UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036857 |
|---|---|
| Receipt number | R000041991 |
| Scientific Title | Verification of the effectiveness of the work preparation program for adults with developmental disabilities |
| Date of disclosure of the study information | 2019/05/27 |
| Last modified on | 2019/05/27 00:28:13 |
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Basic information
Public title
Verification of the effectiveness of the work preparation program for adults with developmental disabilities
Acronym
Verification of the effectiveness of the work preparation program for adults with developmental disabilities
Scientific Title
Verification of the effectiveness of the work preparation program for adults with developmental disabilities
Scientific Title:Acronym
Verification of the effectiveness of the work preparation program for adults with developmental disabilities
Region
| Japan |
Condition
Condition
ASD,ADHD
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The Karasuyama Hospital Rehabilitation Center was developed at the Okayama Psychiatric Medical Center to conduct a work preparation program for adults with developmental disabilities. The purpose of this study is to consider the state of employment support for persons with developmental disabilities in adulthood.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post-Program outcome survey (working conditions, attributes of affiliated organizations)
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
A work preparation program for adult developmental Disorders developed at the Okayama Psychiatric Medical Center was conducted at the Karasuyama Hospital Rehabilitation Center.
Interventions/Control_2
control
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
1) A patient who is undergoing a visit to the Showa University Karasuyama Hospital and who is using the rehabilitation center, has been diagnosed with Autistic Spectrum syndrome or attention deficit hyperactivity disorder.
2) Patients who are at least 18 years of age when obtaining consent. 3) Patients who have received consent from the person in question about their participation in this study.
In addition, if the age is under 20 years old, the document consent from the person in charge is always obtained.
Key exclusion criteria
A person who is judged ineligible by the judgment of a physician in charge of research.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | MIKI |
| Middle name | |
| Last name | IGARASHI |
Organization
Institute of Developmental Disorders, Showa University
Division name
Institute of Developmental Disorders, Showa University
Zip code
1578577
Address
61111KITAKARASUYAMASETAGAYA
TEL
0333005231
m-igarashi@cmed.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | MIKI |
| Middle name | |
| Last name | IGARASHI |
Organization
Institute of Developmental Disorders, Showa University
Division name
Institute of Developmental Disorders, Showa University
Zip code
1578577
Address
61111KITAKARASUYAMASETAGAYA
TEL
0333005231
Homepage URL
m-igarashi@cmed.showa-u.ac.jp
Sponsor or person
Institute
Institute of Developmental Disorders, Showa University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health
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
Institute of Developmental Disorders, Showa University
Address
61111KITAKARASUYAMASETAGAYA
Tel
0333005231
m-igarashi@cmed.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
| 2019 | Year | 05 | Month | 27 | 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
| 2019 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 27 | 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 | 05 | Month | 27 | Day |
Last modified on
| 2019 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041991
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
