UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058940 |
|---|---|
| Receipt number | R000067407 |
| Scientific Title | A Study on the Effects of Using Digital Pen Tablets on Parent-Child Communication and the Promotion of Psychological Functioning |
| Date of disclosure of the study information | 2025/08/30 |
| Last modified on | 2025/09/01 10:37:31 |
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Basic information
Public title
A Study on the Effects of Using Digital Pen Tablets on Parent-Child Communication and the Promotion of Psychological Functioning
Acronym
A Study on the Effects of Using Digital Pen Tablets on Parent-Child Communication and the Promotion of Psychological Functioning
Scientific Title
A Study on the Effects of Using Digital Pen Tablets on Parent-Child Communication and the Promotion of Psychological Functioning
Scientific Title:Acronym
A Study on the Effects of Using Digital Pen Tablets on Parent-Child Communication and the Promotion of Psychological Functioning
Region
| Japan |
Condition
Condition
Healthy individuals (parents and children), Psychological stress reduction, Communication promotion
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, declining parent-child communication and psychological stress have become significant concerns. This study aims to examine the effects of collaborative drawing activities using digital pen tablets on the quality of parent-child relationships and psychological well-being through enhanced communication.
Basic objectives2
Others
Basic objectives -Others
Evaluate the effects of parent-child collaborative drawing activities using digital pen tablets on communication promotion and psychological functions.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency and quality of parent-child communication at 12 weeks after intervention initiation
Key secondary outcomes
well-being
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Joint digital art activities using a pen tablet by parent and child
The intervention period is 12 weeks
Interventions/Control_2
No treatment control
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Child: A healthy individual who is an elementary school student (ages 6 to 12) at the time of registration
Guardian: A healthy individual who is the guardian of an elementary school child aged 6 to 12 at the time of registration
Key exclusion criteria
Individuals unable to provide informed consent,Individuals with a history of neurological disorders,Individuals with severe visual impairment,Individuals currently participating in other clinical studies,Individuals for whom study participation is difficult
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Tohoku University
Division name
Smart Aging Research Center
Zip code
980-8575
Address
4-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture,
TEL
022-717-8952
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Makiko |
| Middle name | |
| Last name | Miyasaka |
Organization
Tohoku University
Division name
Smart Aging Research Center
Zip code
980-8575
Address
4-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture,
TEL
022-717-8952
Homepage URL
makiko.miyasaka.e3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Wacom Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
Tel
0227284105
ec-med@grp.tohoku.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
| 2025 | Year | 08 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067407
