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Recruitment status Completed
Unique ID issued by UMIN UMIN000008798
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email sumie-kato@chiba-u.jp

Sponsor
Institute Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology, Graduate School of Medicine, Chiba University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010274


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