UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058999 |
|---|---|
| Receipt number | R000067475 |
| Scientific Title | Development of a family-based prevention program for problematic internet use among children and adolescents |
| Date of disclosure of the study information | 2025/09/08 |
| Last modified on | 2025/09/05 08:25:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of a family-based prevention program for problematic internet use among children and adolescents
Acronym
Development of a Family-Based Prevention Program for PIU
Scientific Title
Development of a family-based prevention program for problematic internet use among children and adolescents
Scientific Title:Acronym
Development of a family-based prevention program for PIU
Region
| Japan |
Condition
Condition
Problematic Internet Use (PIU)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a family-based preventive intervention as a primary prevention program for elementary and junior high school students and to evaluate its effectiveness through a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Children's problematic internet use measured by the Japanese version of the PIUQ short form
Key secondary outcomes
1) Children's daily internet use time (weekdays and weekends)
2) Family functioning
3) Parental control
4) Perceived stress of parents
5) Parenting resilience
6) Children's evaluation and comprehension of the program
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
A 60-minute group session will be conducted every week for 4 weeks
Interventions/Control_2
Provide a pamphlet on the prevention of PIU
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
| 10 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Children in grades 5 through 9 (elementary grade 5 to junior high grade 3) and their parents
2) Children who use the internet regularly for recreational purposes
3) Those who have provided written informed consent
Key exclusion criteria
1) Individuals who have difficulty reading, writing, or speaking in Japanese
2) Individuals who are unable to attend at least two of the four sessions
3) Individuals whom the investigators judge to be unsuitable for the safe conduct of this trial
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Saya |
| Middle name | |
| Last name | Moriyama |
Organization
University of Tsukuba
Division name
Graduate School of Comprehensive Human Sciences, Degree Program in Counseling Science
Zip code
112-0012
Address
3-29-1 Otsuka, Bunkyo-ku, Tokyo 112-0012, Japan
TEL
03-3942-6918
saya.moriyama@ken-zan.co.jp
Public contact
Name of contact person
| 1st name | Saya |
| Middle name | |
| Last name | Moriyama |
Organization
University of Tsukuba
Division name
Graduate School of Comprehensive Human Sciences, Degree Program in Counseling Science
Zip code
112-0012
Address
3-29-1 Otsuka, Bunkyo-ku, Tokyo 112-0012, Japan
TEL
03-3942-6918
Homepage URL
saya.moriyama@ken-zan.co.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Saya Moriyama
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Area Research Ethics Committee, Faculty of Human Sciences, University of Tsukuba
Address
3-29-1 Otsuka, Bunkyo-ku, Tokyo 112-0012, Japan
Tel
03-3942-6918
saya.moriyama@ken-zan.co.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
筑波大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | 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
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 | 07 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2026 | 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 | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067475
