UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056011 |
|---|---|
| Receipt number | R000064007 |
| Scientific Title | Evaluation of the Effectiveness of Psychoeducational Videos for Parents on Addressing Children's Anxiety |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2025/02/03 12:11:09 |
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Basic information
Public title
Evaluation of the Effectiveness of Psychoeducational Videos for Parents on Addressing Children's Anxiety
Acronym
Evaluation of the Effectiveness of Psychoeducational Videos for Parents on Addressing Children's Anxiety
Scientific Title
Evaluation of the Effectiveness of Psychoeducational Videos for Parents on Addressing Children's Anxiety
Scientific Title:Acronym
Evaluation of the Effectiveness of Psychoeducational Videos for Parents on Addressing Children's Anxiety
Region
| Japan |
Condition
Condition
Anxiety symptoms
Classification by specialty
| Psychosomatic Internal Medicine | Pediatrics | Psychiatry |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effectiveness of psychoeducational videos on addressing children's anxiety, targeting parents of children aged 3 to 12.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Parenting Behaviors Questionnaire (1 week after the completion of intervention)
Key secondary outcomes
Confidence in Responding to Children's Anxiety
Parental Distress Regarding Responses to Children's Anxiety
Family Accommodation Scale-Anxiety (FASA)
Parental Acceptance and Action Questionnaire (PAAQ)
Revised Children's Anxiety and Depression Scale25-Parent Version (RCADS-P-25)
Health Questionnaire for Children and Young People (KIDSCREEN-10-Parent Version)
The World Health Organization-Five Well-Being Index (WHO-5)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Psychoeducational videos
Interventions/Control_2
No intervention
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Parents of children aged 3 to 12
(2) Individuals who have sufficient understanding of the Japanese language
(3) Individuals who are interested in learning how to respond to children's anxiety
Key exclusion criteria
(1) Individuals deemed inappropriate by the principal investigator
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Fujisato |
Organization
Kansai University
Division name
Faculty of Sociology
Zip code
564-8680
Address
3-3-35 Yamate-cho, Suita-shi, Osaka
TEL
06-6368-1121
fujisato@kansai-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Fujisato |
Organization
Kansai University
Division name
Faculty of Sociology
Zip code
564-8680
Address
3-3-35 Yamate-cho, Suita-shi, Osaka
TEL
06-6368-1121
Homepage URL
fujisato@kansai-u.ac.jp
Sponsor or person
Institute
Kansai University
Institute
Department
Personal name
Hiroko Fujisato
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Center of Neurology and Psychiatry
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, National Center of Neurology and Psychiatry
Address
Ogawahigashicho 4-1-1, Kodaira-shi, Tokyo, Japan
Tel
042-341-2711
rinri-jimu@ncnp.go.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 | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2025 | 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 | 11 | Month | 01 | Day |
Last modified on
| 2025 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064007
