UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The trial of the residential excercise training for children with autism spectrum disoreder
Title of the study (Brief title)	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	Yoshiyuki Tachibana
Organization	National Center for Child Health and Development
Division name	Division of Infant and Toddler Mental Health, Department of Psychosocial Medicine
Address	2-10-1 Okura, Setagaya-ku, Tokyo, Japan 157-8535
TEL	+81-(0)3-3416-0181
Email	tachibana-y@ncchd.go.jp

Public contact
Name of contact person	Yoshiyuki Tachibana
Organization	National Center for Child Health and Development
Division name	Division of Infant and Toddler Mental Health, Department of Psychosocial Medicine
Address	2-10-1 Okura, Setagaya-ku, Tokyo, Japan 157-8535
TEL	+81-(0)3-3416-0181
Homepage URL
Email	tachibana-y@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 05 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 08 Month 28 Day
Last modified on	2018 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038699