UMIN-CTR Clinical Trial

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
Email	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
Email	mihara.satoko.pd@mail.hosp.go.jp

Sponsor
Institute	National Hospital Organization Kurihama Medical and Addiction Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045137