UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037022 |
|---|---|
| Receipt number | 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 | 2022/06/14 10:43:40 |
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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
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
kato.toshihiro.5z@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Graduate School of Medicine Department of Human Health Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042131
