UMIN-CTR Clinical Trial

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