UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055662 |
|---|---|
| Receipt number | R000059518 |
| Scientific Title | Online musical intervention to promote emotional stability and self-esteem improvement for abused children during the COVID-19 pandemic. |
| Date of disclosure of the study information | 2024/09/29 |
| Last modified on | 2024/09/28 18:01:07 |
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Basic information
Public title
Online musical intervention to promote emotional stability and self-esteem improvement during the COVID-19 pandemic.
Acronym
Online musical intervention to promote emotional stability and self-esteem improvement during the COVID-19 pandemic.
Scientific Title
Online musical intervention to promote emotional stability and self-esteem improvement for abused children during the COVID-19 pandemic.
Scientific Title:Acronym
Online musical intervention to promote emotional stability and self-esteem improvement for abused children during the COVID-19 pandemic.
Region
| Japan |
Condition
Condition
abused children in foster care
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we aim to investigate the effects of musical intervention on the mental and behavioral issues of abused children. Compared to pharmacological treatment, musical intervention, which has almost no adverse effects, is expected to show potential improvements in mental symptoms and behavioral problems. This could significantly contribute to the development of therapeutic approaches for children seeking psychiatric care. Considering the current impact of the COVID-19 pandemic, we plan to conduct the intervention online. Looking ahead, we anticipate that this approach could also have a significant impact on children in underserved areas, such as remote and island regions, where resources for healthcare and education are limited.
For children, the idea of hospital visits and pharmacological treatment can be daunting. Therapeutic intervention through a familiar and enjoyable medium like music is highly valuable. We believe in exploring the power of music not only to "resolve emotional distress," but also to "enrich lives" and "boost self-esteem."
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following items will be assessed before and after the intervention.
QIDS-J Quick Inventory of Depressive Symptomatology
AFQ-Y Avoidance and Fusion Questionnaire for Youth
SCAS Spence Children's Anxiety Scale
SDQ Strengths and Difficulties Questionnaire
ADHD-RS-4 ADHD Rating Scale
ABC-J Aberrant behavior checklist
SDQ-P Strengths and Difficulties Questionnaire
SCAS-P Spence Childrens Anxiety Scale
The above items will also be assessed at 3 and 6 months after the end of the intervention to verify the long-term progress.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The online environment will be used to teach the subject how to play guitar, drums, or any other instrument of his/her choice. There will be a total of 10 sessions every other week.
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
| 6 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The program will be open to those who meet all of the following criteria
1. Age: At least 6 years old and no older than 18 years old at the time of obtaining consent.
2. Gender: Any gender
3. Abused children in foster care facilities
4. Persons who have been fully informed about their participation in this study, and who have given their assent and written consent based on sufficient understanding by themselves or by their surrogate.
Key exclusion criteria
Persons who fall under any one of the following shall be excluded as eligible
1. Those whose age is less than 6 years old or more than 19 years old
2. Persons with hearing impairment
3. Persons with visual impairment
4. Other patients deemed inappropriate as research subjects by the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Fukumoto |
Organization
University of Fukui
Division name
Department of Neuropsychiatry, Faculty of Medical Sciences, University of Fukui
Zip code
9101193
Address
23-3, Matsuoka-shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan
TEL
0776613111
sinchan@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Fukumoto |
Organization
University of Fukui
Division name
Department of Neuropsychiatry, Faculty of Medical Sciences, University of Fukui
Zip code
9101193
Address
23-3, Matsuoka-shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan
TEL
0776613111
Homepage URL
sinchan@u-fukui.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Faculty of Medical Sciences, University of Fukui
Shintaro Fukumoto
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Department of Neuropsychiatry, Faculty of Medical Sciences, University of Fukui
Address
23-3, Matsuoka-shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan
Tel
0776613111
sinchan@u-fukui.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 | 09 | Month | 29 | 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
6
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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 | 09 | Month | 28 | Day |
Last modified on
| 2024 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059518
