UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of universal, CBT-based prevention program for children and adolescents
Title of the study (Brief title)	The efficacy of CBT-based prevention program for children and adolescents
Region	Japan

Condition
Condition	Elementary school children aged 10-13
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and acceptability of CBT-based universal program for reducing anxious and depressive symptoms
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 Strengths and Difficulties Questionnaire:SDQ The Children's Hope Scale Social Support Scale for Children:SSSC Child and Adolescent Mindfulness Measure:CAMM

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	Double blind -all involved are 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	CBT-based universal preventive intervention program
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	10 years-old <=
Age-upper limit	13 years-old >=
Gender	Male and Female
Key inclusion criteria	children attending the elementary school in grade 4-6
Key exclusion criteria	children not attending the school
Target sample size	260

Research contact person
Name of lead principal investigator	Eiji Shimizu
Organization	Graduate School of Medicine, Chiba University
Division name	Research Center for Child Mental Development
Address	1-8-1 Inohana, Chuouku, Chiba, Japan
TEL	043-226-2975
Email	eiji@faculty.chiba-u.jp

Public contact
Name of contact person	Yuko Urao
Organization	Graduate School of Medicine, Chiba University
Division name	Research Center for Child Mental Development
Address	1-8-1 Inohana, Chuouku, Chiba, Japan
TEL	043-226-2975
Homepage URL
Email	yurao@faculty.chiba-u.jp

Sponsor
Institute	Research Center for Child Mental Development, 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)

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	千葉県内の小学校 (An Elementary school in Chiba City)

Other administrative information
Date of disclosure of the study information	2012 Year 10 Month 03 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 09 Month 01 Day
Anticipated trial start date	2013 Year 01 Month 01 Day
Last follow-up date	2014 Year 03 Month 01 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	2016 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4754865/
Results
Other related information

Management information
Registered date	2012 Year 10 Month 02 Day
Last modified on	2016 Year 05 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010575