UMIN-CTR Clinical Trial

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
Last 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
Email	haruhisap@med.showa-u.ac.jp

Public contact
1st 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
Email	haruhisap@med.showa-u.ac.jp

Sponsor
Institute	Showa University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041454