UMIN-CTR Clinical Trial

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	Japan Science and Technology Agency
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	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	https://www.ieice.org/ken/paper/202105244CEb/,https://www.ieice.org/ken/paper/20200822h1ZZ/
Publication of results	Unpublished

Result
URL related to results and publications	https://www.ieice.org/ken/paper/202105244CEb/
Number of participants that the trial has enrolled	10
Results	We compared post-intervention behavioral changes between two cases of children at different developmental levels in terms of language, to reveal the effect of the intervention. The results showed an improvement in the child's initiation of communication, the mother's social response, as well as positive emotional expression during free-play in the both cases. However, we also observed a difference in the communication modalities for mother-child interactions between the two cases.
Results date posted	2022 Year 06 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Autism in 3-5 year olds and their mothers
Participant flow	All 10 study participants received the Humanitude educational intervention; 3 primary outcome analyses have been completed.
Adverse events	none
Outcome measures	Child's adaptive behavior using video coding
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Suspended
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	2022 Year 06 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042131