UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033358 |
|---|---|
| Receipt number | R000038026 |
| Scientific Title | 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 10:38:25 |
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Basic information
Public title
Verification of the therapeutic effect given to a child with a mental problem by horse-mediated activity
Acronym
The effect of horse-mediated activity
Scientific Title
Verification of the therapeutic effect given to a child with a mental problem by horse-mediated activity
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Chinatsu Hayashibara |
Organization
Seijoh University
Division name
Division of Occupational Therapy, Faculty of Care and Rehabilitation
Zip code
Address
2-172 Fukinodai, Tokai, Aichi 476-8588, Japan
TEL
052-601-6927
hayashibara-seijoh@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chinatsu Hayashibara |
Organization
Seijoh University
Division name
Division of Occupational Therapy, Faculty of Care and Rehabilitation
Zip code
Address
2-172 Fukinodai, Tokai, Aichi 476-8588, Japan
TEL
052-601-6927
Homepage URL
hayashibara-seijoh@umin.ac.jp
Sponsor or person
Institute
Nagoya Ishida Gakuen, Seijoh University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038026
