UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032517
Receipt number R000037083
Scientific Title The efficacy of universal CBT-based anxiety prevention program for children and adolescents
Date of disclosure of the study information 2018/05/10
Last modified on 2024/11/13 09:29:09

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Basic information

Public title

The efficacy of universal CBT-based anxiety prevention program for children and adolescents

Acronym

The efficacy of universal CBT-based anxiety prevention program for children and adolescents

Scientific Title

The efficacy of universal CBT-based anxiety prevention program for children and adolescents

Scientific Title:Acronym

The efficacy of universal CBT-based anxiety prevention program for children and adolescents

Region

Japan


Condition

Condition

Elementary school children aged 10-13
Junior high school students aged 13-15
High school students aged 16-18

Classification by specialty

Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and acceptability of CBT-based universal prevention program for reducing anxious symptoms

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Spence Children's Anxiety Scale: SCAS

Key secondary outcomes

Depression Self-Rating Scale for Children:DSRS
Strengths and Difficulties Questionnaire:SDQ
Child and Adolescent Mindfulness Measure:CAMM


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

CBT-based universal anxiety prevention 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



Eligibility

Age-lower limit

10 years-old <=

Age-upper limit

18 years-old >=

Gender

Male and Female

Key inclusion criteria

Children attending the elementary school in grade 4-6
Students attending the junior high school in grade 1-3
Students attending the high school in grade 1-3

Key exclusion criteria

Children not attending the school

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name Eiji
Middle name
Last name Shimizu

Organization

Chiba University

Division name

Research Center for Child Mental Development

Zip code

2608670

Address

1-8-1 Inohana, Chuouku, Chiba, Japan

TEL

043-226-2975

Email

eiji@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Yuko
Middle name
Last name Urao

Organization

Chiba University

Division name

Research Center for Child Mental Development

Zip code

2608670

Address

1-8-1 Inohana, Chuouku, Chiba, Japan

TEL

043-226-2975

Homepage URL


Email

yurao@faculty.chiba-u.jp


Sponsor or person

Institute

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



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chiba University school of medicine

Address

1-8-1, Inohana, Chuoku, Chiba, Japan

Tel

043-226-2496

Email

inohana-kanri@office.chiba-u.jp


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

2018 Year 05 Month 10 Day


Related information

URL releasing protocol

https://link.springer.com/article/10.1186/s12888-023-05134-8

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1186/s13034-021-00374-6

Number of participants that the trial has enrolled

3022

Results

The results demonstrated that ten 45-min JOB sessions conducted in Japanese elementary schools, delivered by specially trained teachers, were associated with a statistically significant anxiety score reduction among the participating students, when compared with a control group.

Results date posted

2024 Year 11 Month 13 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Twenty-seven elementary schools participated: 1622 and 1123 children were allocated to the intervention and control groups, respectively. The intervention group received a programme comprising ten 45-min sessions, while the control group underwent the regular school curriculum.

Participant flow

In recruiting participating schools, we contacted member universities of the Kodomo Minna Project (http://www.kodomo-minna.jp/) through their cooperating education boards.
Each participating education board or university distributed an announcement letter soliciting participation, along with an application form and pamphlet explaining the content to jurisdictional elementary schools.
Thirty schools willingly participated in this study. They were geographically separated into three different areas: Chiba, Tottori, and Kyoto prefectures.

Adverse events

None

Outcome measures

The primary outcome of this study was changes in the SCAS Japanese version scores.
The SCAS is an anxiety scale that has been shown to have good psychometric properties and has been commonly used with children of various cultural backgrounds in multiple countries.
It contains six subscales generalised, anxiety disorder, separation anxiety disorder, social phobia, panic disorder and agoraphobia, obsessive compulsive disorder, and fear of physical injury.
Each item is rated on a 4 point scale in terms of its frequency, from never to always.
A total anxiety score is calculated by adding the 38 item' scores, with a maximum possible score of 114.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2018 Year 01 Month 15 Day

Date of IRB

2017 Year 06 Month 05 Day

Anticipated trial start date

2018 Year 02 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 05 Month 08 Day

Last modified on

2024 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=R000037083