UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058040 |
|---|---|
| Receipt number | R000066342 |
| Scientific Title | Implementation Study of a Large Language Model (LLM)-Based Support System for Families with Children Showing Signs of Internet Addiction |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/06/02 00:25:27 |
* 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
A Study on a Chat-Based Support Program for Families Concerned About Their Children's Internet or Gaming Use
Acronym
Network Engagement Support Tool via Chat:NEST-Chat
Scientific Title
Implementation Study of a Large Language Model (LLM)-Based Support System for Families with Children Showing Signs of Internet Addiction
Scientific Title:Acronym
Same as above
Region
| Japan |
Condition
Condition
Gaming Disorder,Habit and Impulse Disorders
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to develop and evaluate a chat based support system for families with children exhibiting signs of Problematic Internet Use or Problematic Smartphone Use Building on the Community Reinforcement and Family Training framework the system integrates microlearning content for parental stress management a Prescription of Words function using LLMs with RAG for empathic feedback and a self logging tool to record family dynamics Unlike conventional parental control apps this tool focuses on enhancing the parent child relationship through emotional selfcare and constructive engagement The goal is to provide early stage support for families not yet connected to clinical or social services using natural language processing technologies to deliver personalized scalable assistance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
PHQ-9
Key secondary outcomes
Generalized Anxiety Disorder 7
Gaming Disorder Scale for Parents
Internet Addiction Test
Short Form of the Parent Child Relationship Scale
Emotion and Concern Log
Conversation Logs
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants in this group begin using the support app immediately after enrollment. Over 12 weeks, they access features such as Prescription of Words LLM-based empathic responses, microlearning content for parental stress management, and emotional problem logging tools to support constructive family interaction.
Interventions/Control_2
Participants in this group do not receive any intervention for the first 12 weeks waitlist period. After week 12, they begin using the same support app and features as Intervention 1. The preintervention period allows for comparison between groups at T12.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Parents or guardians living with children aged 10 to 24 who are suspected to have, or are at risk of, Problematic Internet Use or Gaming Disorder
Individuals who are currently receiving interpersonal support from medical, governmental, or educational institutions
Parents or guardians must be 18 years of age or older
Individuals who understand the study content and have provided written informed consent
Individuals who are able to read, write, and operate devices in Japanese
No restrictions will be placed on gender.
Key exclusion criteria
Individuals who are deemed to have significant difficulty participating in the study due to cognitive impairment or related conditions
Individuals in the acute phase of psychiatric illness e.g., severe depressive state or strong suicidal ideation, where participation may pose a risk to the parent or guardians well being
Individuals who are unable to sufficiently understand the study content, making appropriate informed consent unfeasible
Any other individuals whom the principal investigator or co-investigators deem unsuitable for participation in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nanase |
| Middle name | |
| Last name | Kobayashi |
Organization
Institute of science Tokyo
Division name
Cyber Psychiatry
Zip code
1528550
Address
2-12-1 Ookayama, Meguro-ku, Tokyo 152-8550, Japan
TEL
03-3726-1111
nanase.psyc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Same |
| Middle name | |
| Last name | Same |
Organization
Same
Division name
Same
Zip code
Same
Address
Same
TEL
03-3726-1111
Homepage URL
nanase.psyc@tmd.ac.jp
Sponsor or person
Institute
IST
Institute
Department
Personal name
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ERC, Faculty of Medicine, Tokyo Institute of Science
Address
2-12-1 Ookayama, Meguro-ku, Tokyo 152-8550, Japan
Tel
03-3726-1111
none
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 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | 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 | 06 | Month | 02 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066342
