UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039002 |
|---|---|
| Receipt number | R000044477 |
| Scientific Title | Development of a rehabilitation program for collage and graduate students with neurodevelopmental disorders |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2026/01/30 11:11:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of a rehabilitation program for collage and graduate students with neurodevelopmental disorders
Acronym
Development of a rehabilitation program for collage and graduate students with neurodevelopmental disorders
Scientific Title
Development of a rehabilitation program for collage and graduate students with neurodevelopmental disorders
Scientific Title:Acronym
Development of a rehabilitation program for collage and graduate students with neurodevelopmental disorders
Region
| Japan |
Condition
Condition
Autism spectrum disorder
Attention deficit hyperactivity disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verifying the effects of the rehabiltaiton
program for college students with neuro
development disorders
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcome of university life (e.g. withdraw from school, start working )
Key secondary outcomes
AQ(Autism Spectrum Quotient)
GSES(General Self-Efficacy Scale)
WHOQOL26
SASS-J(Social Self-Adaptation Evaluation Scale Japanese version
GHQ12
Social Support Scales for Japanese College Students
CSQ-8(Communication Skills Questionnaire)
Face sheet
Vineland-II
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Rhabilitation program group
Interventions/Control_2
control group
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
College and graduate students with neurodevelopmental disorders
Key exclusion criteria
Individuals who are jugged as unfit for the program by their doctors
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Ide |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
3058575
Address
1-1-1Tennodai, Tsukuba, Ibaraki, Japan
TEL
0298533182
idem@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Ide |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
3058575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
0298533182
Homepage URL
idem@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical ethics committee of the University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel
029-853-3022
sien.ningenss@un.tsukuba.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
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://ahead-japan.org/journal/05-01/02.html
Publication of results
Published
Result
URL related to results and publications
https://ahead-japan.org/journal/05-01/02.html
Number of participants that the trial has enrolled
3
Results
GHQ-12 scores decreased for both A and B groups before and after the programme.
WHO QOL-26, GSES scores, Scores on the SASS-J and The University Student Social Support Scale showed increases for both A and B.
AQ scores remained largely unchanged for both A and B, indicating no change in autism spectrum disorder characteristics throughout the programme.
C showed opposite changes to A and B on the GHQ-12, WHO QOL-26, SASS-J, and University Student Social Support Scale.
Results date posted
| 2026 | Year | 01 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were recruited for the programme, with three individuals who expressed interest being selected.
Age: 22-23 (third-year university students to first-year postgraduate students)
Gender: All female
Diagnosis: Two with ASD, one with co-occurring ASD and ADHD
Participant flow
Utilising the university's extended holiday period, the programme was conducted weekly for two hours per session: the first seven sessions from February to March 2021, and the final five sessions from June to July 2021.
Two participants (A and B) attended all sessions, while one participant (C) was unable to attend due to scheduling conflicts and participated only in selected sessions (Sessions 10 and 11). Session 10 featured a lecture by an external instructor, while Session 11 covered key considerations for job hunting. Participant C did not attend the workshop-style programme sessions, which formed the core element of this initiative and involved sharing difficulties and considering solutions. Consequently, Participant C was used as a comparison group to evaluate the effectiveness of the workshop-style programme.
Adverse events
Nothing
Outcome measures
GHQ-12
WHO QOL-26
GSES
SASS-J
The University Student Social Support Scale
AQ
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2019 | Year | 12 | Month | 26 | Day |
Last modified on
| 2026 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044477
