UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on patients with developmental disorder
Acronym	Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on patients with developmental disorder
Scientific Title	Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on patients with developmental disorder
Scientific Title:Acronym	Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on patients with developmental disorder
Region	Japan

Condition
Condition	patients with developmental disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Multi dimensional Scale for PDD and ADHD:MSPA, Achenbach System of Empirically Based Assessment Adult Self Report:ASR, Brief Assessment of Cognition in Schizophrenia: BACS, Self Efficacy for Community Life scale: SECL, Life Assessment Scale for Mental Ill: LASMI, and The Global Assessment of Functioning Scale: GAF after cognitive rehabilitation for 6 months
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Factorial
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	Behavior,custom
Interventions/Control_1	cognitive rehabilitation
Interventions/Control_2	twice a week, 6 months
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	it was judged a psychiatrist to patients with developmental disorder
Key exclusion criteria	intelligence quotient more than 70 by Wechsler Adult Intelligence Scale- Third Edition,exclude dementia
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Ohno
Organization	Kawasaki University of Medical Welfare
Division name	Department of Occupational Therapy
Zip code	701-0193
Address	288, Matsushima, Kurashiki-city, Okayama 701-0193, Japan
TEL	086-462-1111
Email	h-oono@mw.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Hiroaki Middle name Last name Ohno
Organization	Kawasaki University of Medical Welfare
Division name	Department of Occupational Therapy
Zip code	701-0193
Address	288, Matsushima, Kurashiki-city, Okayama 701-0193, Japan
TEL	086-462-1111
Homepage URL
Email	h-oono@mw.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki University of Medical Welfare Department of Occupational Therapy
Institute
Department

Funding Source
Organization	Kawasaki University of Medical Welfare
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kawasaki University of Medical Welfare
Address	288, Matsushima, Kurashiki-city, Okayama 701-0193, Japan
Tel	086-462-1111
Email	h-oono@mw.kawasaki-m.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	川崎医科大学付属病院（岡山県）

Other administrative information
Date of disclosure of the study information	2019 Year 08 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	Preinitiation
Date of protocol fixation	2019 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2024 Year 06 Month 30 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 23 Day
Last modified on	2019 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041958

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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