UMIN-CTR Clinical Trial

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	adolescents with internet addiction
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 adolescents with internet addiction is more likely to reduce the degree of internet addiction severity compared to the waiting list control group. Efficacy is verified in a pilot randomized controlled trial.In this research, we conduct surveys of questionnaires etc. for adolescents with internet addiction, but do not intervene directly, but remotely assist parents of adolescents with internet addiction, and intervention in a form to consult. The study design is a randomized controlled trial.
Basic objectives2	Others
Basic objectives -Others	This research provides a platform to remotely support parents of addicts who are in a state of internet addiction, and parents will be able to receive effective support at home. Also in the future there is a possibility that the adolescents with internet addiction 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	(Adolescents with internet addiction) 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 Group
Interventions/Control_2	Waiting list control 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 Internet addiction person must be a minor between the ages of 12 and 20 at the time the consent is obtained. 2) A parent or guardian who is at least 20 years old (an adult) must be living with the Internet addiction at the time the consent is obtained. 3) The Internet-addiction person must have scored 40 or more points on the Internet Assessment Test (IAT) self-administered questionnaire. 4) Adolescents and Adults who have received sufficient explanation, fully understand, and have given their free and voluntary written consent to participate in this study. 5) Adolescents must be able to answer the self-administered questionnaire. 6)Adults must be healthy enough to receive continuous Cognitive Behavioral Therapy consultation support once a week for 12 weeks at home via videoconferencing system, and must not have any physical or mental illness or disability that would interfere with the consultation support.
Key exclusion criteria	When adolescents with internet addiction and his/her parent, 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 Eiji Middle name Last name Shimizu
Organization	Graduate School of Medicine Chiba University
Division name	Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology
Zip code	2608670
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 Hideki Middle name Last name Horita
Organization	Graduate School of Medicine Chiba University
Division name	Department of Cognitive Behavioral Physiology
Zip code	2608670
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	Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Chiba University Hospital
Address	1-8-1 Inohana, Chuouku, Chiba, Japan
Tel	043-222-7171
Email	chibacrc@mac.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	千葉大学医学部附属病院（千葉県）

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	13
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	Completed
Date of protocol fixation	2018 Year 03 Month 20 Day
Date of IRB	2019 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 04 Month 16 Day
Last follow-up date	2022 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	2018 Year 05 Month 06 Day
Last modified on	2022 Year 06 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036852