UMIN-CTR Clinical Trial

Basic information
Public title	Introducing family training program of alcohol use disorder to CSOs from non-specialist hospital project.
Acronym	Introducing family training program of alcohol use disorder to CSOs from non-specialist hospital project.
Scientific Title	Recruitment Concerned Significant Others from non-specialist hospital to CRAFT (Community Reinforcement And Family Training) based family training program in specialist hospital of alcohol use disorder from non-specialist hospital.
Scientific Title:Acronym	RCC (Recruitment CSO to CRAFT) project
Region	Japan

Condition
Condition	Alcohol use disorder
Classification by specialty	Medicine in general Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the effect of introducing family training program heled in the specialist psychiatric hospital (Tarumi hospital) to central significant others (relatives, friends or partner) who are closely related with alcohol use disorder patients from non-specialist hospital (Akashi medical center).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The score change of "Mental Health" of SF-36 before and after program
Key secondary outcomes	1. participation rate of Concerned significant others (CSOs) in Community Reinforcement and family training (CRAFT) based group program (number of participants at the end of research/number of recruited CSOs) 2. Change of the score of SF-36 before and after program [vitality, social functioning, role-emotional] 3. Change of the score of Relational Happiness scale before and after program 4. treatment entry rate of identified person (IP, patient of alcohol use disorder) [observational study for IPs] 5. reasons for participating CRAFT based group program of all participants of CRAFT based group program (participants choice one of following reason; introduced from the same hospital holding CRAFT based group program, introduced from other hospital, introduced from other public agency, other reason) [observational study for other participants]

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Introduce CRAFT based group program to CSOs by staff (nurse, doctor, clerk, or social worker) non-psychiatric hospital(Akashi medical center). CRAFT based group program is held in specialist psychiatric hospital for alcohol use disorder (Tarumi hospital). Finish of intervention is defined by 8 times participation of CRAFT based group program. The program is held by 2 experienced psychotherapists or social workers who are engaged in family education of alcohol use disorder patients for more than 3 years. The program is designed as 8 distinct 90-minutes-session. Each program is independent and included essence of original CRAFT program. Sessions are held every 2 weeks, and recruited CSOs can participate any session continuously or intermittently. No intervention for IPs and other participants of CRAFT based group program.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	CSOs (1)Answer yes in Q1, and no or unknown in Q2. Q1 "Are you in trouble with alcohol use of your significant other(Identified person, IP)?" Q2 "Is the IP treated as alcohol use disorder?" (2)I The IP fulfills 2 or more criteria of DSM-5 substance use disorder (judged by CSO). II The IP was not treated as alcohol use disorder more than 3 months before entry. III The CSO hopes to keep contact with the IP. No inclusion criteria for IPs and other participants of CRAFT based group program.
Key exclusion criteria	CSOs: (1) have problem of substance use. (2) have any psychiatric disease need treatment. (3) have a history of serious violence by IP. (4) have severe psychotic or physical conditions that could impair ability of participation. No exclusion criteria for IPs and other participants.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Kaneko
Organization	Akashi Medical Center
Division name	General Internal Medicine
Zip code	674-0063
Address	743-33, Yagi, Ohkubo-cho, Akashi City, Hyogo Prefecture
TEL	0789361101
Email	qhnqj628@gmail.com

Public contact
Name of contact person	1st name Tomoko Middle name Last name Hirata
Organization	Akashi medical center
Division name	Safety control department
Zip code	674-0063
Address	743-33, Yagi, Ohkubo-cho, Akashi City, Hyogo Prefecture
TEL	0789361101
Homepage URL
Email	maru-tkb@umin.ac.jp

Sponsor
Institute	Akashi medical center
Institute
Department

Funding Source
Organization	Akashi medical center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Akashi medical center
Address	743-33, Yagi, Ohkubo-cho, Akashi City, Hyogo Prefecture
Tel	0789361101
Email	maru-tkb@umin.ac.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	明石医療センター（兵庫県）、垂水病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 20 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	0
Results	We terminated this project, because number of participant is very limited and is not expected to be increased under the COVID-19 pandemic era.
Results date posted	2022 Year 01 Month 27 Day
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	Terminated
Date of protocol fixation	2020 Year 10 Month 05 Day
Date of IRB	2020 Year 10 Month 05 Day
Anticipated trial start date	2020 Year 10 Month 27 Day
Last follow-up date	2023 Year 03 Month 30 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 10 Month 09 Day
Last modified on	2022 Year 01 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047971