UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017860 |
|---|---|
| Receipt number | R000017366 |
| Scientific Title | Evaluation of a Cognitive Remediation Therapy in patients with Autism Spectrum Disorders. in adults : a pilot study |
| Date of disclosure of the study information | 2015/06/10 |
| Last modified on | 2016/12/21 14:07:48 |
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Basic information
Public title
Evaluation of a Cognitive Remediation Therapy in patients with Autism Spectrum Disorders. in adults : a pilot study
Acronym
Evaluation of a Cognitive Remediation Therapy in patients with Autism Spectrum Disorders. in adults : a pilot study
Scientific Title
Evaluation of a Cognitive Remediation Therapy in patients with Autism Spectrum Disorders. in adults : a pilot study
Scientific Title:Acronym
Evaluation of a Cognitive Remediation Therapy in patients with Autism Spectrum Disorders. in adults : a pilot study
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effectiveness and feasibility of cognitive behavioral therapy for Autism Spectrum Disorders. in Japanese clinical settings.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brixton Test
ROCF
Key secondary outcomes
TMT
Stroop Test
WCST
CFS
PHQ-9
GAD-7
RSES
HADS (A), (D)
EQ-5D
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
10 sessions of Cognitive Remediation Therapy
Interventions/Control_2
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
| 8 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with Autism Spectrum Disorders.
Key exclusion criteria
Individuals who have histories of substance abuse, active suicidality, severe mental and physical condition, global assesment of functioning < 50,intelligence quotient < 80, and psychiatric disorders associated with substance abuse
Target sample size
19
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiko Nakazato |
Organization
Graduate School of Medicine, Chiba University
Division name
Research Center for Child Mental Development
Zip code
Address
1-8-1, inohana, Chuo-ku, Chiba city
TEL
043-226-2975
nakazato@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Asano |
Organization
Graduate School of Medicine, Chiba University
Division name
Research Center for Child Mental Development
Zip code
Address
1-8-1, inohana, Chuo-ku, Chiba city
TEL
043-226-2975
Homepage URL
kenichi.asano1225@gmail.com
Sponsor or person
Institute
Research Center for Child Mental Development, Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports,Science and Technology
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
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
| 2015 | Year | 06 | Month | 10 | 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
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 10 | Day |
Last modified on
| 2016 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017366
