UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006324 |
|---|---|
| Receipt number | R000007498 |
| Scientific Title | A randomized controlled trial of a GO intervention program for elementary school children's cognitive functions and control abilities of emotion and behavior |
| Date of disclosure of the study information | 2011/09/11 |
| Last modified on | 2011/09/11 06:33:42 |
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Basic information
Public title
A randomized controlled trial of a GO intervention program for elementary school children's cognitive functions and control abilities of emotion and behavior
Acronym
A GO intervention study for elementary school children
Scientific Title
A randomized controlled trial of a GO intervention program for elementary school children's cognitive functions and control abilities of emotion and behavior
Scientific Title:Acronym
A GO intervention study for elementary school children
Region
| Japan |
Condition
Condition
Typically developed elementary school children
Classification by specialty
| Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to conduct the first randomized controlled trial of a GO intervention for elementary school children to assess the intervention effectiveness in enhancing child cognitive functions and control abilities of emotion and behavior.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the number of correct answer in the Stroop task
Key secondary outcomes
reverse Stroop interference rate and Stroop interference rate in the Stroop task
the scores of the forward and backward of the digit span test in the WISC3
the total score of the Raven's Colored Progressive Matrix
the scores of the forward and backward of the Span-board task of the WAIS RNI
BIS, BAS Reward Responsiveness, BAS Drive, BAS Fun Seeking of the Behavioral Inhibition and Behavioral Activation Scales
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
We will ask the participants of the intervention group to join the GO course which will be held once every week for five weeks, total six times. In the GO course, the children will be taught GO by the GO masters of the Nihon Kiin and enjoy playing it for an hour, using a 6 by 6 or a 9 by 9 board, both of which are suitable for GO beginners. In addition to this course, the participants will perform GO problems for approximately twenty minutes a day, three times a week during the intervention period. To make the problems suitable for the child beginner level, the GO problems will be chosen by the staff of the Nihon Kiin. The staff is well experienced at designing beginner GO courses for tutoring elementary school children.
Interventions/Control_2
The participants of the control group will spend usual daily life.
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
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)From age 8 to 10 years old (from the second to fourth grade of elementary school)
2)No experience playing GO
3)Interested in playing GO
4)Children able to attend all the classes of the GO courses (total of five times)
5)Children who have consent to do the GO tasks for twenty minutes a day three times a week for five weeks
Key exclusion criteria
A current clinically severe illness or disorder making it impossible to perform the intervention program
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuta |
Organization
IDAC, Tohoku University
Division name
Smart Aging International Research Center
Zip code
Address
Seiryou-machi 4-1, Aoba-ku, Sendai-shi, Miyagi-ken 980-8575, Japan
TEL
+81-22-717-7988
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Tachibgana |
Organization
IDAC, Tohoku University
Division name
Smart Aging International Research Center
Zip code
Address
Seiryou-machi 4-1, Aoba-ku, Sendai-shi, Miyagi-ken 980-8575, Japan
TEL
+81-22-717-7988
Homepage URL
tatibana@idac.tohoku.ac.jp
Sponsor or person
Institute
Smart Aging International Research Center, IDAC, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
the Japan Society for the Promotion of Science titled Grant-in-Aid for challenging Exploratory Research
No. 23650103
Organization
Division
Category of Funding Organization
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
| 2011 | Year | 09 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 11 | Day |
Last modified on
| 2011 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007498
