UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032483 |
|---|---|
| Receipt number | 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 | 2022/06/02 22:22:56 |
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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
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
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
horitah@iuhw.ac.jp
Sponsor or person
Institute
Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036852
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| Registered date | File name |
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