UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036389 |
|---|---|
| Receipt number | R000041454 |
| Scientific Title | Development of a rehabilitation program for collage students with neurodevelopmental disorders. |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2019/04/02 23:26:37 |
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Basic information
Public title
Development of a rehabilitation program for collage students with neurodevelopmental disorders.
Acronym
Development of a rehabilitation program for collage students with neurodevelopmental disorders.
Scientific Title
Development of a rehabilitation program for collage students with neurodevelopmental disorders.
Scientific Title:Acronym
Development of a rehabilitation program for collage students with neurodevelopmental disorders.
Region
| Japan | Asia(except Japan) |
Condition
Condition
Autism spectrum disorder
Attention deficit hyperactivity disorder
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verifying the effects of the rehabiltaiton program for college students with neurodevelopment 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 form school ,start working )
Key secondary outcomes
AQ(Autism Spectrum Quotient)
SRS-A
SCQ(Social Communication Questionnaire)
CAARS(Conners Adult ADHD Rating Scales)
STAI(State-Trait Anxiety Inventory)
GSES(General Self-Efficacy Scale)
WHOQOL26
CSQ(Communication Skills Questionnaire)
WFIRS-S(Weiss Functional Impairment Rating Scale)
Vineland-II
GAF(Global Assessment of Functioning)
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
Rehabilitation 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 students with neurodevelopmental disorders
Key exclusion criteria
Individuals who are jugged as unfit for the program by their doctors
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Haruhisa |
| Middle name | |
| Last name | Ohta |
Organization
Showa University
Division name
Medical Institute Neurodevelopmental Research
Zip code
157-8577
Address
6-11-11, Kitakarasuyama, Setagaya-ku, Tokyo, Japan
TEL
03-3300-5231
haruhisap@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruhisa |
| Middle name | |
| Last name | Ohta |
Organization
Showa University
Division name
Medical Institute Neurodevelopmental Research
Zip code
157-8577
Address
6-11-11, Kitakarasuyama, Setagaya-ku, Tokyo, Japan
TEL
03-3300-5231
Homepage URL
haruhisap@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
lnstitutional Review Board of ShowaUniversity Karasuyama Hospital
Address
6-11-11, Kitakarasuyama, Setagaya-ku, Tokyo, Japan
Tel
03-3300-5231
showa-crc@ofc.showa-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
| 2022 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2021 | 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 | 04 | Month | 02 | Day |
Last modified on
| 2019 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041454
