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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006324
Receipt No. 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

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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
Email

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
Email tatibana@idac.tohoku.ac.jp

Sponsor
Institute Smart Aging International Research Center, IDAC, Tohoku University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007498

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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