UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preliminary study on improvement of interpersonal relationship function of child autistic spectrum disorder without intellectual impairment by animal robot (new type AIBO)
Title of the study (Brief title)	Study on interpersonal relationship function of child autistic spectrum disorder without intellectual impairment by animal robot
Region	Japan

Condition
Condition	autistic spectrum disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We clarify the effect of improvement of interpersonal relationship function of child autistic spectrum disorder without an intellectual impairment of animal type robot.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference in way of touch and play with regard to AIBO of children without ASD without MR and normal control
Key secondary outcomes	Changes in autistic symptoms after AIBO exposure

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Autistic group once a week for a total of 8 weeks, 1 time 10 minutes contact with an animal robot
Interventions/Control_2	normal group once a week for a total of 8 weeks, 1 time 10 minutes contact with an animal robot
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	12 years-old >=
Gender	Male and Female
Key inclusion criteria	Without Intellectual disability Autistic spectrum dsiorder
Key exclusion criteria	Child judged inappropriate by the attending physician
Target sample size	40

Research contact person
Name of lead principal investigator	kazuya ono
Organization	st.marianna university school of medicine
Division name	Neuropsychiatry
Address	2-16-1 sugao miyamae-ku kawasaki city kanagawa
TEL	044-977-8111
Email	kazuya.ono@marianna-u.ac.jp

Public contact
Name of contact person	kazuya ono
Organization	st.marianna university school of medicine
Division name	Neuropsychiatry
Address	2-16-1 sugao miyamae-ku kawasaki city kanagawa
TEL	044-977-8111
Homepage URL
Email	kazuya.ono@marianna-u.ac.jp

Sponsor
Institute	st.marianna university school of medicine
Institute
Department

Funding Source
Organization	st.marianna university school of medicine
Organization
Division
Category of Funding Organization	Other
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	2019 Year 03 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2019 Year 02 Month 01 Day
Anticipated trial start date	2019 Year 03 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	2019 Year 02 Month 15 Day
Last modified on	2019 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040878