UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008798 |
|---|---|
| Receipt number | R000010274 |
| Scientific Title | A controlled trial of group cognitive behavior therapy program, 'Fun FRINEDS' for grade 3 classes children in preventive effects of mental health of a Japanese elementary school |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2017/11/13 11:52:53 |
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Basic information
Public title
A controlled trial of group cognitive behavior therapy program, 'Fun FRINEDS' for grade 3 classes children in preventive effects of mental health of a Japanese elementary school
Acronym
A controlled trial of 'Fun FRINEDS' in a Japanese elementary school
Scientific Title
A controlled trial of group cognitive behavior therapy program, 'Fun FRINEDS' for grade 3 classes children in preventive effects of mental health of a Japanese elementary school
Scientific Title:Acronym
A controlled trial of 'Fun FRINEDS' in a Japanese elementary school
Region
| Japan |
Condition
Condition
Children aged 8-9 in elementary school
Classification by specialty
| Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and acceptability of the Fun Friends program in reducing anxiety and increasing self-esteem in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Spence Children's Anxiety Scale: SCAS
Key secondary outcomes
Depression Self-Rating Scale for Children: DSRS-C
Children's Hope Scale
Spence Children's Anxiety Scale-Parent Version: SCAS-P
Strength and Difficulties Questionnaire- Parent Version: SDQ-P
Strength and Difficulties Questionnaire-Teacher Version: SDQ-T
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Fun Friends Program based on cognitive behavioral therapy
Interventions/Control_2
Waiting
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
| 9 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All of the children who go to the school in grade 3
Key exclusion criteria
Non-attendance at school
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Shimizu |
Organization
Graduate School of Medicine Chiba University
Division name
Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology
Zip code
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sumie Kato |
Organization
Graduate School of Medicine Chiba University
Division name
Department of Cognitive Behavioral Physiology
Zip code
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
TEL
043-226-2027
Homepage URL
sumie-kato@chiba-u.jp
Sponsor or person
Institute
Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
東京都の小学校 (An Elementary school in Tokyo)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.sciencedirect.com/science/article/pii/S2212657016300484
Number of participants that the trial has enrolled
Results
The SCAS as the primary outcome showed no significant differences between the two groups. In addition, DSRS-C, Hope and SDQ-P also showed no significant differences. SCAS-P in the intervention group showed significant decrease compared to those in the control group.
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
| 2012 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 29 | Day |
Last modified on
| 2017 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010274
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
