UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054341 |
|---|---|
| Receipt number | R000054622 |
| Scientific Title | Effects of Online Music Therapy for Children with Selective Mutism |
| Date of disclosure of the study information | 2024/05/08 |
| Last modified on | 2024/05/08 23:40:53 |
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Basic information
Public title
Effects of Online Music Therapy for Children with Selective Mutism
Acronym
Effects of Online Music Therapy for Children with Selective Mutism
Scientific Title
Effects of Online Music Therapy for Children with Selective Mutism
Scientific Title:Acronym
Effects of Online Music Therapy for Children with Selective Mutism
Region
| Japan |
Condition
Condition
Selective Mutism
Classification by specialty
| Psychiatry | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to examine the effects of Online Music Therapy for selective mutism children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SMQ-R(Selective Mutism questionnaire-Revised)
Key secondary outcomes
CBCL(Child Behavior Checklist)
Scale on Young children's Anxiety Tendencies
SSQ(School Speech Questionnaire)
SM-SCCS(Selective Mutism Social Communication Comfort Scale)
Selective Mutism Stage Scale for Online Intervention
Behavior outcomes
Post-interview
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The Online Music Therapy for this study will consist of 15 sessions of 1 hours each, once every two weeks. The sessions will be conducted using video communication on the Internet.
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
| 8 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Child
1. People with selective mutism whose age is around 3 to 8 years old at the time of obtaining consent.
2. People who have been reported by themselves, their families, or other relevant persons that the child has difficulty speaking in social situations (nursery schools, kindergartens, schools, etc.) for at least one month.
Parent
1. Parents of children who are eligible under the above conditions
Key exclusion criteria
Child
1.People who are judged to have difficulty participating in online music therapy due to hearing impairment, Movement disorder, etc.
2. People who are judged by the principal investigator to be inappropriate as research subjects.
Parent
1. People who are unable to utilize the application for receiving online music therapy.
2. People who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Inoue |
Organization
Tottori University
Division name
Department of Clinical Psychology, Graduate School of Medical Sciences
Zip code
683-8503
Address
86 Nishi-cho,Yonago-shi,Tottori Japan
TEL
0859386410
masahiko-inoue@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Chahara |
Organization
Tottori University
Division name
Department of Clinical Psychology, Graduate School of Medical Sciences
Zip code
6838503
Address
86 Nishi-cho, Yonago-shi, Tottori Japan
TEL
0859386410
Homepage URL
m21m4003z@edu.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
Funding Source
Organization
Tottori University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Clinical Psychology, Graduate School of Medical Sciences, Tottori University
Address
86 Nishi-cho, Yonago-shi, Tottori Japan
Tel
0859386410
m21m4003z@edu.tottori-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 08 | 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
4
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to delays in the data analysis of the latter two cases in this case.
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
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2023 | 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
| 2024 | Year | 05 | Month | 08 | Day |
Last modified on
| 2024 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054622
