UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of community reinforcement and family training(CRAFT) at Japanese mental health center for concerned significant others of problem gamblers or substance-abusing indivisuals.
Acronym	The efficacy of community reinforcement and family training(CRAFT) at Japanese mental health center for concerned significant others of problem gamblers or substance-abusing indivisuals.
Scientific Title	The efficacy of community reinforcement and family training(CRAFT) at Japanese mental health center for concerned significant others of problem gamblers or substance-abusing indivisuals.
Scientific Title:Acronym	The efficacy of community reinforcement and family training(CRAFT) at Japanese mental health center for concerned significant others of problem gamblers or substance-abusing indivisuals.
Region	Japan

Condition
Condition	gambling disorder, substance use disorder
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of CRAFT at Japanese mental health center for concerned significant others of problem gamblers or substance-abusing indivisuals.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in SUBI(subjective well-being inventory) score from pre- to post-treatment(6 months, 12 months)
Key secondary outcomes	Change from pre- to post-treatment(6 months, 12 months) Rate of problem gamblers or substance-abusing indivisuals going to hospital, mutual-help group or consultation. Rate of concerned significant others going to hospital, mutual-help group or consultation. Relationship between problem gamblers or substance-abusing indivisuals and concerned significant others.VAS(visual analogue scale)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Monthly CRAFT(community reinforcement and family training),6 sessions problem gamblers or substance-abusing indivisuals
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Inclusion criteria 1.Concerned significant others(CSO) include parents,children,siblings,freiends and partners. 2.The CSO has a relationship with the problem gambler or substance-abusing indivisual at least 3 months. 3.The CSO is able to read and answer questions in Japanese.
Key exclusion criteria	Exclusion criteria 1.The CSO has acute psychiatric symptoms and needs starting or changing psychiatric treatments.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hiromune Middle name Last name Takada
Organization	Osaka prefectual mental health center
Division name	department of regional support
Zip code	5580056
Address	3-1-46 Bandaihigashi , Sumiyoshi-ku, Osaka-shi, Osaka prefecture, Japan
TEL	06-6691-2818
Email	TakadaHiro@mbox.pref.osaka.lg.jp

Public contact
Name of contact person	1st name Hiromune Middle name Last name Takada
Organization	Osaka prefectual mental health center
Division name	department of regional support
Zip code	5580056
Address	3-1-46 Bandaihigashi , Sumiyoshi-ku, Osaka-shi, Osaka prefecture, Japan
TEL	06-6691-2818
Homepage URL
Email	TakadaHiro@mbox.pref.osaka.lg.jp

Sponsor
Institute	Osaka prefectual mental health center
Institute
Department

Funding Source
Organization	Osaka prefectual mental health center
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Osaka prefectual mental health center IRB
Address	3-1-46 Bandaihigashi , Sumiyoshi-ku, Osaka-shi, Osaka prefecture, Japan
Tel	06-6691-2818
Email	kenkosogo-g25@sbox.pref.osaka.lg.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

Other administrative information
Date of disclosure of the study information	2019 Year 10 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	Open public recruiting
Date of protocol fixation	2019 Year 09 Month 27 Day
Date of IRB	2019 Year 10 Month 01 Day
Anticipated trial start date	2019 Year 10 Month 01 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	2019 Year 10 Month 01 Day
Last modified on	2020 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043513