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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037022
Receipt No. R000042131
Scientific Title Effectiveness of a multimodal sensory communication program in families having children with autism
Date of disclosure of the study information 2019/06/15
Last modified on 2020/06/11

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Basic information
Public title Effectiveness of a multimodal sensory communication program on families of children with autism
Acronym Effectiveness of a multimodal sensory communication program
Scientific Title Effectiveness of a multimodal sensory communication program in families having children with autism
Scientific Title:Acronym Effectiveness of a multimodal sensory communication program
Region
Japan

Condition
Condition autism spectrum disorder, family of children with autism spectrim disorder
Classification by specialty
Pediatrics Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine effectiveness of multimodal communication program in children with autism spectrum disorder
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes adaptive behavior in children
stress in parents
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 multimodal sensory communication
Humatitude
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
3 years-old <=
Age-upper limit
6 years-old >
Gender Male and Female
Key inclusion criteria autism spectrum disorder
Key exclusion criteria cerebral palsy, genetic disorders
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Toshihiro
Middle name
Last name Kato
Organization Kyoto University
Division name Graduate School of Medicine Department of Human Health Sciences
Zip code 6068507
Address 53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL 0757513819
Email kato.toshihiro.5z@kyoto-u.ac.jp

Public contact
Name of contact person
1st name Toshihiro
Middle name
Last name Kato
Organization Kyoto University
Division name Graduate School of Medicine Department of Human Health Sciences
Zip code 6068507
Address 53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL 0757513819
Homepage URL
Email kato.toshihiro.5z@kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Graduate School of Medicine Department of Human Health Sciences
Institute
Department

Funding Source
Organization Nihonseimei Zaidan
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Graduate School of Medicine Department of Human Health Sciences
Address 53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
Tel 0757513819
Email kato.toshihiro.5z@kyoto-u.ac.jp

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 京都大学

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 15 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
2019 Year 06 Month 11 Day
Date of IRB
2019 Year 06 Month 11 Day
Anticipated trial start date
2019 Year 06 Month 15 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 11 Day
Last modified on
2020 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042131

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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