UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042060 |
|---|---|
| Receipt number | R000047971 |
| 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. |
| Date of disclosure of the study information | 2020/10/20 |
| Last modified on | 2022/01/27 12:39:10 |
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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
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
maru-tkb@umin.ac.jp
Sponsor or person
Institute
Akashi medical center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047971
| 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 |
