UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060856 |
|---|---|
| Receipt number | R000069324 |
| Scientific Title | A Pilot Randomized Controlled Trial of Web-Based Psychological Education for Parents of Adolescents with Internet Addiction |
| Date of disclosure of the study information | 2026/03/06 |
| Last modified on | 2026/03/06 20:58:11 |
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Basic information
Public title
A Pilot Randomized Controlled Trial of Web-Based Psychological Education for Parents of Adolescents with Internet Addiction
Acronym
A Pilot Randomized Controlled Trial of Web-Based Psychological Education for Parents of Adolescents with Internet Addiction
Scientific Title
A Pilot Randomized Controlled Trial of Web-Based Psychological Education for Parents of Adolescents with Internet Addiction
Scientific Title:Acronym
A Pilot Randomized Controlled Trial of Web-Based Psychological Education for Parents of Adolescents with Internet Addiction
Region
| Japan |
Condition
Condition
Problematic Internet Use
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This pilot randomized controlled trial will evaluate the effectiveness of a group receiving remote web-based psychoeducation via a smartphone app for parents of adolescents with internet addiction, comparing whether it reduces the severity of internet addiction compared to a waitlist control group
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Internet Addiction Test(IAT),the Compulsive Internet Use Scale (CIUS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the intervention group, one parent will remotely participate in 15- to 20-minute weekly web-based psychoeducation sessions using a smartphone app or computer, totaling six sessions. Assessments for efficacy and safety evaluation will be conducted at baseline (Week 0), at the end of the intervention (Week 7), and during the follow-up period (Week 18).
Interventions/Control_2
Parents and Adolescent in the waiting group will remain on hold without receiving the intervention. Assessments related to evaluation items will be conducted before the intervention begins and at the end of the intervention period; they will not be conducted during the follow-up period. However, if parents in the waiting group express interest in the web-based psychoeducation, this intervention will be administered a total of 6 times starting after the end of the intervention period (Week 7).
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
This study is intended for adolescent and their guardians who meet all of the following conditions:
1) The individual with internet addiction is adolescent aged 12 or older but under 18 at the time consent is obtained.
2) A guardian aged 18 or older (an adult) is cohabiting with the individual with internet addiction at the time consent is obtained.
3) The guardian participating in this study scores 50 points or higher on the Parent-Child Internet Addiction Test (PCIAT).
4) Adolescent and guardian have provided written consent for participation in this study, freely given after receiving full explanation and demonstrating sufficient understanding.
5) Adolescent is capable of completing self-administered questionnaires.
6) The guardian is sufficiently healthy to receive weekly cognitive behavioral therapy counseling support via smartphone at home for 6 weeks and does not have any physical or mental illness or disability that would interfere with receiving counseling support.
Key exclusion criteria
Adolescents with internet addiction and their guardians
1) When ongoing counseling support is difficult due to problematic behaviors such as self-harm (e.g., cutting) or severe domestic violence.
2)Individuals with comorbid severe psychotic disorders, bipolar disorder, substance dependence, or alcohol dependence, where discontinuation of cognitive behavioral therapy is anticipated due to worsening of these symptoms.
3)Individuals at imminent risk of suicide, where discontinuation of CBT is anticipated.
4)Individuals whose repeated antisocial behavior makes discontinuation of CBT anticipated.
5)Individuals with a serious progressive disease, where discontinuation of CBT is anticipated.
6)Individuals with difficulty maintaining contact with the researcher.
Other individuals deemed unsuitable for the safe conduct of this trial by the principal investigator or the assigned therapist.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Horita |
Organization
International University of Health and Welfare
Division name
School of Health Sciences at Narita
Zip code
286-8686
Address
4-3 Kozunomori, Narita City, Chiba
TEL
0476207779
horitah@ihwg.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Horita |
Organization
International University of Health and Welfare
Division name
School of Health Sciences at Narita
Zip code
2868686
Address
4-3 Kozunomori, Narita City, Chiba
TEL
08056954250
Homepage URL
horitah@ihwg.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
International University of Health and Welfare
Address
4-3 Kozunomori, Narita City, Chiba
Tel
0476-20-7701
horitah@ihwg.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
| 2026 | Year | 03 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | 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
| 2026 | Year | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069324
