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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name