UMIN-CTR Clinical Trial

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
Last 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
1st 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