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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016162
Receipt No. R000018757
Scientific Title Application of Eclectic Art and CBT Therapy for Middle Childhood Anxiety Disorders in Rural Areas
Date of disclosure of the study information 2015/01/08
Last modified on 2015/01/08

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Basic information
Public title Application of Eclectic Art and CBT Therapy for Middle Childhood Anxiety Disorders in Rural Areas
Acronym Eclectic Therapy for Anxiety Disorders
Scientific Title Application of Eclectic Art and CBT Therapy for Middle Childhood Anxiety Disorders in Rural Areas
Scientific Title:Acronym Eclectic Therapy for Anxiety Disorders
Region
Asia(except Japan)

Condition
Condition study Finished
Classification by specialty
Pediatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test the effectiveness of Art and CBT Eclectic approach to middle childhood anxiety disorders
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes significant effect of therapy on all types of AD
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Art and CBT Eclectic therapy
Interventions/Control_2 Art and CBT Eclectic therapy + Guidance sessions for parents
Interventions/Control_3 Control group
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
9 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria cut off score Spence children Anxiety Scale (child version)
Key exclusion criteria cut off score OCD
Target sample size 61

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mohamed Sharif Mustaffa
Organization University Technology Malaysia
Division name Counseling center
Zip code
Address Malaysia, Johor, Skudai, UTM
TEL +81-06075536662
Email atefeahmadi59@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Atefeh
Organization University Technology Malaysia
Division name Faculty of Education
Zip code
Address skudai, UTM, Counseling Center
TEL +81-0601115127390
Homepage URL
Email atefeahmadi59@gmail.com

Sponsor
Institute Counseling Center UTM
Institute
Department

Funding Source
Organization Ministry of Higher Education
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Malaysia

Other related organizations
Co-sponsor Ministry of Education
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 University Technology Malaysia (Johor)

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
significant effect of therapy on all types of AD 
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
2013 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 01 Day
Last follow-up date
2014 Year 08 Month 04 Day
Date of closure to data entry
2014 Year 08 Month 05 Day
Date trial data considered complete
2014 Year 10 Month 05 Day
Date analysis concluded
2014 Year 12 Month 19 Day

Other
Other related information

Management information
Registered date
2015 Year 01 Month 08 Day
Last modified on
2015 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018757

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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