UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039578 |
|---|---|
| Receipt number | R000045137 |
| Scientific Title | Pilot randomized controlled trials for Family support program development and effectiveness verification for gaming disorders |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2021/01/21 13:56:32 |
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Basic information
Public title
A study on the development and evaluation of efficacy on a family support program for gaming disorder
Acronym
A study on a family support program for gaming disorder (FASP-G)
Scientific Title
Pilot randomized controlled trials for Family support program development and effectiveness verification for gaming disorders
Scientific Title:Acronym
Family support program development for gaming disorders and pilot randomized controlled trials
Region
| Japan |
Condition
Condition
Gaming disorder, Family
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a new family support program to facilitate the visit of a youth with gaming disorder to a medical or consultation facility.
Basic objectives2
Others
Basic objectives -Others
Verification of the effectiveness of randomized controlled trials
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Obtaining an informed consent to visit a medical or consultation facility from a youth with gaming disorder for up to 6 months after the finish of the program
Key secondary outcomes
Rated by parents:
1) Time spent on gaming in their child
2) Severity of gaming disorder in their child
3) Game-related issues in their child
4) Anxiety level of a family
5) Depression level of a family
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) 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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A 120-minute group session will be conducted every week for 6 weeks
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
| Not applicable |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Parents who live with a child with gaming disorder, who has visited neither a medical nor consultation facility.
2) At the time of obtaining an informed consent, a child with gaming disorder is 25 years old or younger.
4) Parents from whom a written informed consent are obtained.
Key exclusion criteria
1) Parents who are unable to read and write Japanese and communicate in Japanese.
2) Those who will be unable to attend at least 4 sessions out of 6 sessions.
3)Those whose child has already visited a medical and/or consultation facility.
4) Those who have already consulted to a medical facility or have taken a similar program for parents.
5) Those who have difficulty in participating in the program due to domestic violences and/or self-injuries of a child with gaming disorder or comorbid psychiatric disorders of parents.
6)In case, investigators of this study judges that parents are not appropriate for participating in this study due to safety reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Mihara |
Organization
National Hospital Organization Kurihama Medical and Addiction Center
Division name
Department of Clinical Psychology
Zip code
239-0841
Address
5-3-1, Nobi, Yokosuka, Kanagawa, Japan
TEL
+81-46-848-1550
mihara.satoko.pd@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Mihara |
Organization
National Hospital Organization Kurihama Medical and Addiction Center
Division name
Department of Clinical Psychology
Zip code
239-0841
Address
5-3-1, Nobi, Yokosuka, Kanagawa, Japan
TEL
+81-46-848-1550
Homepage URL
mihara.satoko.pd@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kurihama Medical and Addiction Center
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
National Hospital Organization Kurihama Medical and Addiction Center IRB
Address
5-3-1, Nobi, Yokosuka, Kanagawa 239-0841, Japan
Tel
+81-46-848-1550
mihara.satoko.pd@mail.hosp.go.jp
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
独立行政法人国立病院機構久里浜医療センター/National Hospital Organization Kurihama Medical and Addiction Center
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | 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
22
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 24 | Day |
Last modified on
| 2021 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045137
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
