UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033930 |
|---|---|
| Receipt number | R000038699 |
| Scientific Title | The trial of the residential excercise training for children with autism spectrum disoreder |
| Date of disclosure of the study information | 2018/08/28 |
| Last modified on | 2018/08/28 23:12:51 |
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Basic information
Public title
The trial of the residential excercise training for children with autism spectrum disoreder
Acronym
The Hakuba trial
Scientific Title
The trial of the residential excercise training for children with autism spectrum disoreder
Scientific Title:Acronym
The Hakuba trial
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of the residential excercise training for children with autism spectrum disorder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total T score of the Child Behavior Check List
Key secondary outcomes
Score of the short version of the Sensory Profile
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The residential exercise training (the intervention group)
Interventions/Control_2
Treatment as usual
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
| 1 | years-old | <= |
Age-upper limit
| 13 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Children with autism spectrum disorder and their parents who have informed consents to participate in this study
Key exclusion criteria
None
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Tachibana |
Organization
National Center for Child Health and Development
Division name
Division of Infant and Toddler Mental Health, Department of Psychosocial Medicine
Zip code
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan 157-8535
TEL
+81-(0)3-3416-0181
tachibana-y@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Tachibana |
Organization
National Center for Child Health and Development
Division name
Division of Infant and Toddler Mental Health, Department of Psychosocial Medicine
Zip code
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan 157-8535
TEL
+81-(0)3-3416-0181
Homepage URL
tachibana-y@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Japanese Ministry of Health, Labour and Welfare
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 | 08 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 05 | 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 | 08 | Month | 28 | Day |
Last modified on
| 2018 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038699
