UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059097 |
|---|---|
| Receipt number | R000067604 |
| Scientific Title | The Effectiveness of Cognitive Behavioral Therapy (CBT) for Parents Facing Difficulties in Managing Their Children's Problematic Internet Use: A Single-Center, Waitlist-Controlled, Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/16 16:32:53 |
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Basic information
Public title
The Effectiveness of Cognitive Behavioral Therapy (CBT) for Parents Facing Difficulties in Managing Their Children's Problematic Internet Use: A Single-Center, Waitlist-Controlled, Randomized Controlled Trial
Acronym
i-CRAFT Study
Scientific Title
The Effectiveness of Cognitive Behavioral Therapy (CBT) for Parents Facing Difficulties in Managing Their Children's Problematic Internet Use: A Single-Center, Waitlist-Controlled, Randomized Controlled Trial
Scientific Title:Acronym
i-CRAFT Study
Region
| Japan |
Condition
Condition
Problematic Internet Use
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effectiveness of a Cognitive Behavioral Therapy (CBT) program based on Community Reinforcement and Family Training (CRAFT) for parents who have difficulty managing their children's problematic internet use, as compared to a waitlist control group. The primary endpoint will be the score on the Parent version of the Internet Addiction Test (PCIAT), and a significant improvement in this score will be considered evidence of the program's effectiveness. This study aims to build more robust evidence, which is essential for establishing a new support method for adolescents who are resistant to treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in the Parent version of the Internet Addiction Test (PCIAT) score from baseline (week 0) to post-intervention (week 12).
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
A Cognitive Behavioral Therapy (CBT) program based on Community Reinforcement and Family Training (CRAFT). A total of 6 face-to-face sessions will be conducted once every two weeks, with each session lasting 30 minutes, over a period of 12 weeks.
Interventions/Control_2
Participants will wait for 12 weeks without receiving the intervention. During this period, no specific study intervention will be provided, and usual medical care will continue. After the waiting period, the same CBT program as the intervention group will be offered to those who wish.
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
Parents who have difficulty managing their child's problematic internet use.
Parents of a child who is currently an outpatient at the Psychiatry Department of Chiba Children's Hospital.
Parents whose child is between 6 and 18 years of age (inclusive) at the time of informed consent.
Parents who are living with the child at the time of informed consent.
Individuals who have provided voluntary, written informed consent after receiving a full explanation of the study.
Parents who are able to participate in the 12-week face-to-face CBT program and do not have any serious physical or mental illness that would hinder their participation.
Key exclusion criteria
Parents who are determined to have difficulty participating in the CBT program due to factors such as significant cognitive impairment.
Parents who have received CRAFT-based family therapy or equivalent systematic parent training within the past 6 months.
Parents who have difficulty attending a 30-minute session every two weeks on a continuous basis.
Individuals otherwise deemed unsuitable for safe participation in the study by the principal investigator.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Kawagishi |
Organization
Chiba Children's Hospital
Division name
Department of Psychiatry
Zip code
266-0007
Address
579-1 Hettacho, Midori-ku, Chiba, 266-0007, Japan
TEL
043-292-2111
ryo.kawagishi7@gmail.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Kawagishi |
Organization
Chiba Children's Hospital
Division name
Department of Psychiatry
Zip code
266-0007
Address
579-1 Hettacho, Midori-ku, Chiba, 266-0007, Japan
TEL
043-292-2111
Homepage URL
ryo.kawagishi7@gmail.com
Sponsor or person
Institute
Chiba Children's Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba Children's Hospital
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
Chiba Children's Hospital
Address
579-1 Hettacho, Midori-ku, Chiba, Japan
Tel
043-292-2111
ryo.kawagishi7@gmail.com
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 | 10 | 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 | 10 | Month | 01 | 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 | 09 | Month | 16 | Day |
Last modified on
| 2025 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067604
