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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036857
Receipt No. 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

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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
Email 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
Email m-igarashi@cmed.showa-u.ac.jp

Sponsor
Institute Institute of Developmental Disorders, Showa University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041991

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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