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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006237
Receipt No. R000007379
Scientific Title Verification of the effect of cognitive rehabilitation program for adults with autism spectrum disorders
Date of disclosure of the study information 2011/08/26
Last modified on 2015/09/26

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Basic information
Public title Verification of the effect of cognitive rehabilitation program for adults with autism spectrum disorders
Acronym Verification of the effect of cognitive rehabilitation program for adults with autism spectrum disorders
Scientific Title Verification of the effect of cognitive rehabilitation program for adults with autism spectrum disorders
Scientific Title:Acronym Verification of the effect of cognitive rehabilitation program for adults with autism spectrum disorders
Region
Japan

Condition
Condition Autism spectrum disorders (ASD)
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the small group with CBT intervention for adults with ASD by structured interview, questionnaire and cognitive function test
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Capacity of emotion understanding and regulation skills immediately and three months, 1year,1 and half year and 2years after intervention
Key secondary outcomes Psychiatric symptom and adaptive behavior immediately and three months, 1year,1 and half year and 2years after intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
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 Behavior Therapy
Interventions/Control_2 Psychotherapy
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
50 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients diagnosed with autistic disorder, Asperger's disorder, or PDD-NOS, based on DSM-IV-TR using Autism Diagnostic Observation Schedule or Autism Diagnostic Interview-Revised
2) Patients with normal intelligence (Verbal IQ is over almost100 and Full IQ is 0ver85 measured with Wechsler Adult Intelligent Scale Third Edition)

3)Schooling History: High school graduate or university degree

Key exclusion criteria Sever psychiatric comorbidity
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miho Kuroda
Organization Syukutoku University
Division name Department of Psychology
Zip code
Address 200 Daigenjicyo, Cyuoku, Chibashi, 260-871Japan
TEL 043-265-9878
Email pr6m-krd@asahi-net.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miho Kuroda
Organization National Center of Neurology and Psychiatry
Division name Department of Children and Adolescence mental Health, NIMH
Zip code
Address 4-1-1 Ogawahigashi, Kodairashi, Tokyo
TEL 042-341-2711
Homepage URL
Email pr6m-krd@asahi-net.or.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization National Center of Neurology and Psychiatry
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
Address
Tel
Email

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
2011 Year 08 Month 26 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 Completed
Date of protocol fixation
2011 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 30 Day
Date trial data considered complete
2015 Year 12 Month 30 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 08 Month 26 Day
Last modified on
2015 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007379

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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