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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032483
Receipt No. R000036852
Scientific Title Pilot-randomized controlled trial of remote cognitive behavioral therapy for guardians of online dependent minors
Date of disclosure of the study information 2018/06/01
Last modified on 2018/05/06

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Basic information
Public title Pilot-randomized controlled trial of remote cognitive behavioral therapy for guardians of online dependent minors
Acronym A Study on Remote Cognitive Behavior Therapy for Parents of Internet Dependent Minors
Scientific Title Pilot-randomized controlled trial of remote cognitive behavioral therapy for guardians of online dependent minors
Scientific Title:Acronym A Study on Remote Cognitive Behavior Therapy for Parents of Internet Dependent Minors
Region
Japan

Condition
Condition Internet addiction Adult
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A group that provides cognitive behavioral therapy remotely from a television conference system targeting a net dependent dependent minor is more likely to reduce the degree of net dependence severity compared to the waiting list control group Efficacy is verified in a pilot randomized controlled trial.
Basic objectives2 Others
Basic objectives -Others In this research, we conduct surveys of questionnaires etc. for minors who are in a state of net dependence, but do not intervene directly, but remotely assist parents of internet dependent minors And intervention in a form to consult. The study design is a randomized controlled control study.
This research provides a platform to remotely support parents of addicts who are in a state of net dependence, and parents will be able to receive effective support at home. Also in the future there is a possibility that the Internet dependent minor may be able to receive remote assistance.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes IAT (Internet Addiction Test)
Key secondary outcomes (Minor)
Percentage of use per day for Internet mined by the minor
Japanese version EQ - 5D - 5L
M.I.N.I. (Japanese version 5.0.0 (2003))
(Parents)
Period of use of minors by parents on the Internet per day
The Japanese version of EQ-5D-5L
Young Diagnostic Questionnaire (DQ)
Client Satisfaction Questionnaire (CSQ-8J)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are 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
Maneuver
Interventions/Control_1 cognitive behavioral therapy
Interventions/Control_2 Non-intervention group
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
12 years-old <=
Age-upper limit
20 years-old >
Gender Male and Female
Key inclusion criteria 1) The person who is dependent on the net is a minor who is 12 years old and under 20 years old when obtaining consent.
2) At the time of obtaining consent, parents of 20 years old (adult) are living together with those who depend on the net.
3) The dependency on the Internet is more than 40 points on the internet addiction test (IAT) self-report questionnaire.
4) At the participation of this examination, minors and guardians who are fully acquainted with explanation and who have obtained document consent by free will with sufficient understanding.
5) Minors should be able to answer self-written questionnaires.
6) Parents are healthy enough to continuously receive consultation support by cognitive behavioral therapy using the video conference system at home at least once a week for 12 weeks, so that mental and physical disorders , having no obstacles.
Key exclusion criteria Net addiction dependent minors and parents,
1) It is difficult to continuously provide consultation support due to self-injurious behavior such as a list cut or problem behavior such as remarkable domestic violence.
2) Persons who are expected to have cessation of behavioral cognitive therapy because of severe psychotic disorder, bipolar disorder, drug dependence, alcohol dependence etc merged and these symptoms worsen.
3) Persons who are expected to have cessation of cognitive behavioral therapy because of the danger of impending suicide.
4) Persons who are anticipated to have cessation of cognitive behavioral therapy because they repeat antisocial acts.
5) Persons who are predictive of interruption of cognitive behavior therapy because they have serious progressive disease.
6) Persons who are difficult to contact with researchers.

In addition, a person who judges that it is inappropriate for the examination responsible doctor or the test sharing therapist to safely perform this examination.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Shimizu
Organization Graduate School of Medicine Chiba University
Division name esearch Center for Child Mental Development, Department of Cognitive Behavioral Physiology
Zip code
Address 1-8-1 Inohana, Chuouku, Chiba, Japan
TEL 043-226-2027
Email eiji@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Horita
Organization Graduate School of Medicine Chiba University
Division name Department of Cognitive Behavioral Physiology
Zip code
Address 1-8-1 Inohana, Chuouku, Chiba, Japan
TEL 043-226-2027
Homepage URL
Email horitah@iuhw.ac.jp

Sponsor
Institute Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization Sodegaura Sotsukendai 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
Address
Tel
Email

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
2018 Year 06 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
2018 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 06 Day
Last modified on
2018 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036852

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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