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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002265
Receipt No. R000002773
Scientific Title A group randomized controlled trial of a play program for mother and child to enhance their mental health and children's cognitive development
Date of disclosure of the study information 2009/07/29
Last modified on 2019/02/03

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Basic information
Public title A group randomized controlled trial of a play program for mother and child to enhance their mental health and children's cognitive development
Acronym A group randomized controlled trial of a play program for mother and child to enhance their mental health and children's cognitive development
Scientific Title A group randomized controlled trial of a play program for mother and child to enhance their mental health and children's cognitive development
Scientific Title:Acronym A group randomized controlled trial of a play program for mother and child to enhance their mental health and children's cognitive development
Region
Japan

Condition
Condition Typically developped preschool children
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Enhancing children's cognitive development and improving mother and child's mental health
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Parenting Stress Index
New S-S intelligence test
DAM Goodenough draw-a-man intelligence test
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 The intervention group: The participants performs the play program for ten miniutes a day, five days a week, for three months.
Interventions/Control_2 The control group: The participants have ordinary 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
3 years-old <=
Age-upper limit
6 years-old >
Gender Male and Female
Key inclusion criteria The parents and children who understand the explanation of the present study and understand the explanation of the present study and consent to participate in
Key exclusion criteria Nothing
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuta Kawashima
Organization IDAC, Tohoku University
Division name Department of Functional Brain Imaging
Zip code
Address Seiryou-machi4-1, Aoba-ku, Sendai-shi, Miyagi-ken
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization IDAC, Tohoku University
Division name Department of Functional Brain Imaging
Zip code
Address
TEL
Homepage URL
Email tatibana@idac.tohoku.ac.jp

Sponsor
Institute Department of Functional Brain Imaging, IDAC, Tohoku University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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
2009 Year 07 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0038238
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
2009 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2014 Year 08 Month 01 Day
Date of closure to data entry
2014 Year 08 Month 01 Day
Date trial data considered complete
2014 Year 09 Month 01 Day
Date analysis concluded
2014 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 07 Month 29 Day
Last modified on
2019 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002773

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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