained after explanation of the study.
Key exclusion criteria
Exclusion criteria include (a) students with severe motor and intellectual disabilities whose health condition is unstable (e.g., frequent hospitalizations), as participation may pose physical or psychological burdens on the students and their parents, and (b) individuals who do not provide informed consent after explanation of the study.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Akemi |
| Middle name | |
| Last name | Yamazaki |
Organization
Osaka University
Division name
School of Medicine, Devision of Health Sciences
Zip code
565-0871
Address
1-7 Yamadaoka, Suita, Osaka
TEL
06-6879-5111
akemiyamazaki@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Nakayama |
Organization
Osaka University
Division name
School of Medicine, Devision of Health Sciences
Zip code
565-0871
Address
1-7 Yamadaoka, Suita, Osaka
TEL
06-6879-5111
Homepage URL
agogogogo321@gmail.com
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Osaka University
Address
2-2 Yamadaoka, Suita City, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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 | 10 | Month | 01 | 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 | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | 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
| 2025 | Year | 09 | Month | 22 | Day |
Last modified on
| 2025 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067671
