UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004560 |
|---|---|
| Receipt number | R000005449 |
| Scientific Title | A social skills intervention for children with High-Functioning Autism,Asperger syndrome:pilot randomized controlled treatment study suggesting effectiveness |
| Date of disclosure of the study information | 2011/01/17 |
| Last modified on | 2014/02/13 22:03:57 |
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Basic information
Public title
A social skills intervention for children with High-Functioning Autism,Asperger syndrome:pilot randomized controlled treatment study suggesting effectiveness
Acronym
A social skills intervention for children with High-Functioning Autism,Asperger syndrome:pilot randomized controlled treatment study suggesting effectiveness
Scientific Title
A social skills intervention for children with High-Functioning Autism,Asperger syndrome:pilot randomized controlled treatment study suggesting effectiveness
Scientific Title:Acronym
A social skills intervention for children with High-Functioning Autism,Asperger syndrome:pilot randomized controlled treatment study suggesting effectiveness
Region
| Japan |
Condition
Condition
developmental disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the psychosocial intervention for individuals with high functioning autism,asperger syndrome and their mothers by observation and questionnaire,and to verify the feasibilityof the program
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
psychiatric symptom of children after 6 months,12 months after intervention
Key secondary outcomes
psychiatric symptom of mother and social function of children after 6 months,12 months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
social skills training
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
| 5 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
DQ(developmental quantile)>75
children of 1 year before entering the elementary school
Key exclusion criteria
other psychiatric disorder (conduct disorder,Obsessive compulsive disorder)
Chromosomal abnormality
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kayoko Ichikawa |
Organization
University of Kyoto,School of Public Health
Division name
Department of Health Informatics
Zip code
Address
yoshida konoe-cho,sakyo-ku,kyoto,606-8501,JAPAN
TEL
075-753-9479
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichikawa Kayoko |
Organization
University of Kyoto,School of Public Health
Division name
Department of Health Informatics
Zip code
Address
yoshida konoe-cho,sakyo-ku,kyoto,606-8501,JAPAN
TEL
075-753-9479
Homepage URL
kayoko-ichikawa@umin.ac.jp
Sponsor or person
Institute
department Health Informatics,School of Public Health University of Kyoto
Institute
Department
Personal name
Funding Source
Organization
meiji-yasuda mental heallth foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
syousin-en Osaka Psychiatric Medical center
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
独立行政法人大阪府立精神医療センター 松心園
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.bpsmedicine.com/content/7/1/14
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
| 2010 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 15 | Day |
Last modified on
| 2014 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005449
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
