UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002265 |
|---|---|
| Receipt number | 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 21:19:41 |
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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
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
tatibana@idac.tohoku.ac.jp
Sponsor or person
Institute
Department of Functional Brain Imaging, IDAC, Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002773
