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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033358
Receipt No. R000038026
Official scientific title of the study Verification of the therapeutic effect given to a child with a mental problem by horse-mediated activity
Date of disclosure of the study information 2018/07/13
Last modified on 2018/07/11

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Basic information
Official scientific title of the study Verification of the therapeutic effect given to a child with a mental problem by horse-mediated activity
Title of the study (Brief title) The effect of horse-mediated activity
Region
Japan

Condition
Condition Autism, ADHD, Neurosis, etc
Classification by specialty
Psychiatry Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Using objective indicators such as self-esteem and social skills, we examine the therapeutic effect of horse mediated activity on children with mental problems.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Self-esteem (Rosemberg self-esteem rating scare)
once / 2 monthes, 12 monthes

Key secondary outcomes Social skills (S-M social life ability test)
Participation rate
once / 2 monthes, 12 monthes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Horse mediated activity
(1 hour / week * 12 monthes)
Interventions/Control_2
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
6 years-old <=
Age-upper limit
19 years-old >
Gender Male and Female
Key inclusion criteria Children aged 6-18 who are treated at the psychiatric clinic who is mentally problematic.
The child who can understand the meaning of the question. The child and their carer who obtained consent to research.
Key exclusion criteria The child who cannot understand the meaning of the question.
The child and their carer who don't obtained consent to research.
Target sample size 34

Research contact person
Name of lead principal investigator Chinatsu Hayashibara
Organization Seijoh University
Division name Division of Occupational Therapy, Faculty of Care and Rehabilitation
Address 2-172 Fukinodai, Tokai, Aichi 476-8588, Japan
TEL 052-601-6927
Email hayashibara-seijoh@umin.ac.jp

Public contact
Name of contact person Chinatsu Hayashibara
Organization Seijoh University
Division name Division of Occupational Therapy, Faculty of Care and Rehabilitation
Address 2-172 Fukinodai, Tokai, Aichi 476-8588, Japan
TEL 052-601-6927
Homepage URL
Email hayashibara-seijoh@umin.ac.jp

Sponsor
Institute Nagoya Ishida Gakuen, Seijoh University
Institute
Department

Funding Source
Organization Applying
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 13 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 07 Month 01 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 11 Day
Last modified on
2018 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038026

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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